ML20212C016

Request for OMB Review & Supporting Statement Re 10CFR31, General Domestic Licenses for Byproduct Matl. Estimated Respondent Burden Is 299 H

ML20212C016
Person / Time
Issue date:	02/25/1987
From:	Norry P NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
OMB-3150-0016, OMB-3150-16, NUDOCS 8703030687
Download: ML20212C016 (12)

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Request for OMB Review -

Import:nt ' -

g Send three copies of this form, thimaterral to R;ad instructions before comple ting form. Do not use the same SF 83 13 request both an Executive Order 12291 review and approval under paperwork-threc copies of the supporting statement, to N~

the P:perwork Reduction Act Answer all questions in Part I. If this request is for review under LO. OtfKe of information and Regulatory Af fairs 12291. complete Part 11 and sign the regulatory certification. If this Of fice of Management and Budget request is for approval under the Paperwork Reduction Act and 5 CFR Attention: Docket Library, Room 3201 1320. skip Part il. complete Part lli and sign the paperwork certification. Washington. DC 20503 PART l.-Complete This Part for All Requests.

1. Department / agency and Bureau /of fice origrnating request i 2. Agency code U.S. Nuclear Regulatory Commission 5 0

3. Nime of person who can best answer questions regard.r g this request l3 1 Telephone number Sterling Bell ( 301 > 427-9026

4. Title of information collection or rulemaking 10 CFR Part 31 - General Domestic Licenses for Byproduct Material

5. Legil cuthority for information collection or ruie (cite L/nsted States Code. Public Law, cv Decutive Order) 42 use 2201(o) . o,

6. Affected public (check allthat apply) S @ Federal agencies or employees i O indmouais or househoes a O rarms e @ Non orof,e instit t.ons 2 @ State orlocalgovernments 4 @ Businesses orother for. profit 7 @ Small businesses or organeations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291

7. Regulat.on Identifier Number (RIN)

__ _ ~ _ _. __ _ . or. None assigned

8. Type of submission (check one on each category) Type of review requested Classification stage of development 1 Standard i O uaior i O proposed or draft 2 O eending 2 O Nonmajor 2 O rinaior intenm finai.witn orior p epoui 3 0 cmergency 3 0 renal or intenm final, without pnor proposal 4 b Statutory or gudicialdeadline

9. CFR section affected CrR

10. Does this regulat'en CcCtain reportrg or recufdheeping requirements that require OMB approval under the Paperwork Reduction Act and 5 CFR 1320? - O ves O No

11. If a major ru?e,is there a regulatory impact aralyvs attached? 1 O ves 2 O No itNo," d.d OMB wane the anaps? 3 0 ves a O no Certificction for Regulatory Submissions in submitting this request for OMB review. the authonred regulatory contact and the program off.cial certify that the requirements of E O 12291 and any apphcable poucy d rectnes have been corrphed w*n Signature of program official Date

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Signature of authonied regulatory conta t.~ - - ~ ~'

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Nw mcm ouan 8703030687 870225 s cm imm 12291 PDR ORG EUSOMB PDR 3

SUPPORTING STATEMENT FOR 10 CFR PART 31 GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL Justification Need for and Agency Use of the Information Collection Section 31.5 of 10 CFR Part 31 establishes a general license for certain measur-ing, gauging, or controlling devices. The devices contain byproduct material and are designed and manufactured for the purpose of detecting, measuring, gaug-ing 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, 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 l

safely and without radiological hazard to the users and public.

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

other specified tests have been performed. Many of the devices require testing for leakage, proper operation of the on-off mechanism and indicator, and instal-1

PART lli.-Compi:t]This Part 0:ly if tt a Request is for Appr;vil cf a C:lltcti:n

of Information Under the Paperwork Heduction Act end 5 CFR 1320.

13. Abs;ract-Descnbe needs, uses and affected put he 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.

14. Type of informaten collection (check only one)

Information collections not contained in rules 10 Regular submission 2 O Emergency submission (certsfacatsonattached) 1:. formation collections contained in rules 3 @ Existing regulaton(no change proposed) 6 Fmal or intenm final without pnor NPRM 7. Enter date of expected or actual Federal 4 O Notice of proposed rulemaking(NPRM) A O Regular submission Register pubhcaten at this stage of rulemaking 5 O rinar. NeRu was previousiy pubhshed a O Emersency submission (cert,hcar on attached > (monta dar. rear >:

15. Type cf review requested (check only one) 1 O New coi:ection 4 O Reinstatement of a previously approved collectioni for which approval has expired 2 O Revision of a currentry approved coitection 3 @ Extension of the expiration date of a currently approved collection 5 O Existing collection in use without an oMB control number without any change in the substance or m the method of collection 15 Agency teport form number (s)(include standard /optionalform number (s)) 22. Purpose of information collection (check as many as apply) 1 O Apphcationforbenefits 2 O Programevaluation

17. Annual reporting or disclosure burden 3 0 ceneraipurposestatistics 1 Number of respondents . 69.000 4 5 Reguiatory orcompliance 2 Number of responses per respondent 5 O Program pianning or management 3 Total annual responses (line I times I,ne 2) 6 O Research 4 Hours per response 0.46 7 O Aud't 5 T'tal hours (live 3 times hne 4) 299

18. Annualrecordkeepingburden 23. Frequency of recordkeeping or reporting (Check all that apply) 1 Number of recordkeepers

,000 18 Recordkeeping 2 Annual hours per recordkeeper.

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3 Tott recordkeeping hours (hne i times hne 2; 500 2 8 onoccasion 4 Recordkeepr:g retention penod 2 years 3 0 weekiy

19. Tot:1 annual burden '

jgg 4 O uontnir 1 Requested (hne 17-5 plus hae 18-3) . 5 0 Quarterfy 2 In current oMB mventory 6 0 semi. nnuairy 3 Difference (line lless kne 2) 7 O Annually Esplanation of difference 6 O B.ennially 4 Program change 9 0 otner(desce,be):

5 Adjustroent .

20. Current (most recent)oMB control number of comment number 24. Respondents' obhgation to comply (checA the strongest obhgation thatapphes) 3150-0016 i O voi ntaryu

21. Lequested enpiration date 2 O Required to obta n or retain a benefit 3 years from approval date 3 E Mandatory

25. Ar) the respondents pnmanly educational agencies or institutions or is tne pnmary purpose of the collect on related to Federal educaten programs? O yes 0 No

26. Does the agency use samphng to select respondents or does the agency recommend or prescrte the use of samphng or statistical analysis by respondents? . O yes 0 No authority for the information collection 27.Regulato30 crRPart 31 :or rR  : or.other(specify)-

Paperwork Certification in submittmg this request for oMB approval, the agency head, the senio official or an authonzed representatr e. certifies that the requirements of 5 CFR 1320 the Pnvacy Act, statistical standards or direct'ves, and any other apphcable mformation pohty directwes have bee' c amphed with.

Signitura of prot, ram off.cial Date i

i i signatura of agency head. the sen.or official or an authorized re sentative Date Patricia G. Norry, Director Office of Administration M c[-- J J~h l M GPO : 1984 0 - 453-776

lation, servicing, and removal from installation in accordance with instructions on the label or by a person holding a specific license to perform such activ-ities. 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 indi-cator, or upon the detection of 0.005 microcurie or more of removable radioac-tive 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 l

NRC Inspection and Enforcement Regional Office. The report must contain a brief description of the event and the remedial action taken. The reporting require-ment 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 l

1s 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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Section 31.5(c)(8) requires that any person transferring a device to a specific licensee shall, within 30 days after such trarsfer, 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.

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 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 deter-mining when devices are removed from service at a particular location.

t l 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 i 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 number of the device, the name and address of the transferee,and the name and/or position of the individual who may constitute l

a point of contact between the Commission and 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 at a particular location and that a different person is responsible for the device.

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f l 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 or damaged it can be identified by one not having training in radiation protec-tion as a radioactive device and also can specifically identify it to the owner or the NRC.

Section 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) 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. Suppliers of byproduct material to other persons 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.

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 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 4

receipt of byproduct material and facilitates communication with the general licensee.

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

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 Federal Information Locator System was searched to determine NRC and other Federal agency duplication. None was found.

i 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 I

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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.

Consequences of Less Frequent Collection

' Required reports are collected and evaluated on a continuing basis as events occur. The schedule for collecting the information is the minimum frequency which will permit NRC to assure that the public health and safety are adequately 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 appropriate remedial action has been taken.

4 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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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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Description of the Information Collection Number and Type of Respondents These requirements will affect approximately 69,000 holders of or appli-cants for general licenses for the possession and use of byproduct mate-rial in certain items. .

Record Retention Period

-Section 31.5(c)(4) requires that the licensee maintain records showing the performance of leak tests, on-off mechanism tests, and other specified tests. The regulation currently specifies that the various records be

, retained for periods of one or two years. NRC's planned Record Retention rulemaking will establish a uniform retention period of three years for these records. The records must be available for examination by NRC inspectors to determine whether there has been compliance with the testing requirements.

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n-if Estimate of Compliance Burden Reporting' Requirements' Licensee No. of Licensee Staff Hours Total Annual Section Responses Annually Per Submittal Licensee Burden-(hrs) 31.5(c)(5) 3 3 9 31.5(c)(8) 500 0.5 250

'31.5(c)(9) 50 0.5 25 31.8(c)(2) 100 0.15 -15 31.11(b) See'0MB Clearance No. 3150-0038 31.11(e) See OMB Clearance No. 3150-0038 Total: 653 299 Recordkeeping Requirements Planned Total Record No. of Annual Hours per Recordkeeping Retention Section Recordkeepers Recordkeeper Hours Period 31.5(c)(4) 5,000 0.10 500 3 years Total Number of Recordkeepers 5,000 Total Recordkeeping Hours Annually 500

l Total Annual Burden Hours 799 4

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Estimated Cost'to Public to Respond Section Annual Cost to Respond 31.5(c)(4) $30,000 31.5(c)(5) 540

'31.5(c)(8)- 15,000 31.5(c)(9) 1,500 31.8(c)(2) 900 31.11(b) See OMB Clearance No. 3150-0038

-31.11(e) See OMB Clearance No. 3150-0038 LTotal: $47,940 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 $60 per hour. This figure includes both salaries and overhead.

l 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

$2,654.

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