ML20127N822

Request for OMB Review & Supporting Statement Re 10CFR30, Domestic Licensing of Byproduct Matl. Estimated Respondent Burden Is 28,283 H

ML20127N822
Person / Time
Issue date:	01/26/1993
From:	Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0017, OMB-3150-17, NUDOCS 9302010089
Download: ML20127N822 (21)

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the Paperwork Reduction Act Answer all quest 4ons in Part 1. If this request is for review under L O. Office of Information and Regulatory Aff airs  ;

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PART l.-Complete This Part for All Requests, lhartert ege<< and UeaaNe orverg ea,est 2. Agncy cooe .

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SUPPORTING STATEMENT FOR 10 CFR PART 30 DOMESTIC LICENSING OF BYPRODUCT MATERIAL (3150-0017)

Description of the Information Collection NRC regulations in 10 CFR Part 30 establish rules applicable to all persons in the United States governing domestic licensing of radioactive byproduct material. The regulations were issued pursuant to the Atomic Energy Act of 1954. Title 11 of the Energy Reorganization Act of 1974, and the National Environmental Policy Act of 1969 (NEPA), all as amended.

A. Justification Need for and Aaency Use of the Information Collection Section 30.9(b) requires that an applicant or licensee notify the Commission of information which the licensee recognizes as having significant implications for the public health and safety or the common defense and security. This requirement applies only to information which is not covered by other reporting or updating requirements. The information must be provided within two working days.

This requirement is necessary because there may be some circumstances in which a licensee possesses some information which could be important to the protection of public health and safety or the common defense and security but which is not otherwise required to be reported. The codification of this full disclosure requirement should not result in significant additional burdens on applicants or licensees. No formal program is required. What is expected is that licensees will maintain a professional attitude toward safety and that if some potential safety information is identified by the licensee, the information will be provided freely and promptly to the NRC so that the agency can evaluate it and act on it if necessary.

Sfction 30.11 provides that the Commission may grant exemptions from the requirements of Parts 30-35 under specified conditions, upon the application of any interested person or or, its own initiative.

Applications under this section are examined by the NRC materials licensing staff to determine whether the requested exemption is authorized by law and whether it will not endanger life or property or the common defense and security, and to determine if it is ctherwise in the pubile interest.

Section 30.15(b) provides that any person who desires to apply byproduct material to, or incorporate it into, certain exempted products, or who desires to initially transfer for sale or distribution such products containing byproduct material, should apply for a specific license pursuant to Section 32.14, with a license provision stating that the product may be distributed by the licensee to persons exempt from the regulations (hereinafter " exempt persons").

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The application is necessary to permit the NRC materials licensing staff to determine whether the proposed use of byproduct material provides adequate protection of public health and safety. The NRC review and the findings therefrom form the basis for NRC licensing decisions.

The application requirements for 10 CFR Section 32.14 have been previously approved by OMB under clearance number 3150-0001, which should be referred to for information collection burden and supporting data.

Section 3 L ISM 1 provides that no person may transfer byproduct material in specified quantities for commercial distribution to exempt persons, except in accordance with a license issued under Section 32.18.

The application is necessary to permit the NRC materials licensing staff to determine whether the proposed use of byproduct material provides adequate protection of public health and safety. The NRC review and the findings therefrom form the basis for NRC licensing decisions.

The application recuirements for 10 CFR Section 32.18 have been previously approved by OMB unter clearance number 3150-0001, which should be referred to for information collection burden and supporting data.

Section 30.19(b) provides that any person who desires to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to transfer such products to exempt persons for use, should apply for a license pursuant to Section 32.22, with a license provision that the product may be transferred to exempt persons.

The application is necessary to permit the NRC materials licensing staff to determine whether the proposed use of byproduct material provides adequate protection of public health and safety. The NRC review and the findings therefrom form the basis for NRC licensing decisions.

The application recuirements for 10 CFR Section 32.22 have been previously approved by OMB uncer clearance number 3150-0001, which should be referred to for information collection burden and supporting data.

Section 30.20(b1 provides that any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products to exempt persons for use, should apply for a license pursuant to Section 32.26, with a license provision that the product may be initially transferred to exempt persons.

The application is necessary to permit the NRC materials licensing staff to determine whether the proposed use of byproduct material provides adequate protection of public health and safety. The NRC review and the findings therefrom form the basis for NRC licensing decisions.

The. application requirements for 10 CFR Section 32.26 have been previously approved by OMB under clearance number 3150-0001, which should be referred to for information collection burden and supporting data,

, Section 30.3P(al provides that applications for specific licenses for byproduct material should be submitted on NRC Form 313, " Application for Material License." The NRC materials licensing staff will review the 2

information submitted on the form 313 to determine whether an applicant for a license has training, experience, equipment, facilities, and procedures for the use of byproduct material that are adequate to protect the public health and safety.

The use of NRC Form 313 has been previously approved by OMB under clearance number 3150-0120, which should be referred to for information collection burden and supporting data.

Section 30.32(b) provides that NRC may require further statements af ter the filing of the application and before expiration of the license to enable NRC to determine whether the application should be granted or denied or whether a license should be modified or revoked. Such additional information is sometimes needed to clarify information submitted in the application, or to rectify deficiencies in proposed or existing programs for protection of the public health and safety, the common defense and security, or the environment.

The additional information submitted is reviewed by various NRC organizational units to assess the adequacy of the applicant's physical plant, procedures and plans for protection of the public health and safety, common defense and security, and the environment. The NRC review and the findings therefrom form the basis for NRC decisions concerning the issuance, modification, or revocation of licenses for byproduct material.

Most of the burden and cost associated with further statements is included in the burden and cost data for submittal of applications on Form 313, and is covered by clearance number 3150-0120, whic1 should be referred to for further burden and cost information. Additional burden may also be imposed occasionally when it is necessary to ask licensees to respond to an urgent request such as a bulletin or brief survey to provide information concerning a critical safety issue.

Section 30.32(f) requires that an application for a license to receive and possess byproduct material for commercial waste disposal by land burial, or for the conduct of any other activity which the Commission determines will significantly affect the quality of the human environment, must be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by an Environmental Report required pursuant to 10 CFR Part 51.

The NRC licensing staff will review the information submitted by applicants to assure that it is complete and to consider and balance alternatives for the project in order to best protect the environment.

Facilities for commercial waste disposal, or other activities covered by this section, are generally large and complex and have the potential to signifi--

cantly affect the quality of the human environment. NRC's consideration of environmental effects and balancing of alternatives for the project, as mandated by the National Environmental Policy Act of 1969, requires the submission by the applicant of a comprehensive and detailed environmental report.

This section refers to and requires the submission of information pursuant to 10 CFR Part 51. The supporting information concerning the collection of the information, the burden imposed on respondents, and cost to the Govermnent, is 3

contained in the Supporting Statement for 10 CFR Part 51, OMB Clearance Number 3150-0021, which should be referred to for further supporting data.

Eection 30.32(a) requires that an application for a specific license to l receive byproduct material in the form of a sealed source or in a device that contains a source must either identify the source or device by manufacturer and model number as registered with the NRC under 132.210 or with an Agreement j State, or contain the radiation safety related information that is identified '

in 632.210. This information is needed by the NRC materials licensing staff. I to determine the adequacy of radiation safety properties of the source and device under the conditions of proposed use. This determination is used to establish that the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property.

The burden and cost data associated with these registrations is included in the clearance information for 10 CFR Part 32, OMB Clearance No. 3150-0001, which should be referred to for further supporting data.

Section 30.34(e)(4.1 permits the Commission to incorporate in any license additional requirements and conditions to require reports and the keeping of records as may be necessary to effectuate the purposes of the Atomic Energy Act and regulations of the Commission.

Although this regulation imposes no paperwork burden itself, it is cited as authority when necessary for the issuance of orders for the modification of licenses. When the issuance of such orders involves the imposition of reporting or recordkeeping requirements, requests for 0MB clearance of the specific information collection requirement are submitted as necessary.

The information is used by the NRC staff to verify that the licensee has performed required action in a complete and timely manner.

Section 30.34(a) requires each licensee preparing technetium-99m radio-pharmaceuticals from molybdenum-99/ technetium-99m generators to test the generator eluates for molybdenum-99 breakthrough in accordance with 10 CFR ,

Part 35, and to maintain records of the test results for three years.

The requirement to maintain the records of test results is necessary to permit the NRC inspection staff to determine that nuclear pharmacy licensees and broad medical licensees have conducted the tests to determine the amount of molybdenum-99 in' technetium-99 radioactive drugs before administration to patients. If excessive molybdenum-99 is present, it would result in unnecessary radiation doses to patients.

Etction 30.34thl requires that a licensee immediately notify the a>propriate NRC Regional Administrator, in writing, following the filing of a aankruptcy petition by or against the licensee or a controlling or affiliate entity. No action is required of a licensee unless and until a petition for bankruptcy is filed.

l This information is needed because a licensee who is experiencing severe

, economic hardship may not be capable of carrying out licensed activities in a l manner which protects public health and safety. In particular, a licensee l involved in bankruptcy proceedings can have problems affecting payment for L proper handling of licensed radioactive material and for decontamination and L

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decommissioning of the licensed facility in a safe manner. Improper materials handling or decontamination activities can lead to spread of contamination throughout a licensee's facility and the potential for dispersion of contaminated material offsite. Financial difficulties can also result in problems affecting the licensee's waste disposal activities.-

The information provided by the notification would be used by the Regional inspection and licensing staff, in consultation with headquarters legal and program staff, to initiate a determination of the need for prompt NRC response or regulatory action in the event of a potential hazard to public health and safety posed by a licensee that does not have the resources to properly secure the licensed material er clean up possible contamination. In addition, prompt notification would allow the Commission to take timely and appro)riate action in a bankruptcy proceeding to seek to have available assets of tie licensee apnlied '.o cover costs of cleanup before funds are disbursed and become unav.H able for cleanup.

Section 30 2 sets forth the requirements for financial assurance and recordkeeping for decommissioning. Sections 30.35 (a) and (b) specify which licensees are required to submit a certification or funding plan. Sections 30.35(c) and (d) specify prescribed amounts required for submittal of a decommissioning funding plan or certification. Section 30.35(e) specifies the content of the funding plan. Section 30.35(f) specifies acceptable methods for providing for financial assurance either through a certification or funding plan. Section 30.35(g) requires that licensees keep records important to the safe and effective decommissioning of the facility until the license is terminated by the Commission.

The records and reports required are necessary for the Commission to determine whether an applicant will be able to carry out the requirements of Section 30.36 which specify that licensed premises must be decontaminated to a level

" suitable for release for unrestricted use" before the license may be terminated. NRC will review the information to ensure that adequate funds will be available to ensure that the applicant will conduct decontamination efforts in a timely manner and minimize exposure of workers to radioactive materials. The information will also be used to ensure that the decontamination efforts will reduce the residual radioactive contamination sufficiently to protect the public health and safety after the site is released for unrestricted use.

SectimLlql specifies procedures for terminating licensee responsibility for nuclear materials and clarifies that a license will continue in effect, with respect to possession of residual radioactive contamination, until the Commission notifies the licensee in writing. The section requires each licensee who does not apply for license reaewal to notify the Commission immediately in writing of its decision not to renew its license and to request 4 termination of the license. The licensee is required to submit appropriate information concerning the disposal of licensed nuclear materials. NRC form 314 is used to collect this information. NRC form 314 has been previously clesred under 0MB No. 3150-0028, which should be referred to for additional supporting information, burden and :ost data. The licensee may also be required to submit a radiation survey report to confirm the absence of radioactive materials or to establish the level of residual radioactive contamination. The licensee must either submit a certification that no detectable radiation was found, or if any was found must, in certain-cases, 5

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l submit a plan for decontamination and a final radiation survey report, for I instance, licensees with nonleaking sealed sources, and some byproduct material licensees with small license possession limits and short half-life radionuclides, may not need to submit a radiation survey report. In such '

cases, the licensee would show that a radiation survey report is not necessary ,

and would submit a certification that there was no detectable radioactive contamination attributable to activities conducted under the license. This certification, together with the information on disposal of nuclear materials (supplied on form 314), is considered the minimum information necessary to establish a record to support a finding that a license can be safely terminated. Approximately 95 licensees under Part 30 requesting termination will submit certifications annually. It is expected that about 85 Part 30 licensees requesting termination would have to submit a radiation survey report. A radiation survey report is necessary to show radiological conditions at the nuclear facility. Radiation survey reports would be similar to those generated during operations.

In those cases in which the radiation survey report indicates that-the levels of residual radioactive contamination are too high for unrestricted release, certain licensees will be required to submit plans for decontamination.

Criteria for submission and approval of decommissioning plans and the content of such plans are specified. Decontamination plans are necessary to enable the NRC staff to review and evaluate safety aspects of the decontamination, it is estimated that approximately 13 part 30 licensees annually may have to submit decontamination plans.

This information is reviewed by the NRC staff to aermit the Commission to determine that there is no significant risk to pu)lic health and safety before a licensee's responsibility for nuclear materials is terminated and a facility is released for unrestricted use, Sections 30.37(a) and 30.38 require that applications for renewal of a license or amendment of a license be filed in accordance with Section 30.32. The burden and cost data for these applications for renewal or amendment have been included in the supporting data for the clearances listed under Section 30.32, supra, which should be referred to for information collection burden and cost data.

Sections 30.41(c) and (di. Section 30.41(c) requires that, before transferring byproduct material to a specific licensee or a general licensee who is required to register prior to receipt, the transferor must-verify that the transferee's license authorizes receipt of the type, form, and quantity of byproduct material to be transferred. Section 30.41(d) specifies methods acceptable to the Commission for accomplishing the required verification, including: +

(1) The transferor may have in his possession, and read, a copy of the-transferee's specific license or .egistration certificate.

(2) The transferor may have a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration number, issuing agency, and expiration date.

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(3) for emergency shipments, the transferor may accept oral certification from the transferee, provided it is confirmed in writing within 10 days.

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or Agreement State licensing agency.

(5) When other methods are not available, the transferor e:./ obtain and record confirmation from the Commission or Agreement State licensing agency.

The information recuired by Sections 30.41(c) and (d) is used by transferring licensees to provice assurance that the licensed byproduct material is being transferred to a person who is authorized to receive it. This verification serves as an additional check to prevent transfer of byproduct material to persons who may not have the facilities, training, experience, equipment, or procedures necessary for the safe handling of the material. Records of these certifications will be reviewed by NRC inspectors during periodic inspections to ensure that licensees have been complying with verification requirements.

Section 30.50 requires licensees to notify NRC immediately (i.e., within four hours) by telephone of events or conditions that threaten the health and safety of individuals using licensed material or that prevent the performance of surveys or other safety-related duties necessary to maintain control over licensed material. Licensees must report contamination events in which access to an area must be rectricted for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> because of contamination.

It is important that NRC be notified in such cases because accidental contamination events increase radiation exposure and the risk of ingesting radioactive material. Licensees will be required to report events in which equipment necessary to prevent uncontrolled releases of radioactive material, to prevent overexposure to radiation, or to mitigate the consequences of an accident is disabled or fails to function as designed. This includes procedural errors, equipment failure, equipment damage, etc. This notification is necessary in situations in which there are no backup systems available to protect public health and safety.- Notification is not required for an individual component failure if redundant systems are operable and available to automatically perform the required function. Licensees will be required to report events that require medical treatment of a radioactively contaminated individual at a medical facility. -Such events are significant because they may: (1) indfcate safety problems in a licensed operation, risk internal contamination through open wounds, and (3) expose medical (2) personnel to radiation and contamination. Prompt notification is necessary so that NRC can ensure that an evaluation is performed and that measures are taken to prevent recurrence. Licensees will also be required to report all fires and explosions involving any device, container, or equipment containing licensed material, so that such events may be promptly evaluated and measures taken to minimize any spread of contamination and determine the performance of features designed to h ntrol licensed material. In addition to the telephone report, licensees must make a written followup report within 30 days which iMludes, in addition to descriptive information, an evaluation of the probable cause and a description of corrective actions taken or planned.

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Section 3Q& establishes overall record retention requirements applicable to byproduct material licensees for cases in which retention periods are not otherwise specified in the regulations.

Section 30.51(a) requires that each licensee who receives byproduct material must keep records showing the receipt, transfer, and disposal of such byproduct material. It provides for retention of records of receipt of byproduct material as long as the material is possessed and for three years following transfer or disposal, provides a three year retention period for records of transfer of byproduct material, and provides that records of disposal of licensed material must be maintained until the Commission terminates the license.

Section 30.51(b) requires that records which are required by the regulations in Parts 30-35 or by license conditions must be maintained for the period specified by the appropriate regulation or license condition. In any case in l which a retention period is not specified, the records must be maintained until the Commission authorizes their disposition.

Records are necessary as a primary source for determination that licensees have confined their possession and use of byproduct material to the locations and purposes authorized in the licenses and have not violated or failed to observe any of the terms and provisions of the Atomic Energy Act or any regulation or order of the Commission. Records of rcceipt can demonstrate that the licensee has received byproduct material of the element and mass number and in the chemical and/or physical form specified in the license.

Records of transfer can demonstrate that the licensee has transferred byproduct material of the type, form, and quantity that transferees are authorized to receive. Records of disposal can demonstrate tnat the licensee has obtained approval of disposal procedures and/or has disposed of byproduct material in accordance with NRC regulations. Records of receipt, transfer, and disposal, taken together, can demonstrate that the licensee has possessed at any one time no more that the maximum quantity of byproduct material authorized in the license. The retention periods provide reasonable assurance that records will be available for Commission inspection after the recorded event.

Section 30.55(c) requires that each person who is authorized to possess tritium shall report promptly to the appropriate NRC Regional Office any incident in which any attempt has been made or is believed to have been made to commit a theft or unlawful diversion of more than 10 curies of such material at any one time or 100 curies of such material in any one calendar year.

The information submitted by licensees under this requirement is used by the Regional Office to determine whether there has been a diversion or other loss of material and to initiate prompt action in the event of such diversion or loss. The written reports submitted to NRC Regional Offices which set forth the details of the incident, its consequences, and any substantive additional information are duplicate copies of reports filed with the Federal Bureau of Investigation on the theft or unlawful diversion of tritium.

Accendix A establishes criteria for parent companies to pass the financial test for issuance of a parent company financial guarantee. It specifies various financial ratios, including net worth and asset / liability ratios, and 8

bond ratings. It requires that the licensee notify NRC within 90 days of any i matters coming to the attention of the independent auditor which cause the  !

auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test. If the parent company no longer meets the financial test requirements, the licensee must send notice to NRC of intent to establish alternate financial assurance as  :

specified in the Commission's regulations. The notice must be sent within 90 days after the end of the fiscal year for which year-end financial data show that the company no longer meets the financial test requirements. The notice is necessary to permit NRC to take action to ensure that alternative means of financial assurance are available for deconrnissioning.

Reduction of Burden Throuah Information Technoloav 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 applications 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. In general, information required by NRC in applications, reports, or records concerning the transfer, receipt, possession, or use of byproduct material does not duplicate other Federal information collection requirements and is not available from any source other than applicants or licensees. Portions of the needed information might also be contained in other information submittals to NRC or other Federal agencies.

However, duplication, if any, is slight, and the collection of this information by use of specified forms and other required reports and records is the most effective and least burdensome means of obtaining the information.

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 l less complete reporting, recordkeeping, or accounting and control procedures.

I Consecuences of less Freouent Collecitan Required reports are collected Tnd evaluated on a continuing basis as events

, occur. Applications for new licanses and amendments are submitted only once.

Applications for renewal of licenses are submitted every five years.

Information submitted in previous applications may be referenced without being resubmitted. The schedule for collecting the information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of the public health and safety.

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Lircumstances Which Justifv Variation from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.9(b) requires that licensees submit a notification to NRC in less than thirty days from the date of identifying information having significant implications for the public health and safety or the common defense and security and which is not covered by other reporting requirements. The requirement to provide notification within two working days following the identification of the information is necessary to ensure that NRC is made aware of the significant safety Infor-mation so as to take prompt effective action to protect the public health and safety.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.34(h) requires that licensees submit a notification to NRC in less than thirty days from the date of filing of a petition in bankruptcy. The requirement to provide notification promptly following the filing of the petition is necessary to ensure that NRC is made aware of the bankruptcy so as to take effective action to protect the public health and safety. Allowing a period of thirty or more days to elapse might preclude NRC from becoming aware of the licensee's distressed financial circumstances in time to prevent the development or aggravation of a potential hazard to the public. Moreover, the United States Code contains requirements regarding notification of creditors in bankruptcy.

Section 30.34(h) would require one additional notification. Notifying NRC promptly after the filing of the petition would in fact be itss of a burden on the bankrupt than a separate notification later in the proceedings.

Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 30.35(g) requires that licensees keep records important to the safe and effective decommissioning of the facility until the license is terminated by the Commission. It is necessary that the records be retained longer than three years so that the Commission may determine whether an applicant will be able to carry out the requirements of Section 30.36 which specify that licensed premises must be decontaminated to a level " suitable for release for unrestricted use" before the license may be terminated. NRC reviews the information to ensure that adequate funds will be available to ensure that the applicant will conduct decontamination efforts in a timely manner and minimize exposure of workers to radioactive materials. The information is also used to ensure that the decontamination efforts will reduce the residual radioactive contamination sufficiently to protect the public health and safety after the site is released for unrestricted use.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.36 requires each licensee who does not apply for license renewal to notify the Commission immediately in writing of its decision not to renew its license and to request termination of the license. This notification in less than 30 days is necessary to permit the NRC staff to determine whether any prompt measures may be needed to ensure that radioactive material is safely transferred or disposed of and that there is no significant risk to public health and safety before a licensee's responsibility for nuclear materials is terminated and a facility is released for unrestricted use.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.50 requires licensees to notify NRC immediately (i.e., within four hours) by telephone of events or conditions that threaten the health and safety of individuals using licensed material or that prevent the performance of surveys or other safety-10 l

- . . - - - - . . -~ - -- - .~ . -. - -

related duties necessary to maintain control over licensed material. It is important that NRC be notified in such cases because accidental contamination events increase radiation exposure and the risk of ingesting radioactive material. Immediate notification is needed so that such events may be promptly evaluated and measures taken to minimize any spread of contamination and determine the performance of features designed to control licensed material.

Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 30.51(a) requires retention of records of receipt of byproduct material as long as the material is possessed and for three years following transfer or disposal, provides a three year retention period for records of transfer of byproduct material, and provides that records of disposal of licensed material must be maintained until the Commission terminates the license. Section 30.51(b) requires that records which are required by the regulations in Parts 30-35 or by license conditions must be maintained for the period specified by the appropriate regulation or license condition. in any case in which a retention period is not specified, the records must be maintained until the Commission authorizes their disposition.

These records are necessary as a primary sour,:e for determination that licensees have confined their possession and use of byproduct msterial to the locations and purposes a'uthorized in the licenses and have not violated or failed to observe any of the terms and provisions of the Atomic Energy Act or any regulation or order of the Commission. Records of receipt can demonstrate that the licensee has received byproduct material of the element and mass number and in the chemical and/or physical form specified in the license.

Records of transfer can demonstrate that the licensee has transferred byproduct material of the type, form, and quantity that transferees are authorized to receive. Records of disposal can deronstrate that the licensee has obtained approval of disposal procedures and/or has disposed of byproduct material in accordance with NRC regulations. Records of receipt, transfer, and disposal, taken together, can demonstrate that the licensee has possessed at any one time no more that the maximum quantity of byproduct material authorized in the license- Retention for longer than three years, where required, is necesr.ary to provide reasonable assurance that records will be available for Commission inspection after the recorded event.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.55(c)_ requires that each person who is authorized to possess tritium shall report promptly to the appropriate NRC Regional Office, by telephone and telegraph, mailgram, or facsimile, any incident in which any attempt has been made or is believed to have been mado to commit a theft or unlawful diversion of more than 10 curies of such material at any one time or 100 curies of such material in any one calendar year. The initial report must be followed within 15 days by a written report setting forth the oetails of the incident and its consequences.

These reports in less than 30 days are necessary to permit the Regional Office to determine whether there has-been a diversion or other loss of material and l to initiate prompt action in the event of such diversion or loss. The written reports submitted to NRC Regional Offices which set forth the details of the incident, its consequences, and any substantive additional information are duplicate copies of reports filed with the Federal Bureau of Investigation on the theft or unlawful diversion of tritium.

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i, Consultations Outside the NRC There have been no consultations outside the agency since the previous clearance of these information collection requirements.

Confidentiality of Information None, except_for proprietary information.

Sensitive Ouestions None.

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n Estimate of Comoliance Burden Reportina Reauirements Licensee Total Annual No. of Licensee Staff Hours Licensee Burden Section- Responses Annually Per Submittal (Hrs) 30.9(b) 10 1 '10 30.11 20 5 100 30.15(b) - See OMB Clearance No. 3150-0001'(10.CFR 632.14) 30.18(d) - See OMB Clearance No. 3150-0001 (10 CFR 932.18) 30.19(b) - See OMB Clearance No. 3150-0001 (10 CFR 932.22) 30.20(b) - See OMB Clearance No. 3150-0001 (10 CFR 532.26).

30.32(a) - See OMB Clearance No. 3150-0120 (NRC Form 313) 30.22(b)

NRC Form 313 - See OMB Clearance No. 3150-0120 Bulletins,~etc. 30 1 10 300 30.32(f) - See OMB Clearance No. 3150-0021 (10 CFR Part 51) 30.32(g) See OMB Clearance No. 3150-0001 (10 CFR 932.210) 30.34(e)(4) - Burden is listed in individual clearance requests submitted as needed.

30.34(g) 58 0.06 3.48 30.34(h) -10 0.5 5.0 <

-30.35 Certification 50 100 5,000-Funding Plan 54 -300 16,200 30.36 NRC Form 314 - See OMB Clearance No. 3150-0028

. Certification 95 1 95 Survey 85 8 680 ,

Decontamination Plan 13' 360 4,680 13

Reportina Recuirements (cnni'd1 30.37(a) - See OMB Clearance No. 3150-0120 30.38 - See OMB Clearance No. 3150-0120 30.50 30 4 120 30.55(c) 0 10 0 Appendix A Review 69 10 690 Certification 1 100 100 Funding Plan 1 300 300 Total Reporting 526 28,283.48 Resu dkeepina Reauirements Annual Hours Total No. of per Recordkeeping Section Recordkeepers Recordkeeogt Hours 30.35 7,100 10.0 71,000 30,41(c) & (d) 7,100' 3.53 25,071 30.51 7,100 3.53 25,071 Total Number of Recordkeepcrs

7,100 Total Record Keeping Hours Annually: 121,142 TOTAL ANNUAL BURDEN HOURS: 149,425 Estimated Cost to Public to Respond Section Annual Cost to Resp _nnd 30.9(b) $950 30.11 $36,900 30.15(b) - See OMB Clearance No. 3150-0001 (10 CFR 532.14) 30.18(d) - See OMB Clearance No. 3150-0001 (10 CFR 532.18).

30.19(b) - See Of18 Clearance No. 3150-0001 (10 CFR 532.22) 30.20(b) - See OMB Clearance No. 3150-0001 (10 CFR S32.26) 14 l

i, Estimated Cost to Public to Resoond (continued)_

lac 1Lqn Annual Cost to'ResDond 30.32(a) - See OMB Clearance No.-3150-0120 (NRC Form-313) i 30.32(b)

NRC Form 313 - See OMB Clearance No. 3150-0120 Bulletins, etc. 17,380 30.32(f) - See OMB Clearance No. 3150-0021 (10 CFR-Part 51) 30.32(g) - See OMB~ Clearance No. 3150-0001 (10 CFR 632.210) 30.34(e)(4) - Cost is listed in individual clearance requests submitted as needed.

30.34(g) $428 30.34(h) $615 30.35 Certification $615,000 Funding Plan 51,992,600 Recordkeeping 58,733,000 30.36 NRC-Form 314 - See OMB Clearance No. 3150-0028 Certification- $11,685 Survey '$83,640-Decontamination Plan $575,640-

-30.37(a) - See OMB Clearance No, 3150-0120

~

30.38 - See OMB Clearance No. 3150-0120 30.41(c) & (d) $3,083,733-30.50 $14,760-15

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Estimated Cost to Public to Respond (continued)

Section. Annual Cost to Respond 30.51 $3,083,733 30.55(c) 0 Appendix A 3134,070 Total $18,374,200 Source of Burden and Cost Data and Method of Estimatino and Cost The estimates are based on submittals to NRC in past years. Cost to licensees and applicants is calculated at a rate of $123.00 per hour. This figure includes both salaries and overhead.

flg.ason for Chance in Burden The revision is a net increase in the burden estimate, primarily as a result of the inclusion of a previously approved rulemaking that added decommissioning financial assurance requirements that are intended to ensure that licensees who receive the benefits from the use of nuclear materials provide a financial surety for remediating contamination when licensed operations cease. That rulemaking added burden in Sections 30.35 and 30.36.

Burden has also been included _for Section 30.50, which was added by_a another_

rulemaking previously approved by OMB. Section 30.50 added requirements for.

immediate notification to NRC of events or conditions that threaten health and safety. Additional burden was also included as a result of a reevaluation of the ime required-to prepare requests for exemption under 30;11, and the burde(n estimate for Section 30.32(b) was raised to account for the-increa number of requests for further information needed, often in the form of-bulletins, in response to urgent safety-related incidents. While those-sections have resulted in added burden, there has been a decrease in the number of licensees under Part 30. The result of these revisions is a net increase in burden of 89,361 hours0.00418 days <br />0.1 hours <br />5.968915e-4 weeks <br />1.373605e-4 months <br />.

Estimate of Cost to the Federal Government-Annual Cost - NRC Staff Review (Professional effort - 3,217 hours0.00251 days <br />0.0603 hours <br />3.587963e-4 weeks <br />8.25685e-5 months <br /> 0$123/hr) = $395,691 for-activities other than application review. Application review activities are attributable to and reported under NRC Form 313, OMB Clearance No. 3150-0120.

Publication for Statistical Use None.

B. Collection of Information Employino Statistical Piethods Statistical methods are not used in-this collection of information.

16

(44

[7590-01]  ;

s NUCLEAR REGULATORY COMMISSION Documents Containing Reporting or Recordkeeping.  ;

Requirements: Office of Management and Budget Review i AGENCY: Nuclear Regulatory Commission ACTION: Notice of the Office of. Management and Budget review of information..

collection.

SUMMARY

The Nuclear Regulatory Commission (NRC)-has recently' submitted to. [

the Office of Management and Budget (OMB) for review the following proposal for the-collection of_ information under ~the provisions of the Paperworkl Reduction ~Act (44 U.S.C. Chapter 35), -

1. Type of submission new, revision, or extension: Revision. [

2. The- title of the informatlon collection:' ,

-10 CFR Part 30 - Domestic = Licensing-of Byproduct Material:

l 3. The form number if. applicable: ~ Not Japplicable. -

4. How often the collection is. required: Required reports are collected andi z

evaluated on a co'ntinuing basis as eventsLoccur. - Applications for new-licenses and amendments are submitted only.once.- Applications for--

- renewal licenses are submitted every five' years. Information submitted in previousL applications _ may be referenced without being resubmitted, 1

5.. Who'will be required'or. asked to report:: Persons applying for orsho_lding6

-a license to manufacture, produce; transfer, receive,nacquire,5own, possess, or use radiopctive byproduct material.

_a t

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. '. ,- .,o v $ .-e.4,w,,- s , vrw...4 + Er y

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6. An estimate of the number of responses: Approximately 5,600-Material License Application responses subject to 10 CFR Part 30 requirements are accounted for separately under the clearance _ previously approved for NRC Form 313, OMB No. 3150-0120, and other clearances. An additional 526 responses are accounted for under this information collection clearance-request.

7. An estimate of the total number of hours needed to complete the _

requirement or request: Approximately 7.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> per Material License Application subject to Part 30, for a total of 42,250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br />, is accounted for separately under the clearance previously approved for NRC Form 313, OMB No. 3150-0120. An additional 53.77 hours8.912037e-4 days <br />0.0214 hours <br />1.273148e-4 weeks <br />2.92985e-5 months <br /> per response and 17.06 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> per recordkeeper, for a total annual industry burden of 149,425-hours, is accounted for under this information collection clearance request.

8. An indication of whether Section 3504(h), Pub. L.96-511 applies: ,

Not applicable. I

9. Abstract: 10 CFR Part 30 establishes requirements governing domestic licensing of radioactive byproduct material. The application, reporting and recordkeeping requirements are necessary to permit the NRC~to make a determination whether the use of byproduct material is in conformance-with the Commission's regulations for protection of the public health and safety. The revision primarily reflects the inclusion of burden imposed by a previously approved rulemaking that added decommissioning financial assurance requirements.

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.

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4 Comments and questions may be directed by mail to the OMB reviewer:

Ronald Hinsk Office of Information and Regulatory Affairs (3150-0017)

NE0B-3019 Office of Management and Budget Washington, DC 20503 Comments may also be communicated by telephone at (202) 395-3084.

The NRC Clearance officer is Brenda Jo Shelton, (301) 492-8132.

f Dated at Bethesda, Maryland, this [ k day 19 [3, For the Nuclear Regulatory Commission 0

ih Gerald F. Cranford Designated Senior Official for Information Resources Management i

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