ML20035H517
| ML20035H517 | |
| Person / Time | |
|---|---|
| Issue date: | 04/28/1993 |
| From: | Crawford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| To: | |
| References | |
| OMB-3150-0016, OMB-3150-16, NUDOCS 9305050188 | |
| Download: ML20035H517 (10) | |
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.tc w ?* w-r :;; w Request for DMB Revie'wt(h)4 pr,,
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Important Re at instructions before completing forrn Do not use the same Sr 83 Send three topies of this furm, the material to be reviewed, and for to recsest botn an Executive O* der 12291 review and approval under paperwork-three copies of tne supporting statement. to the Paperwork Reduction Act Answer an avestions m Pa t 1. If this request is for review under E O.
Office of information and Regulatory Attairs 122M comotete Pa t !! and sign the regulatory ce tification 11 this Office of Management and Bucget recuest ts for approval under the Paperwork Reduction Act and 5 CFR Attention-Docket Library, Room 3201 132D shp Part 11, complete Part til and sign the paperworA certification Washingtrin. DC 20503 PART l.-Complete This Part for All Requests.
- 1. Depe tmert agency anc bateau /ottice onginating request
- 2. Agency coce U. S. Nuclear Regulatory Commission o;;5 3 1 5 0 y
4 bame of pe son who can best answer Questions regarcing tNs reqJest Telephone number s
( 301 >504-2689 4 T 6e o' m'o -r.ation cohection or ruiemasung 10 CFR Part 31 - General Domestic Licenses for Byproduct Material t teg a ros to ew.ut,an co;.ectmn or u>e tcae vnded $tates Cooe. Pubhc Lam. O'Decutwe Drcer)
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S @ Federat agenc+es or empioyees 1 C inewcas or housenotes 3 C Farms 6 @ Non pecht institutions 2 [ State or loca; revernments 4 3 Busmesses or other fo proht 7 @ Sman businesses or o gawations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291
- 7. RetWatson loentif ter Number (R N)
_. o'. None assigned U
- 8. T ype o'submisson Icnets one m eac h ca.egon)
Type of reverw requested Ccssthcstoon State of development 3 C stancerc 1 LJ Ma0-1 L I Proposed or d aft 2 C Pend:ng 2 C temato, 2 O rmaior mtenmf na' wrthono p opsat 3 C f.me gency 3 C rna: or intenm foa' witno f poor pro:csa!
4 C statsto*y or sudet:al deschne 9.Cra se: t.or, a*f ectec CrR _
- 10. Does tv euztion contam reportmg or record *eepq reweme-*r that recare Ot/B approvat under the Paperwos Reduction Act and S CF R O20)
C ves C No n
- 31. ide majo tute is the e a reputa*o y mpact ra'ys:s e". ached' 1 L J Yes 2 La No it"No " ed Of/B wne tne ar.a*ys.s' 3 C ves 4 C No C;rtification for Regulatory Submissions in sabmittar tros reosest f or Of/B reven.the ast$orced regulatory coctact and the p og am o*hcial ce toy that the reavirements of E O 12291 anc any epphcabie ponty directwes t. ave t>eer comphec e Sentre c+ prog am o+hc.a!
' Date bretse o autno zed regJatory contact Date
- 12. TOME, use only)
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- 13. Abstract-Describe needs, uses and afiected pubbe in 50 worcs 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. Tpe cf r W 'ata" a ect on icheck only one) information ccHections not containedin rules 1 C Peg.ar samss:en 2 [ ETe gercy soon ss,on icert;f.ceBon amhed)
Information collections cordamedin tubes 3 ] Ex,stmg egmat on < nc cna ge proposec) 6 F] or -ter m ba: +tneut pror NFCM 7 Eraer date of expected cr actuat Fecerat 4,_, Net.ce c ; coosec et e cerg [NPDM)
A O Pegiar dssion peg. ster pubucation at this stage d rute r.aeg 4
5 L Feat *.F't.1 *as pre.tcmsty pasmec B U Emergency sarmss.on (cer%cano, a~acnec)
(month. car, rear)
- 15. Type of eee* *ea.esies (cr eck oty o e) i L J New couect:on 4 !_'
Remstatement of a previously approved col.ect.on for Ach approval 2 3 Pevton ct a r.r*Ty apprcwed conetton as ewed 3 U Exter s.cn of te ecrat.on cate of a currently approved to:iect<cr
- I Erstmg conect<cn m use wrthout an OMB controt number wecct any ea ge m t~e sut-stance or m tae metnod of corec%on
- 16. Agency recc't *orm nroe"s)(maace stanca'd. optionat form nu n=er(s))
I 22. Purpose of niorrnat on conect,on (checn as snany as apply)
N/A 1 C_ Appocat4on for berents 2 J P egran evaluat.on
- 17. Annua! coc" rg or d sces. e Durcen l
3 ] 3,r,,ai purpose statistics 75'000 i
4 EX Regntary or compance 1 New af responcerts.
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t g o.y,,.,,1,nnmg o,,n.n,,,m,n, 2 fuder s responses per responce-t l
276 n
3 Total an uat resporses (hne 1 hmes.me 2) 6 _ Pesearen 0.58 7 0 a e-t i
a noesperresponse u
s Tetews ce 3 res -e 4; 159
'13. Annual recordkeepmg burcen
- 23. f requency of recor0 keep ng or reporting (checA allthat 8009) i 1 Numoer of recoceepers 12a000 13 neco.dxceping 2 Annual nours per ecor$eeper.
O.25 nepor.jeg i
3 Tctai recoroceperg nours (hse 1 tres one 2) 3.000 2 3 on occasien 4 Record eepmg 'etemon penod 3 years 3 0 weeu,
- 19. Tota! ann ai D.ccen 4 C Ver?.ty 1 Requested (Ime 17-5 plus hne 18 3).
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2 m cyrent CV9 mve-tory 3 D "ecente (nne i ess we 2)
+ 2 360
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frplanation of differeaca 8 U B>enn.aHy 4 Progra n cvge 9 C 0+ber(cescnber 5 Ac,usvert.
+240 i
- 20. Cu rent (rnost recent) CMS controi number or comment number i 24 f. Pespordents' odhgation to coreply (check the strongest ca 3150-0016 2 O vuta<y j
- 21. Requestea exoivaton date 2 U Fequired to obtain or retain a benefit 3_ years from approval' date 3 Ei Mancatn
- 25. are tne respondenn pnrnardy educatmal agencies or mstitut ons or rs t e pnrnary purpose of the conection related to Feoeraf education programs? O Yes E No
- 26. Does me agency use samporg to select respondents or does the egency ecom end or :* esc'te the use of samphng or statistical analysis c.,
Dy esporcerts?
. C Ycs b No
- 27. Feguiatory a iner.ty for t"e mtormadon conection 10 cpn Part_31
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- or. ctner (spec,fy>
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SUPPORTING STATEMENT FOR 10 CFR PART 31 GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL (3150-0016) i EXTENSION REQUEST Description of the Information Collection NRC is requesting the extension of a previously approved information collection. The information collection burden is being adjusted upward to reflect an increase in the number of general licensees.
10 CFR Part 31 establishes general licenses for certain types of activities.
The terms and conditions of the general licenses require that records must be kept by the general licensees and/or the general licensees must submit reports i
to the NRC. These requirements will affect approximately 75,000 holders of general licenses for the possession and use of byproduct material in certain items.
A.
.lustification Need for and Aaency Use of the Information Collection
.Section 31.2 establishes the terms and conditions of the general licenses issued pursuant to Sections 31.3, 31.5, 31.6, 31.7, 31.8, 31.9, 31.10, and 31.11 of this Part. These terms and conditions include certain requirements in 10 CFR Parts 19, 20, 21, and 30. Those requirements have previously been cleared by OMB and the appropriate OMB clearance documents, listed below, should be referred to for additional supporting information, burden and cost data.
10 CFR Part OMB Clearance No.
19 3150-0044 20 3150-0014 21 3150-0035 3
30 3150-0017 Section 31.5 establishes the requirements for a general license for certain measuring, gauging, or controlling devices. The devices contain radioactive byproduct material and are designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere. The devices are distributed to the general licensees by persons licensed in accordance with Section 32.51 and are manufactured under strict quality J
control standards and prototype testing..These controls provide reasonable l
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.
l Saction 31.5fc)(4) requires that the general licensee maintain records showing i
that tests for leakage of radioactive materials, proper operation of on-off mechanism, and/or other specified tests have been performed. Many of the I
devices require testing 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 l
license to perform such activities. The records must contain the result of the tests, the date the tests were performed, and the names of the individuals performing the tests and must be maintained for three 'vars or until the device is disposed of. The records are used by NRC irapectors to determine that there has been compliance with the requirements of the general license.
Section 31.5(c)(5) requires that the general licensee 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 on the generally licensed device, or upon the detection of 0.005 microcurie or more of removable radioactive material.
The report must contain a brief description of the event and the remedial action taken. This reporting requirement is necessary to assure that the NRC is notified of any problems or potential problems with devices held under a 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.
i Section 31.5(c)(8) requires the general licensee to transfer or dispose of a generally licensed device only by transfer to a specific licensee.
Upon transfer, the general licensee shall, within 30 days after such transfer, furnish to the Director of Nuclear Material Safety and Safeguards, a report containing identification of the device and the name and address of the person receiving the device.
These reports are necessary so that NRC can make a determination that the transfer of a device was to a person specifically licensed to receive the device.
Such reports also assist in determining when i
devices are removed from service at a particular location.
Section 31.5(c)(9) requires the general licensee wishing to transfer a device to another general licensee to do so only under certain circumstances and the general licensee is required to give the transferee a copy of Section 31.5 and any safety documents identified in the label of the device.
In addition, the general licensee shall report to the Director of Nuclear Material Safety and i
Safeguards the manufacturer's name and model number 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 Commission a'id the transferee. This report is the only mechanism available for making the NRC
]
aware that a particular general licensee is no longer responsible for a device i
at a particular location and that a different person is responsible for the device.
Section 31.8(c)(2) requires that persons generally licensed in accordance with Section 31.8 shall not receive, possess, use or transfer a generally licensed
.1 americium-241 calibration or reference source unless it bears a label which contains sufficient information relative to safe use and storage of the source, identification that receipt, possession,. use, and transfer of. the source are subject to a general license, and contain the model _ number and serial number. This requirement is necessary because it is the only means the Commission has to inform anyone who may come in contact with the calibration or reference source what they are and their model and serial number in the event they are lost and need to be identified.
2 l
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1 Section 31.11(b) requires a physician receiving, possessing, using or transferring byproduct material in accordance with the general license in Sec-tion 31.8 to file NRC Form 483, " Registration Certificate--In Vitro Testing With Byproduct Material Under General License." The physician will receive a validated copy back from NRC with a registration number assigned. This requirement is necessary because suppliers of byproduct material are required to determine 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. The 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. NRC Form 483 has previously been cleared under OMB No. 3150-0038, which should be referred to l
for additional supporting information, burden and cost data.
Section 31.11(e) requires a physician receiving, possessing, using or transferring byproduct material in accordance with the general license in Section 31.8 to report any changes to the information furnished on NRC Form 483 within 30 days. The NRC staff uses the information submitted on the i
registration form to identify each physician using byproduct material under the general license.
The registration information facilitates communication with the general licensee. 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.
Reduction of Burden Throuah Information Technoloav r
There are no legal obstacles to reducing the burden associated with this t
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.
l Effort to Use Similar Information There is no similar information available to the NRC.
Effort to Reduce Small Business Burden 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 -
I less complete accounting or control procedures.
l Consecuences of less frecuent Collection Required reports are collected and evaluated on a continuing basis as events occur. The schedule for collecting the information is the minimum frequency 3
which will permit NRC to assure that the public health and safety are adequately protected.
Circumstances Which Justify Variation from OMB Guidelines There are no variations from OMB guidelines.
l Consultations Outside the Acency There have been no outside consultations since the previous clearance.
Confidentiality of information None, except for proprietary information.
Sensitive Questions None.
Estimate of Compliance Burden Reportina Reauirements Licensee No. of Licensee Staff Hours Total Annual Section Responses Annually Per Submittal Licensee Burden (hrs) 31.2
- See the following OMB Clearances 10 CFR Part OMB Clearance No.
19 3150-0044 20 3150-0014 i
21 3150-0035 30 3150-0017 31.5(c)(5) 20 1
20 31.5(c)(8) 200 0.5 100 31.5(c)(9) 50 0.75 37.5 j
31.8(c)(2) 6 0.25 1.5 31.ll(b)
- See OMB Clearance No. 3150-0038
)
31.ll(e)
- See OMB Clearance No. 3150-0038 1
Total:
276' 159 j
.)
i I
4
Recordkeepino Reouirements Total Record No. of Annual Hours per Recordkeeping Retenti.,n Section Recordkeepers Recordkeeper Hours Perid_
31.5(c)(4) 12,000 0.25 3,000 3 year; Total Number of Recordkeepers:
12,000 Total Recordkeeping Hours Annually:
3,000 Total Annual Burden Hours:
3,159 Estimated Cost to Public to Respond 9
Section Annual Cost to Respond 31.5(c)(4)
$369,000.00 31.5(c)(5)
$2,460.00 31.5(c)(8)
$12,300.00 31.5(c)(9)
$4,612.50 31.8(c)(2)
$94.50 (0 $63/hr - clerical rate) 31.ll(b)
See OMB Clearance No. 3150-0038 31.11(e)
See OMB Clearance No. 3150-0038 Total:
$388,467.00 Estimate of Cost to the Federal Government The NRC staff time and associated burden for the requirements of Section 31.2 are included the OMB clearance for the appropriate Sections of Parts 19, 20, 21, and 30. Application review activities are attributable to and reported under NRC Form 483, OMB Clearance No. 3150-0038. The estimated cost of NRC professional review and other efforts attributable to the other requirements is 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> at $123/hr = $4,920.00.
Reason for Chance in Burden There are two reasons why there is a change in the burden. The first reason i
is that the number of general licensees has increased. This is a result of many specific licensees changing their licenses to general licenses to avoid NRC annual fees.
Since the total number of general licensees who must respond and keep records has increased, the total burden on general licensees has i
increased.
The second reason for the change in total burden is that the NRC has improved its tracking systems and has better estimates on the number of general licensees. Therefore, the number of responses is more accurately reflected.
5
Source of Burden and Cost Data and Method of Estimatino Burden and Cost The estimates are based on submittals to NRC in past years. Cost to licensees I
and applicants is calculated at a rate of $123 per hour for professional staff I
and $63 per hour for clerical staff. These figures include both salaries and overhead.
Publication for Statistical Use None.
B.
Collections of Information Employino Statistical Methods Statistical methods are not used in this collection of information.
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{7590-01]'
j i
NUCLEAR REGULATORY COMMISSION
'I Documents Containing Reporting or Recordkeeping Requirements: Office of Management and Budget Review AGENCY:
Nuclear Regulatory Commission ACTION:
Notice of the Office of Management and Budget review of information collection.
i
SUMMARY
- The Nuclear Regulatory Commission (NRC) has recently submitted to the Office of Management and Budget (OMB) for review the following proposal for the l
collection of information under the provisions of the Paperwork Reduction Act f
of 1980 (44 U.S.C. Chapter 35).
1.
Type of submission, new, revision, or extension:
Revision.
?
2.
The title of the information collection:
P 10 CFR Part 31 - General Domestic Licenses for ' Byproduct Material 3.
The form number if applicable: Not applicable.
i 4.
How often the collection is required:
Reports are submitted as events occur.
i Registration certificates may be submitted at-any time.
Changes to the information on the Registration Certificate are submitted as they occur..
5.
Who will be required or asked to report:
Persons desiring to own byproduct i
material and persons desiring to possess and use byproduct eaterial in cer,tain items.
6.
An estimate of the number of annual responses:
276 I
7.
An estimate of the total number of hours needed annually to complete the.
l requirement or request: 3,159 (An average of 0.58 hours6.712963e-4 days <br />0.0161 hours <br />9.589947e-5 weeks <br />2.2069e-5 months <br /> per response and- 0.25 i
hours per recordkeeper).
[
8.
An indication of whether Section 3504(h), Pub. L.96-511 applies:
l Not applicable.
[
w
2 9.
Abstract:
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. General licensees are required to keep records and submit reports identified in Part 31 in order to permit NRC to determine with reasonable assurance that devices are operated safely and without radiological hazard to users or the public. The revision reflects an increase in burden i
primarily because of an increase in the number of general licensees.
Copies of the submittal may be inspected or obtained for a fee from the NRC Public Document Room, 2120 L Street, N.W. (Lower Level), Washington, DC.
Comments and questions may be directed by mail to the OMB reviewer:
Ronald Minsk Office of Information and Regulatory Affairs (3150-0016)
NE0B-3019 Office of Management and Budget
{
Washington, DC 20503 Comments may also be comunicated by telephone at (202) 395-3084.
The NRC Clearance officer is Brenda Jo. Shelton, (301) 492-8132.
Dated at Bethesda, Maryland, this day of 1993.
For the Nuclear egulatory Comission i
/
Gerald F. Cranford Designated Senior Official for Information Resources Management