ML20012E913

Request for OMB Review & Supporting Statement Re 10CFR31 Concerning General Domestic Licenses for Byproduct Matl. Estimated Respondent Burden Is 5.50 H

ML20012E913
Person / Time
Issue date:	03/27/1990
From:	Amenta J NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0016, OMB-3150-16, NUDOCS 9004090078
Download: ML20012E913 (11)

Text

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$'""'"*"" 8 5 Request for 0MB Review

'" d (Rev Septemier 1983) fgj fhg important

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C" Ecad instructions tefore completing form Do not use the same $r 83 Send three copiestf this form, the material to be reviewed, and for to request both an Executive Order 12291 review and approval uncer paperwork-three copies of the supporting statement, to:

the Paperwork Reduction Act.

Answer all cuestions in Part 1. If this reauest is for review under E.O.

Office of Information and Regulatory Affairs 12291, complete Part il and sign tne regulatory certification. If this Office of IAanagement and Budget teouest is for approval under the Paperwork Reduction Act and 5 CFR Attention: Docket Library, Room 3201 1320. skip Part it. complete Part lit and sign the paperwork t ertification.

Washington, DC 20503 PART l.-Complete This Part for All Requests.

1. Wp;rtmentj agency ano Bureau /ottice onginating reauest 2.Agenc>cooe U.S. Nuclear Reuglatory Comission 3

1 5 0

3. htm2 et person no can oest ans.e, auestioni eegareing this reauest Te'epnone numoer Sterling Bell

( 301 ) 492-0617 43itie of information conection or rulemmns 10 CFR Part 31 - General Domestic Licenses for Byproduct Material

b. teq al authente tor information coi ecuon or ru+e (cite unnea States Cooe Putoc taw. or laccurwe Orper) 42 2201(o) g

6. Att:cted public (checA allthat appi)J Federai agencies or employees 1 C 'noividuals or househoics 3 C Farms 6 w Non profitinstitutions 2 1 State or localgovernments A 1 Businesses or other for.proht 7 C( $ mall businesses or o'gan;2ations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291

7. Rtrulation Icentifier Numtier (RIN)

_ __ _. or. None assigned C

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E hre of suomession (ca ca one er each cate'go y)

Type of renew reeueared e

C:ssetication Stage of development 1 C Standard 1 C Maior 1 O Proposed or draft 2 C Pending 2 C Nonmaior

? O Finalorintenmfinal,withpnorproposal 3 C Emergency 3 C Finai or intenm final, witnout pnor proposal 4 C Statutory or judicialdeadline 6 CF R section strectec CFR 10 Docs this reguistion cor taen reporting or recorekeeping reovirements tnat reovire oMB approval unoer the Paperwork Reduction Act and b CFR 1320?

. O yes C No

11. lf a maior rule,is there a regulato'v impact anaivsts attached?

1 C yes 2 C No l'"No " did OMB waive the analysis'

. s C ves 4 C No Certification for Regulatory Submissions in submitting this reauest for oMB review, the authorized regulatory contact and the program official certify that the requirements of E.o.12291 and any applicable policy directives have been Compheo with bigranure ce prug am official Date i

5Tnature of autnoriteo reguiatory contact Date

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12. TOMB use only)

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Premis cortions onsowie g3 gog 6tanoare f orm 83(kew 9 83; NSN MO DO 6%4034 Presenbed by OMB 5 CrR 1320and Lo.1229)

V PART lit.-Complete This Part Only if the Roguest is for Approval of a Collection of Information Underthe Paperwork Reduction Act and 5 CFR 1320.

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13. Atistract-cesenbe needs, uses and effected public in So words or less

" Radioactive Materials, Radiation Safety" 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material in certain items and a general license for ownership of byproduct material.

14. Typ of 6nformation col 6ection (check only one)

Informatten ceIIect6ene not containentIn ruses 1 O 9eguiar suomission 2 O tmersoney submission (certit.cetionettecheo>

I:lermetton collectione centeined in ruten 31 bisting regulation (no charige proposed) 6 Fmal or entenm final without pnor NPRM

7. Enter cate of expected or actual Feoerae 4 0 Notice of proposed ruiomaking(NPRM)

A O Regularsubmission Reg, ster publication at this stage of rulemaning 5 0 Final, NPRM was previcully published 8 O Emersency submission (certir, car.on ertsches)

(month. cer > ear >-

15. Type of review roovested (check only one) 1 O New collection 4 O Remstatement of a previousiv approved coiiection for which sporovni

"*' '" P' *d 2 O Revision of a currentry approved coiiection 31 Diension c. the enoiration date of a currently approved collection 5 O Existins coiiection in use without an oMB controi number without any c:nange m the substance or m the method of collection

6. Agency report form number (s)(tr'eluce standard /optionst form number (s))

20. Purpose of information collection (checA as many as apply) 2 O Appiication for benefits NA 2 O Program evaluation

17. Annual reportmg or aisclosure burcen 3 O Generalpurposestatistics l

69.000 4 @ Reguistoryorcompiiance 1 Number of responoents.

2 Number obesponses per iesponcent 0.01 5 O Program piannmg or management 3 Tetal annual responses (hne I times isne 2) 653 6 O Research et Hours per retoonse O.46 7 O Audit JJ91al hours reno 3 ree, free D 299 1J. Ant'usi recorcepeping ourcen

23. Frecuency of recorckeepmg or reportmg(cheen sti rnarappry) 5.000 3 g Recoroeeping i N imber of recoraweepers 2 Annual nours per recorakeeper, 0.1 no,erten, 3 Total recorcheeoing hours (line 1 times line 2) 500 2 @ onoccasion 4 Rscordweceir retention Denod 3 year $

3 0 weekiy 2 D. Totai nnnual burcen 4 O Montnir i Recuested r/ter 17 5 plus lee 18 3).

799 s O ouarteriy 2 in et.rrent oMB mventory 749 6 O semeannuany J Difference (line 1 Iess titie /)

2.749 7 O Annuany E.ctanation et difference 8 O Biennialty a Prog'arn change 3.50 9 0 otherreescribe>:

5 Ad!ustmentCu_Ctent estimate 5.50

20. Current tmest recent) CMB contrel number or comment number

24. Respondents' obligation to comply (check the strorfest obigerson that applies) 3150-0016 3 g voi,nt,,y

21. Recuesteo expirotion cate 2 O Recuired to obtam or retain a benefit 3 years from approval date 3 50 vancato,y

25. Are the respo, cents onmaniy educational agencies or institutions or is the primary purpose of the collection related to Federal education programs? O ves @ No

26. Does the agenc use sampling to select responcents or does the agency recommend or presenbe the use of sampling or statistical anaiysis by responcents

, O yes @ No i.

27. Regulatory avtnanty for tne information cotiection 10 cFR Part 31

or FR

or.Other(specify);

Paperwirk Certification in submittirig this request for oMB approval, the agency head, the senior official or en autnonzed representative, certifies that the requirements of 5 CFR 1320. the Pnvicy Act, statist: cal stancarcs or directives. and any other applicable information policy directives have been compiled with.

I Signature o' prog am official Date l

Signature of agency neaa. the senior official or en autnortrea representative Date Joyce A. Amenta, Designated Senior Offici 1 for Information Ronnurces Mannaament N

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7 ART lil.-Complete This Part only if the Roguest is for Approval of a Collection of information Under the Paperwerk Reduction Act and 5 CFR 1320.

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13. Atstract-cacnbe needs, uses and effected putme in 50 words or less

" Radioactive Materials: Radiation Safety" 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material in certain items and a general license for ownership of byproduct material.

l

14. Type of 6nformaten col 6ecten (check only one)

Inferr'id!Jen todfeetdene not centedned in reise 1O e3eguiarsubm'sesort 2 O Emergencysuomission(cert,ric.tenerrschea>

Inermat6en colooettene senteined in runee 3 E batmg regulation (no cherqrt proposea) 6 Final or intenm final without pnor N*RM

7. Enter cate of expected or actual Federai 4 O Notco of proposed rulemakmg(NPRM)

AO Reguiarsubm.sion Register put*caten at inn stage of ruiomaning 5 O rinai NpRM.as previousi,pubi.h.d eO Emergencysubmissen(certireetenett chea)

(moata cer reer>:

! 6. Type of review roovested (check onsy one) 10 New collection 4 O Remetatement of s previousiv approved coii.ctioti for wnien approvai h***'P"'d 2O Revisenof acurrentiyapprovedcoliocton 3 E Extension cii the eroiration cate of a currently approved coisection 5 C bating collection in use without an OMB control numter w'thout any enante in the substance or m the method of conection

16. Agency reocrt form rumperts)(include stenderatoptenalIbem number (s))

22. Purvon of intormation conection (check es many as apply) 1 O Apphcation for benefits NA 2 O Programevaluation

17. Annual reportma or disclosure buroen 3 O cenereipurposestatistics 1 Number of responoents.

1L000 4 E Reguisto y or compiiance 0.01 5 O Program pienning or management 2 Number of 'esponses per responcent 3 Tctal ennual responsen (ftne 1 times ime 2) 653 s O Researen 4 Hours por tesponse 0.46 7 O Audit 5 Totai neurs ('tae 3 h=ce Inne o 299

&J. Annual recorokeeping oureen

23. Frequency of recorckeeping or reportmg(checa allinatappry) 5.000 1 g Reco,emoeping 1 Number of recorckeeoers O.I nepntsng 2 Annust hours per recorakeeper.

3 Total recorakeeoing riours (lme 1 temos ime 2) 500

,2 $ on ocenion 4 Recorciseeome retention period 3 years 3 O weekty

19. Total annual bureen 4 O Monthly 799 5 O overteriy 1 Requestto (9ae 17 5 plus Ime 18 3).

2 in ct.rrent oMB mventory 749 6 O Semiannually 3 Difference (line f less imel) 2.749 7 O Annusur aapiensiden of difflerence a O sienniaiiy

'4 Program change 3.50 9 O other(vesenb.):

6 Ad!ustmentcurrent estimate 5.50 i

20. current amoet recent) oMe control numter or comment number

24. Respondents' obhgation to comply (check the strongest oblqtatet thatapplies) 3150-0016 1 O voluntary 1

21.Roguenten empiration osto 2 O Required to obtain or retain a benefri l

3 years from approval date s E Manoaiory 2ff. ArJ the resoondents onmenty educational agencies or instrtutens or a the pnmary purpose of the collection related to Federal educat6cn programst O yes @ No

26. Does the agencf use sampimg to setect respondents or does the agency recommend or prescribe the use of samphng or statistical analysm.... O by resooncents 27,Repetory outnority for the mformation conection l

W 10-~

- crR Part 31

er FR

or.other(specsty):

W Paperwork Certification in submstting this request for oMB approval, the agency head, the semor official or an authorued representative, certifies that the requirements of 5 CFR 1320. the Prevoor Act, statatical standaroe or directives, and any other applicable 6nformation poicy directives have been comphed with.

gpor program official-Date y..t M,

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pet spacy naso, the semor officiel or en authorund representative Date t$

1 "tscerAr Amenta, Designated Senior Offici 1 a

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'far Ininemation Reenurene Mananament

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c SUPPORTING STATEMENT FOR 10 CFR PART 31 GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL Justification Need for and Agency Use of the Information Collection l

Section 31.5 of 10 CFR Part 31 establishes a general license for certain measuring, gauging, or controlling devices. The devices contain byproduct material and are designed and manufactured for the purpose of detecting, i

measuring, gauging or controlling thickness, density, level, interface

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location, radiation, leakage, or qualitative or quantitative chemical l

composition, or for producing light or an ionized atmosphere. The devices, which may be distributed to general licensees by persons who are specifically licensed to do so, are manufactured under strict quality control standards and prototype testing. These controls provide reasonable assurance that under conditions of ordinary use and by persons not having training in radiation protection, the devices can be operated safely and without radiological hazard to the users and public. These requirements will affect approximately 69,000 holders of or applicants for general licenses for the possession and use of byproduct material in certain items.

i Section 31.5(c)(4) requires that records be maintained showing that tests for leakage of radioactive materials, proper operation of on-off mechanism and/or i

other specified tests have been performed. Many of the devices require testing 1

r for leakage, proper operation of the on-off mechanism and indicator, and installation, servicing, and removal from installation in accordance with instructions on the label or by a person holding a specific license to perform such activities. The records are used by NRC inspectors to determine that there has been compliance with these requirements.

Section 31.5(c)(5) requires that any person possessing a device under the general license in 10 CFR Part 31 shall report, within 30 days, to the Director of the appropriate NRC Regional Office, the occurrence of a failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie or more of removable radioactive material.

In the event that there is occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie or more of removable radioactive material, a general licensee is required to make a report to the Director of the appropriate t!RC Inspection and Enforcement Regional Office. The report must contain a brief description of the event and the remedial action taken.

l The reporting requirement in Section 31.5(c)(5) is necessary to assure that the NRC is notified of any problems or potential problems with devices held under general license.

It is important that the NRC receive such reports to determine if damage or failure of a device could or did constitute a radiation safety problem and to determine that the remedial action taken was appropriate.

These reports also provide experience data which could assist in identifying a generic problem.

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i Section 31.5(c)(8) requires that any person transferring a device to a specific licensee shall, within 30 days after such transfer, furnish to the Director of Nuclear Naterial Safety and Safeguards, a report containing identification of the device and the name and address of the person receiving the device.

If a general licensee disposes of a device, Section 31.5(c)(8) requires a report of the transfer.

The report must identify the device transferred and the name and address of the person receiving the device. Such reports are e

needed so that determination can be made that the transfer of a device was to a person specifically licensed to receive the device.

Such reports also assist in determining when devices are removed from service at a particular location.

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Section 31.5(c)(9) requires that a person transferring the device to another general licensee under specified circumstances shall give the transferee a copy of Section 31.5 and any safety documents identified in the label of the device, and shall report to the Director of Nuclear Material Safety and Safeguards the manufacturer's name and model nunber of the device, the name and address of the transferee,and the name and/or position of the individual who may constitute a point of contact between the Consnission and the transferee. This report is the 1

only mechanism available for making the NRC aware that a particular general licensee is no longer responsible for a device at a particular location and that a different person is responsible for the device.

Section 31.8(c)(2) requires that a licensee shall not receive, possess, use or transfer a generally licensed calibration or reference source unless it bears a label which indicates the model number, serial numbers and caution radioactive material warning notation. This requirement ensures that if a source is lost 3

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or damaged it can be identified by one not having training in radiation l

protection as a radioactive device and also can specifically identify it to the owner or the NRC.

Spction 31.11(b) requires a physician receiving, possessing, using or trans-ferring byproduct material pursuant to the general license established in Sec-tion 35.31(a)tofileNRCForm483,"RegistrationCertificate-InVitroTesting i

With Byproduct Material Under General License." The physician will receive a validated copy back f rom NRC with a registration number assigned. Suppliers of byproduct material to other persons are required to determide that the person receiving the material is authorized to receive it. The validated registration certificate serves as evidence for the supplier that a physician is a general licensee authorized to receive the byproduct material.

Section 31.11(e) requires the registrant to report any changes to the informa-tion furnished on NRC Form 483 within 30 days.

The NRC staff uses the information submitted on the registration form to ident-ify each physician using byproduct material under the general license. The l

certificate also contains the terms and conditions of the general license and assures that the general licensee is aware of terms and conditions prior to receipt of byproduct material and facilitates communication with the general licensee.

l NRC Form 483 has previously been cleared under OMB No. 3150-0038, which should be referred to for additional supporting information, burden and cost data.

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e Reduction of Burden Through Information Technology There are no legal obstacles to reducing the burden associated with this information collection. However, because of the types of information and the infrequency of submission, the registration certificates and reports do not lend themselves readily to the use of automated information technology for submission.

Effort to Identify Duplication The Information Requirements Control Automated System (IRCAS) was searched to determine duplication. None was found.

Effort to Use Similar Information There is no similar information available to the NRC.

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Effort to Reduce Small Business Burden i

The majority of licensees who use byproduct material are small businesses.

Since the health and safety consequences of improper handling or use of radioactive byproduct material are the same for large and small entities, it is not possible to reduce the burden on small businesses by less frequent or less complete accounting or control procedures.

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Consequences of Less frequent Collection Required reports are collected and evaluated on a continuing basis as events l

occur. The schedule for collecting the information is the minimum frequency l

which will permit NRC to assure that the public health and safety are acequately protected.

Circumstances Which Justify Variation from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(b), certain sections of Part 31 require that licensees submit reports to the NRC within 30 days.

Section 31.5(c)(5) requires a report of the failure of or damage to the shielding or the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie or more of removable radioactive material.

This requirement is needed to permit NRC to promptly determine whether the damage or failure may pose a radiation safety problem and whether i

appropriate remedial action has been taken.

Section 31.5(c)(8) requires a report of the transfer of a device to a specific licensee. This requirement is necessary to permit the NRC to determine that the transfer was to a person specifically authorized by NRC to receive the device. Receipt of radioactive material by an unauthorized person could pose a threat to public health and safety.

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h Section 31.11(e) requires the registrant to report any changes to the registration information furnished to NRC on Form 483 within 30 days.

This requirement is needed to keep NRC apprised of the location and status of general licensees so that the agency may contact them promptly in the event that it becomes necessary in connection with radiation safety matters.

Consultations Outside the Agency There have been no outside consultations since the previous clearance.

Confidentiality of Information None, except for proprietary information.

Sensitive Questions None.

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t Estimate of Compliance Burden Reporting Requirements Licensee l

No. of Licensee Staff Hours Total Annual Section Responses Annually Per Submittal Licensee Burden (hrs) f 31.5(c)(5) 3 3

9 31.5(c)(8) 500 0.5 250 t

l 31.5(c)(9) 50 0.5 25 31.8(c)(2) 100 0.15 15 31.11(b)

See OMB Clearance No. 3150-0038 31.11(e)

See OMB Clearance No. 3150-0038 Total:

653 299 l

I Recordkeeping Requirements Total Reccrd l

No. of Annual Hours per Recordkeeping Retention Section Recordkeepers Recordkeeper Mcurs Period 31.5(c)(4) 5,000 0.10 500 3 years Total Nueber of Recordkeepers 5,000 Total Recordkeeping Hours Annually 500 l

Total Annual Burden Hours

_799 l

1 8

.....c...

Estimated Cost to Public to Respond Section Annual Cost to Respond 31.5(c)(4)

$47,500 31.5(c)(5) 855 i

31.5(c)(8) 23,750 31.5(c)(9) 2,375 31.8(c)(2) 1,425 31.11(b)

See OMB Clearance No. 3150-0038 31.11(e)

See OMB Clearance No. 3150-0038 Total:

$75,905 Source of Burden and Cost Data and Method of Estimating Burden and Cost The estimates are based on submittals to NRC in past years.

Cost to licensees and applicants is calculated at a rate of $95 per hour. This figure includes

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both salaries and overhead, i

Estimate of Cost to the Federal Government Application review activities are attributable to and reported under NRC Form 483, OMB Clearance No. 3150-0038. The estimate cost of NRC professional review and other efforts other than those attributable to NRC Form 483 is 33,876.

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