ML20128H451
| ML20128H451 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1992 |
| From: | Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| To: | Murley T Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML20127C273 | List: |
| References | |
| FRN-57FR55443, RULE-PR-26 AD61-2-003, AD61-2-3, NUDOCS 9302170041 | |
| Download: ML20128H451 (2) | |
Text
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NUCLEAR REGULATORY COMMISSION 001 j
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MEMORANDUM FOR:
Thomas E. Murley, Director Office of Nuclear-Reactor Regulation FROM:
Gerald F. Cra', ford, Director office of In'.ormation* Resources Management
SUBJECT:
PARTIAL DIFAPPROVAL OF OMB CLEARANCE FOR FINAL RULE, 10 rFR 26, FITNESS FOR DUTY On January 6, 1992, NRC submitted a request for OMB review of the I
information collections contained in the final rule, Fitness for I
Duty,10 CFR 26.24 (d) (2) (iv) and 26.71(d).
On February 25, 1932 OMB received a letter from the Wuclear Management and Resources, Council (NUMARC) objecting to the added information collection at 526.71(d). This collection requires that, as part of the currently required biannual report of fitness-for-duty program performance
- data, licensees also submit data on the number of temporary suspensions or other administrative actions taken against individuals based on onsite positives for mari and cocaine, including appeals and their resolutions. juana- (THC)
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that this reporting requirement was not in the proposed rule and, NUMARC objected therefore, had not received public comment.
NUMARC believes that NRC has provided no basis for requiring submittal.of this data, as the raw data are already avr.ilable-to NRC.
In a May 7_, 1992, meeting among representatives from NRC, OMB, and NUMARC, NRC indicated that the _ additional information is being requested to establish a database for monitoring possible future needs to amend the 10 CFR'Part 26 regulation.
As indicated in the enclosed " Notice of Office of Management and Budget Action" dated May 26, 1992, OMB' approved the information collection contained in $26.24(d)(2)(iv), but. disapproved the information collection contained in 526.71(d), stating that WRC has demonstrated no compelling need for the additional data.
OMB also indicated that the raw data are already available to NRC, and cited 5 CFR 1320.4 (b) (3) as a reminder that NRC cannot seek to minimize its costs by shifting disproportionate costs or. burdens to the public.
The final rule became effective September 25,19S1, subject to OMB approval of the two additional information collections.
Since OMB disapproved the additional collection contained in $26.71(d), NRR pust either amend the final rule to delete this collection or c btain a Commission override, as addressed in NRC Manual Chapter
-230,
" Collection.= of Information and Reports Management," to impose the information collection disapproved by OMB.
In either 9302170041 930204 PDR PR
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oMB's approval.of tho' information collections contained ~in
$ 26. 2 4 (d) (2) (iv).-
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If - you have any questions or~ should you.need assistence, please.
contact Brends Jo. Shel n at.492-8132.
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r erald F. c anford,:D actor
'T ffi s of Information-Resources Management
Enclosure:
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-August 14 c1992 m
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I James B. MacRae, Jr.
f Acting' Administrator and
. Deputy Administrator
-mg Office of Information and Regulatory Affairs 4
Office of Management and Budget
' Washington,-D.C. 20503
Dear Mr. MacRae:
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4 This is in response to youreletterLof June 26,~1992lin which OMB disapproved W
the information collection request?(ICR) associated withitheifina1Lamendments promulgated by the Nuclear Regulatory CommissionE(Commission)1 to:10:CFR Partsi
-2. and 35i entitled, " Quality Management Programtand Misadministration."s OMB4 f
- concluded that this information. collection request is not necessary;forithe
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s n 4' proper performance of the. functions off the agency and;thattthe:informationD will-not have practical-utility for. the _ agency.w.This -letter also:addressesi
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' your prtial disapprovallof the-ICR; associated'with amendmentsLto'the fitness, a
for dutyr ele in 10 CFR Part -26, as reflected in your letters of/May:26?l9921 r
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and July 20,J1992.
The Commission fully supports the objectivesiofcthe' Paperwork 1 Reduction lAct?
-d and strives? to ensure that theiprivateisector isl requested 7toimaintainorJ provide only such informationLas isineeded to:carrysoutiregulatory 1 m
responsibilities. EIn thisivein,'uponireconsideration,ithesCommissionidoesinot!
fdisagree;with your' conclusions regarding information collection requirementsi.
.inTour fitness for-duty rule; iThe Commission'will-issue conforming changesLto:
1 Laccount for and: accommodate yourscomments and partia11 disapproval lofith_e ICRf p~
a sinLthose regulations-.in the'near fut'ure.
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- 0n th'e other ha.nd, for reasons specified below,1pursuantoto'44lU.S.C.$3507(c),'
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the Nuclear-RegulatoryJCommission has decided to override 1theOM81. -
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-M idetermination and requests that yourfoffice promptly assign a control number l to the information-collection-request' associated:with the Quality Management)..
andiMisadministration Rule:for a-period:of 3?yearse
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c Inlits'-implementing: regulations! OMB' specifies f(5~ CFR 1320.11,1320.4(L)h
- Land, (c)) that in_ approving an.-information collection request ::it1 evaluates w 4
(1) the. agency has chosen the least. burdensome means to obtain thet information, (2) the information sought is available toithe agency throughT 4
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James B. HacRae, Jr. August 14, 1992 some other means, and (3) the information sought has practical utti.ity.
Practical utility is defined (5 CFR 1320.7(o)) only as usefulness to the agency, taking into account the information's accuracy, adequacy, and reliability, and the agency's ability to process the information in a timely fashion.
Your disapproval of the ICR does not indicate that the information collection requirements are an unnecessarily burdensome way to obtain information about misadministrations and medical quality management programs, or that the information is available through some other means. Your disapproval relies on the third evaluation criterion described above and makes a finding of no practical utility.
But, contrary to 5 CFR 1320.7(o), you do not discount the accuracy, reliability or adequacy of the information sought, or challenge the Commission's ability to process the inic K ion in a timely fashion.
Your disapproval indicates that you have concNwd that there is no need for the Commission's final rule and regulatory program to reduce injuries from misadministration and that, therefore, any paperwork burden that.the rule would impose is unreasonable.
The Commission -- which is the agency charged with substantive responsibility
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for making such judgments -- continues to believe that its requirement for written quality management programs and misadministration reports,1f complied with, has a reasonable likelihood of decreasing misadministrations (e.g. wrong dose or wrong patient) with a small incremental cost to licensees. Without the reporting and recordkeeping requirements, it would not be possible to implement and enforce these regulations effectively.
The Commission will continue to monitor implementation and inspection under the rulo to assure that it provides the Commission with necessary information without imposing undue burden on the private sector.
If the Commission finds the rule, in whole or in part, to be overly burdensome or ineffective, it will consider modifying or deleting portions of the rule. Further, the NRC will hold a public workshop with the medical community and other interested parties, to assure that there is mutual understanding as to the intent of the rule, especially its information collection requirements, and to discuss effective implementation.
In particular, we will discuss the extent to which L
we can use the industry's self-auditing guidelines.
Following the workshop, the Commission will develop additional guidance on compliance with the rule, written in clear language appropriate to the medical community.
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James B._MacRae, Jr.
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-August 14,'1992 1-(
l Certification of the Override The Commission certifies that, by unanimous vote',~ it has overridden the Office of Management and Budget's disapproval of the information collection.
request associated with the final amendment to-10 CFR Parts 2 and 35' entitled -
' Quality Management Program and Misadministration."
Sincerely,-
Originalsigned by
. lames M4 Taylor-James H. Taylor-Executive Director-
-for Operations Distribtuion:
JMTaylor JHSniezek HLThompson JBlaha E00 7876-EDD rf-WParler.
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1 At'the. August 12, 1992 Commission meeting the formal-vote lWas-3-0 with: Commissioners-Rogers:and Curtiss not-
.present.
Commissioners Rogers and Curtiss both-indicated that they; agreed with the majority:and would also have_ voted formally to override if they could have been present at the meeting.
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