ML20198R117

Notice of Pending NRC Action to Submit Info Collection Request to OMB & Solicitation of Public Comment Re 10CFR31, General Domestic Licenses for Byproduct Matl. Current OMB Approval number:3150-0016

ML20198R117
Person / Time
Issue date:	12/31/1998
From:	Shelton B NRC
To:
References
NUDOCS 9901080096
Download: ML20198R117 (13)

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[7590-01-P]

l U. S. NUCLEAR REGULATORY COMMISSION I

l Agency Information Collection Activities: Proposed Collection; Comment request AGENCY: U. G. Nuclear Regulatory Commission (NRC) l ACTION: Notice of pending NRC action to submit an information collection request to OMB l

and solicitation of public comment. .

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SUMMARY

The NRC is preparing a submittal to OMB for review of continued approval of l

information collections under the provisions of the Paperwork Reduction Act of 1*

l l 1995 (44 U.S.C. Chapter 35).

i information pertaining to the requirement to be submitted:

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1. The title of the information collection: .p 10 CFR 31, General Domestic Licenses for By? aduct Material i

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2. Current OMB approval number: 3150-0016 l

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i 3. How often the collection is required: Reports are submitted as events occur.

Registration certificates may be submitted at any time. Changes to the information on the registration certificate are submitted as they occur.

9901000096 981231 PDR ORO EUSOMB PDR h /t P y xtn . t Ab

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4. Who is required or asked to report: Persons receiving, possessing, using, or transferring byproduct material in certain items.

5. The number of annual respondents: Approximately 10,126 NRC general licensees and 20,252 Agreement State generallicensees.

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6. The number of hours needed annually to complete the requirement or request: 2,634 hours0.00734 days <br />0.176 hours <br />0.00105 weeks <br />2.41237e-4 months <br /> for NRC licensees and 5,265 hours0.00307 days <br />0.0736 hours <br />4.381614e-4 weeks <br />1.008325e-4 months <br /> for Agreement State licensees.

7. Abstract: 10 CFR Part 31 establishes general licenses for the possession and use of byproduct materialin certain items and a generallicense for 1

ownership of byproduct material. Generallicensees are required to keep l l

records and submit reports identified in Part 31 in order for NRC to determine with reasonable assurance that devices are operated safely and I

without radiological hazard to users or the public.

Submit, by (insert date 60 days after publication in the Federal Reaister), comments that )

address the following questions:

1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?

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2. Is the burden estimate accurate?

3. Is there a way to enhan:;e the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information l

technology?

A copy of the draft supporting statement may be viewed free of charge at the NRC Public Document Room,2120 L Street, NW (lower level), Washington, DC. OMB clearance requests are available at the NRC worldwide web site (http://www.nrc. gov /NRC/PUBLIC/OMB/index.html). The document will be available on the NRC home page site for 60 days after the signature date of this notice.

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. Comments and questions about the information collection requirements may be directed to the -

NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 F33, Washington, DC,20555-0001, or by telephone at 301-415-7233, or by Internet electronic mail

. at BJS1@NRC. GOV.

J l Dated at Rockville, Maryland, this 5 /fA day of ado ./... 1998.

L For the Nuclear Regulatory Commission.

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Brenda'JosShelton, NRC Clearance Officer Office of the Chief Information Officer i

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Comments and questions about the information collection requirements may be directed to the NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 F33, <

Washington, DC,20555-0001, or by telephone at 301-415-7233, or by Internet electronic mail at BJS1@NRC. GOV.

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Dated at Rockville, Maryland, this day of 1998.

For the Nuclear Regulatory Commission.

i Brenda Jo. Shelton, NRC Clearance Officer Office of the Chief information Officer i

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1 DOCUMENT NAME: A \FRN1_31.OMB

• See previous concurrence

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OFFICE: RGB , MSB / MSB ,_r OClO NAME: FCardile k LCamper BShelton DATE: 11 /lI/98 frI98 INb 9 /$/ /98 OFFICIAL RECORD COPY l

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DRAFT OMB SUPPORTING STATEMENT FOR 10 CFR PART 31 GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL (3150-0016)

EXTENSION REQUEST Descriotion of the information Collection Part 31 of Title 10 of the Code of Federal Regulations establishes general licenses for certain types of activities. The terms and conditions of the generallicenses require that records must be kept by the generallicensees and/or the general licensees must submit reports to the NRC.

These requirements will affect approximately 39,911 holders of generallicenses for the possession and use of byproduct materialin certain items.

A. JUSTIFICATION

1. Need for and Practicel Utility of the C_p.J!gqtion of information Section 31.2 establishes the terms and conditions of the generallicenses 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 Office of Management and Budget (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 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 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.

Section 31.5(c)(4) requires that the general licensee maintain records showing that tests for leakapa 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 installation, servicing, and removal from installation i in accordance with instructions on the label or by a person holding a specific license to perform i

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l such activities. The records must contain the result of the tests, the date the tests were l performed, and the namer of the individuals performing the tests and must be maintained for 3 years or until the device is disposed of. The records are used by NRC inspectors to l determine that there has been compliance with the requirements of the generallicense.

Section 31.5fc)(5) requires that the generallicensee report, within 30 days, to the Administrator 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.

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 1 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 l the device. These reports are necessary so that the NRC can make a determination that the l transfer of a device was to a person specifically licensed to receive the device. Such reports j also assist in determining when 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 generallicensee 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 a l 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.

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 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 generallicense, and contain the model number and serial number. This

requirement is necessary because it is the only means the Commission has to inform anyone l who may come in contact with the calibration or reference source what they are and their model l and serial number in the event they are lost and need to be identified.

Section 31.11(b) requires a physician receiving, possessing, using or transferring byproduct materialin accordance with the generallicense in Section 31.8 to file NRC Form 483, j " Registration Certificate--In Vitro Testing With Byproduct Material Under General License." The j 2 l

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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 l determine that the person receiving the material is authorized to receive it. The validated j 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 generallicense and assures that the generallicensee 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 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.vithin 30 days. The NRC staff uses the information submitted on the registration form to identify each physician using byproduct material under the general license. The registration information facilitates communication with the general i 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.

2. Aaency Use of Information The records required by Section 31.5(c)(4) are used by NRC inspectors to determine that there ,

has been compliance with the requirements of the generallicense. It is important that NRC receive reports required by Section 31.5(c)(5) so that NRC may determine if damage or failure of a device could or did constitute a radiation safety problem and to determine if remedial action taken was appropriate. Other reports required by the regulation are important so that NRC can determine that the transfer of a device is to a person specifically licensed to receive the device, l to assist in determining when a device is removed from a particular location, and for determining when a general licensee is no longer responsible for the device. The requirements in Section 31.8(c)(2) are necessary so that, in the event of a lost source, the NRC can provide information about the source to anyone who comes in contact with the source.

3. Reduction of Burden Throuah 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. Consequently, the percentage of electronic submissions is zero.

4. Effort to Identify Duolication and Use Similar information The Information Requirements Control Automated System was searched to determine duplication. None was found. There is no similar information available to the NRC.

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l 5. Effort to Reduce Small Business Burden l

While a number of the licensees are considered small businesses, under the NRC's current definitions, the health and safety consequences of improper use of radioactive material are the same for large and small entities. Therefore, it is not possible to reduce the burden on small businesses by less frequent submission or less complete applications.

6. Conseauences to Federal Proaram or Poliev Activities if the Collection is Not Conducted or I

is Conducted Less Freouentiv 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.

7. Circumstances Which Justifv Variation from OMB Guidelines There are no variations from OMB guidelines.

8. Consultations Outside NRC An opportunity to comment on the information collection requirements for this clearance extension has been published in the E.ederal Reaister.

9. Payment or Gifts to Resoondents Not applicable.

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10. Confidentiality of Information None, except for proprietary information.

11. Justification for Sensitive Questions No sensitive information is requested under these regulations.

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12. ' Estimated Purden and B.urden Hour Cost I

i NRC Licensees 1 I

Recordkeeoina Reauirements i Total Record No. of Annual Hours per Recordkeeping Retention Section Recordkeeoers Recordkeeoer Hours Period 31.5(c)(4) - 10,126 0.25 2,532 3 years I Reoortina Reauirements Licensee

No. of Licensee Staff Hours - Total Annual L

Section Resoonses Annually Per Submittal Licensee Burden (hrs) l F

31.2 - See the following OMB Clearances

. 10 CFR Part OMB Clearance No.-

l 19 3150-0044 .,

l- 20 3150-0014 L 21 3150-0035-  ;

30 3150-0017 )

31.5(c)(5) 20 1 20 l

l .31.5(c)(8) 115 0.5 58 i

31.5(c)(9) 29 0.75 22 31.8'c)(2) 6 0.25 1.5 31.11(b) - See OMB Clearance No. 3150-0038 l-l 31.11(e) - See OMB Clearance No. 3150-0038 Total: 170 102

[. Total Annual Burden Hours: 2,634 hours0.00734 days <br />0.176 hours <br />0.00105 weeks <br />2.41237e-4 months <br /> I (recordkeeping and reporting) r 5

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Aareement State Licensees:

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l' NRC estimates that Agreement States have twice as many licensees as does NRC. The NRC has assumed that the amount of licensee staff hours and cost will be the same as for NRC licensees.

l Recordkeeoino Reauirements Total Record No. of Annual Hours per Recordkeeping Retention Section Recordkeeoers Recordkeeper Hours Egig_ct 31.5(c)(4) 20,252 0.25 5,063 ' 3 years Reoortina Reauirements j

. Licensee No. of Licensee Staff Hours Total Annual l Section Resoonses Annually Per Submittal Licensee Burden (hrs) 31.2 See the following OMB Clearances 10 CFR Pari- OMB Clearance No.

19 3150-0044 20 3150-0014 21 3150-0035 30 3150-0017 l

31.5(c)(5) 40 1 40 31.5(c)(8) 230 0.5 115 1

31.5(c)(9) 58 0.75 44

31.8(c)(2) 12 0.25 3 I

i 31.11(b) - See OMB Clearance No. 3150-0038 l

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

l Total: 340 202 i

Total Annual Burden Hours: 5,265 (recordkeeping and reporting) i 4

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l l-Based on the total annual burden hours for recordkeeping and reporting, the total annual cost to l licensees to respond (based on a charge rate of $121/hr)is:

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! 31,5(c)(4) $306,372 $612,744 31.5(c)(5) $2,420 $4,840 31.5(.,(8) $7,018 $14,036 f

31.5(c)(9) $2,662 $5,324 31.8(c)(2) $110 $220 l

(@ $49/hr clerical rate) (@ $49/hr clerical rate) h 31.11(b) See OMB Clearance No. 3150-0038

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

Total: $318,582 $637,164 L

13. Estimate of Other Additional Costs L None.

14. Estimated Annualized Cost to the Federal Government The NRC staff time and associated burden for the requirements of Section 31.2 are included in

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 $121/hr = $4,820. This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.

15. ' Reason for Change in Burden or Cost

There is no change in burden. There is a small change in cost to reflect the difference in the staff hourly rate.

16. Publication for S.atistical Use None.

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17. Reason for Not Disolaving the Exoiration Date The requirement is contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become out of date, would confuse the

.public.

18. Exceotions to the Certification Statement None.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Statistical methods are not used in this collection of information.

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