ML20138P531

Request for OMB Review & Supporting Statement Re 10CFR21 Concerning Reporting of Defects & Noncompliances.Estimated Respondent Burden Is 72,000 H

ML20138P531
Person / Time
Issue date:	11/04/1985
From:	Norry P NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
OMB-3150-0035, OMB-3150-35, NUDOCS 8511070220
Download: ML20138P531 (9)

Text

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....ri.~. ~, Request 1or 0MB Review m:c.m_,  %  % ,

important ' W of Jy y Reac instructions before cernpk ing toint Do cet use the sanie SF S3 Send three copies of thdrW >

• e r ia te . . . wed. .mo toe to request both an Esecutive Orcer 12291 review md approvat under paperwork-three copies of the supporting s!.s , (

the Paperwork Reduction Act Answer all questions in Part 1. If this request is for rewew uncer LO. Office of Information and Regulatory Atfars 12291, complete Part it and sign the regutatory cert.fication if this Office of Management and Budget request is for approvat under the Paperwork Reduction Act and 5 CF R Attention: Docket bbrary. Room 3201 1320, skip Part 11, complete Part Hi and sign the pape work certification. Washington. DC 20503 PART l.-Complete This Part for All Requests-

1. Depaf tment/ agency and baraa etMe oogmating request ' 2. N 'U y i b" U.S. 11uclear Regulatory Commission >

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3. Nar**e of person wno can best answer questions regarders tms request telephune numbe, E. Jordan (301 )492-4848

4. Title of information collecten or rulemah mg 10 CFR Part 21 Reporting of Defects and lioncompliances.

S. Legas authority for er tcrmation to; erticn or ruie (cite ()citec States Code. Pubisc Law, or i necur ne Orcer) 42 usc J201(o) , c.,. _ _ . _

6. Affected pubhc (checir s!!that apply) 5 C recera; egenc,es c, emogr.s 1 C Indmduais or households a C ra,ms e C Non p,o,.iinstitet.ons 2 C stateoriocatcovernments 4 Q eusinesses orother v or. profit 7 E smari bus.nesses or o,ganizations PART ll.-Complete [his Part Only if the Request is for OMB Review Under Executive Order 12291

7. Reguistion identif:er Number (RIN)

_ _ _ _ ~ _ _ _ _ . or, f4cr.e i.ss;gnad C S. Type of submession (chech one en each catescry) Type of review requested Classtficatoon stage of development 1 stancarc 1 C Mac u 1 C Proposed ct dratt 2 C F endir'g 2 C fJenmayr i' r a .or mtermi tr/ W1;ow r'opmai 3 C Emegemy r -,

3 FM or .<mm te v. t%t g.r.or propru 4u Statutory (s y o 6,W ne

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10. Oces th*s refutation contain reportq cr reardhe et.ng te ausrements tnt recurre OfAfl approvat urede e the Paperwork Reductiori / et are 5 CF R 13207 L_; Ye, ,}' .

11. If a major ruie, is there a regutatc'y .mpact analna atra d ec' 1 C Yn 2 [.I te it' No " did OfAB war.e the arsaws' 3[iin 4 [ ] tm C2rtificction f u Regulatory Submissions in subm.ttirg this request for OfAB review, the authoeiroc revoiatory (cet.ar t a n.14 e pretrarn officu l c ret.f y it.at the recuoerrects < t i G 12hl an t 'w appt i ame co'ft C.rettives hve tree r rnoved nth 5 re at ste of pr^ gram etf C.'n i ')J ' e

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PART lli.-Ccmpute This Part Only if the Rsqu2st is for Approval of a ",ollection of Information Under the Paperwotk Reduction Act and 5 CF R 1320. _j

13. Abstrsct-Descr.be needs. uses and af tected pubbe in 50.,ords or less --

" Nuclear Facilities, Nuclear Reactors, Equipment, Defects, Noncompliance." Part 21 results in reports describing defects in basic components at nuclear facilities licensed by the NRC.

There are 12,000 organizations that are potentially affected, but only 100 per year are actual respondents.

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14. Type of mformation collection (checA only one) litormation collections not contanned in rules i 1 O Regular submiss,on 2 O Emergency submission (cert,r, car,onattached) information collections contaaned in rules 3 3 Existmg regulaticn (no charge proposed) 6 Final or mtenm final without prior NPRM 7. Enter date of espected or actual Federal 4 C Notice of proposed ru:emakmg(NPRM) A O Reguiar submission Register pubocation ae this stage of ruiemaking 5 Fmai. NPRM was previously pubbshed 8 O Emergency submission (cert,rication trached) (month, day. year)

15. Type of review requested (checA only one) 1 O New conecte 4 0 Remstatement of a previousiv approved coiiection for wnich aperovai has enpered

, 2 @ Revision of a currently approved collection j 3 Extense of the expiration date of a currently approved cellection b O Existing collection in use without an OMB control number i wtr9ut any change m the substance or m the method of collection

16. Agency report form number (s}(onclude standard / opt,onal form number (s)) 22. Purpose of mtormate coelecteon (Check as many as apply) g 1 O Apphcation for benefits 2 O erogramevaivation

17. Annu 1 reportmg or disclosure burdea a O ceneraipurposestatatics 1 Nurnber of respondents . 100 4 g p,guatory o,compnance

, 2 Number of responses per respondent 4.5 5 0 erogram pianningor management

, 3 Total annual responses (hne 1 times hne 2) 450 e O Research

! 4 Hours per response .

I60 7 Audit j 5 Total hours v,ne 3 times on, o 72,000 j 18. Annualrecordheepergburden 23. Frequency of recordheepmg or reportmg(choca a# that apply) 1 Number of recordkeepers 100 1 g Recordheep,ng

) 2 Annual hours per recordheeper 6 fleperWng

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3 Tot:1 recordkeeping hours (kne 1 times hoe 2) 600 2 @ onoccasion 4 Recordbeepmg retention period Ljfe years 3 w,,ggy j 19. Tot:1 annual burden 4 O Montney 1 Requested (kne 17 5 plus hoe 18 3) . IEa000 s Quarterfy 2 in current ou8 mventory 84.000 e O sern..annuairy j 3 Ditierence (hne l iess Ane 2) -11.400 7 O Annually bpl: nation othtference 8 0 8,ennontty 4 Prqram charye

-11,400 9 0 otner(describe) 5 Ad.ustrnent .

20. Currsot (most recent) oMB controt cuenber or comment number 24. Respondents' obhgation to comply (chec A the strongest obhgate thatapphet) 3150-0035 i O voiuntary

21. Requested empirate cate 2 O Requi,.6 to oeiain or retain a benefit (

l/31/89 3 3 Mandator, I

) 25. Ars the respondents primari y educational agencies or mstrtutions or is the primary purpose of the collection related to Federal educate programs?

f Yes d] No

26. Does the agenc use sampling to select respondents or does the agency rec.ommend or prescribe the use of samphng or statistical analyse by r*spondents . O ves K1 No

27. Rcgulatory authority for tne mtormahon collectm 10 crp M . or FR .or.otherfsgec,f,)

F perworde^rtification in sutett r1 M rectest it CUf3 nPn at it e epmt y t ead the u m r e rtio.v a an aper' red repe:.entative. (ertibes that the requircruents cf S Cf H 13N. the j briva( y 8'C t. sW'*,t cp

• f 7N'a'd5 t' r do e* (Wei ar ej any oths-t Pf pl4at.h etos rNim past.) C 'erias a t ave (seer) f t'fMplwd with

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j s gnatwe v ar.y h,ad, tsc ww e va, o, an auinorved rep even ative Date Patricia G. Norrys Director, Office of Administration O% //- o e-4 CIO i tW4 0 - 4 S b Ur'

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OM8 SUPPORTING STATEMENT FOR 10 CFR 21 DESCRIPTION OF THE INFORMATION COLLECTION 10 CFR 21.21 requires directors and responsible officers of firms and organizations building, operating, owning or supplying safety-related compo-nents to NRC licensed facilities, or conducting NRC licensed activities, to report defects in components and failures to comply with regulatory require-ments which could create a substantial safety hazard. 10 CFR 21.51 requires each organization subject to 10 CFR Part 21 to maintain such records as may be '

required to assure compliance with Part 21.

i A. JUSTIFICATION

1. Need for the Collection of Information.

! Part 21 was designed to implement Section 206 of the Energy Reorganization Act of 1974 (42 U.S.C. 5846). Section 21.21 requires directors and responsible officers ~of firms and organizations building, operating, or owning NRC licensed facilities, or conducting NRC licensed activities, to report defects in components and failures to comply with regulatory requirements which could create a substantial safety hazard. Also covered under the regulation are directors and a ~

responsible officers of firms and organizations supplying safety-rela,ted components, i including safety related design, testing, inspection and consulting services. is NRC licensees and other organi.ations covered by Part 21 must adopt internal 4

procedures to assure that safety-related defects and noncompliance are brought to the attention of responsible officers and directors. j<

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• n Those individuals, in turn, are required to notify the Commission within two days, and file a written report within five days, of learning of the defect or noncompliance.

Pursuant to Section 21.51 each organization subject tc 10 CFR Part 21 shall maintain such records as may be required to assure compliance with Part

21. Each individual, corporation, partnership, or other entity subject to Part 21 is required to prepare records in connection with the design, manufacture, fabrication, placement, erection, installation, modification, inspection or

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testingsof any facility or to be used in any licensed activity sufficient to assure coypliance with Part 21.

~2. Agency Use ok Information.

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j Part 21, the Commission's regulation implementing Section 206, results in reports describing defects in basic components at licensed nuclear facilities.

These reports are reviewed by the NRC staff to determine whether the reported defects or failures to comply are potential generic safety issues. These 1

reports of potential safety problems have resulted in many NRC bulletins, circulars, and information notices, and have contributed to the improved safety of the nuclear industry.

The reporting requirement of Section 21.21 is intended to assure that the Commission gets prompt notification concerning defects or failures to comply in facilities or activities licensed by the Commission. The records maintained pursuant to Section 21.51 are subject to review by the Commission staff to 4

determine compliance with Part 21. Records maintained pursuant to S21.51 fall into four categories. One category consists of records relating to evaluations defined by $21.3(g). Another category consists of records of previously submitted reports pursuant to $21.21.. The third category consists of records of procedures required to assure compliance with Part 21. The last category consists of procurement documents necessary to ensure that background specifi-cations are available to evaluate potential defects.

3. Reduction of Burden Through Information Technology.

There are no legal obstacles to reducing the burden associated with this information collection, in fact industry organizations (INPO, AIF) are urged to share and distribute such information to all affected parties as it becomes available. The NRC further disseminates significant generic information to all affected parties via Bulletins and Information Notices and encourages elimina-tion of duplicate reports. Automated systems for tracking reports are being developed by NRC and industry and are being utilized to the extent possible.

4. Effort to Identify Duplication.

Commission regulations contain several safety deficiency reporting require-ments. Although distinctions exist between these requirements, instances have i

occurred where the same deficiency was evaluated by two different organiza-tions, one attempting to satisfy the criteria of Part 21 and the other attempt-ing to meet the differently worded criteria of 10 CFR 50.55(e). Although the original intent was for reporting under only one of these requirements to satisfy the other reporting requirements, in reality, this intended method of reporting has not occurred.

The staff is planning to revise the regulations to eliminate this duplica-tion. The intent of the proposed revisions is to establish the filing of one report for each defect, with the reporting obligation resting on the entity that discovers the deficiency.

5. Effort to Use Similar Information.

10 CFR Part 21 was designed to implement Section 206 of the Reorganization Act of 1974 (42 U.S.C 5846). As such it is the only regulation which currently requires directors and responsible officers of firms and organizations building, operating, or owning NRC licensed facilities, or conducting NRC licensed activi-ties, to report defects in components and failures to comply with regulatory requirements which could create a substantial safety hazard. As such, similar usable information is not currently available within NRC or industry to accora-plish the intended purpose of Section 206 of the reorganization Act of 1974.

6. Effort to Reduce Small Business Burden.

Approximately 12,000 organizations, licensees, and non-licensees, are under the scope of Part 21. Approximately 450 reports are submitted to the NRC annually under Part 21 by approximately 100 respondents. A majority of these respondents are not considered small businesses. The NRC has studied the possi-bility of reducing the burden on small businesses and has concluded that it would not be possible to lessen the burden on small businesses and still receive reports required by Section 206 of the Energy Reorganization Act.

7. Consequences of Less Frequent Collection.

This rule requires reporting of defects which could create a substantial safety hazard. As such it has no specific period for reporting but rather l

requires reporting as the need arises. Less frequent collection of such information could reduce the NRC effectiveness in the areas of assessing potential generic safety issues and in disseminating such information to affected parties.

8. Circumstances which Justify Variation from OM8 Guidelines.

There are no known variations from OMB guidelines.

9. Consultation Outside the NRC.

The staff has utilized comments from the industry on the Part 21 reporting system in developing its requirements. The staff is also currently preparing rulemaking to revise 10 CFR Part 21 and $50.55(e) which will include industry comments,and the recommendations of the Presidential Commission on the Accident at Three Mile Island (Kemeny Commission) relating to the safety defect report system.

10. Confidentiality of Information.

Information which is identified as proprietary or confidential, which by being disclosed will do substantial harm to an organization's competitive position, could be withheld from disclosure under a Freedom of Information Act request if the Commission determines that it is in the public interest to withhold it.

11. Justification for Sensitive Questions. l This rule does not request sensitive information.

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12. Estimate of the Cost to the Federal Government.

The annual NRC staff time expended on Part 21 evaluations is approximately 20,700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> (450 reports x 46 hours5.324074e-4 days <br />0.0128 hours <br />7.60582e-5 weeks <br />1.7503e-5 months <br />) or $1,242,000 (at $60.00 per hour). This estimate includes one hour per telephone notification (total of 450 hours0.00521 days <br />0.125 hours <br />7.440476e-4 weeks <br />1.71225e-4 months <br />), 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> to review each report (total of 25 x 450 = 11,250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br />), and 9000 hours0.104 days <br />2.5 hours <br />0.0149 weeks <br />0.00342 months <br /> i annually for review of records.

13. Estimate of Burden.

a. Estimated Hours Required to Respond to the Collection.

Approximately 100 respondents submit under S21.21 with a total of approxi-mately 450 reports per year, each report requiring an average of 160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> to i prepare. The annual industry time expended on $21.21 is approximately 72,000 hour0 days <br />0 hours <br />0 weeks <br />0 months <br />s-(160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> x 450 reports) at $4,320,000 (based on $60.00 per hour of  ;

professional staff time). The burden for $21.51 record keeping is 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> (100 record keepers x 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> per record keeper).

i j The total annual burden for reporting and record keeping is 72,600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> I

annually at $4,356,000 (based on $60.00 per hour of professional staff time).

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b. These estimates of burden are based on contacts with respon-

) dents. A survey of respondents indicates a wide variation (20 to 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br />) exists in estimates for the reporting burden. The staff's estimate of 160 l hours is a estimate based on the survey information.

, 14. Reasons for Change in Burden.

4 The burden estimated here represents a decrease of 11,400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> in indus-4 try burden estimated under the current clearance. The estimate more accurately c ,

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t j represents burden to respondents based on discussions with respondents. There has been an increase in estimated burden to report under this rule with a i significant estimated decrease in record keeping burden.

I i 15. Publication for Statistical Use.

The data collected through this rule provides the input for generic information notices and bulletins. Each report is tabulated in a computerized

] data system and tracked to resolution. The data contained in the computerized i system is not published except as it is reflected in notices and bulletins.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS i .

1 Statistical methods are not used in the collection of information.

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