ML20216F451

Request for OMB Review & Supporting Statement Re 10CFR71, Packaging & Transportation of Radioactive Material. Estimated Respondent Burden to Be 63,537 H

ML20216F451
Person / Time
Issue date:	09/09/1997
From:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20216F421	List: ML20216F416 ML20216F451
References
OMB-3150-0008, OMB-3150-8, NUDOCS 9709110257
Download: ML20216F451 (16)

Text

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o l PAPERWORK REDUCTION ACT SUBMISSION l Please read the instructions before complet ng this form For addtonal form 8 or assistance in completing this form, contact your i

C0ency's Paperwork Clearance Officer. Send two copies of this form the collection Instrument to be feviewed, the Supporting Statement, and any addtonal documentation to Of0ce of Information and Regulatory Affairs, Office of Management and Dudget Docket Library, Room 10t02,72517th Street NW, Washington, DC 20503

1. Agency / Subagency originating request _1 OMB control number U.S. Nuclear Regulatory Commission M a 3150 0008 b None J Type of information collection (check one) J Type of revew requested (check one) _

a New collection X a Regular submissaon c. Delegated b Revis6on of a currentty approved collection b Emergency . Approval requested by (date) c Extension of a currently approved collection 5 Will this informatton cohection have a , ygg sigmficant economic impact on a -

sty approved t se appr h e pr substanttal number of small entites? X b No

~"""

e Reinstatement, with change of a prevlously approved collection for Wh6ch approval bas expired X a Three years from approval date

_ Requested 6 expiration f Existing collection in use without an OMB control number cate

7. Title 10 CFR Part 71,' Packaging and Tfansportation of Radioactive Material" 8 Agency form number (s) (if app 6 cable)

N/A

& Keywords Criminal penalties, hazardous materials transportation, nuclear materials, packaging and containers, reporting and recordkeeping requirements

10. Abstract NRC fogulations in 10 CFR Part 71 establish requirements for packing, preparation for shi ment, and transportation of licensed material, and prescribe procedures, standards, and foquirements for apporval NRC of packaging and shipping procedures for fissile material and for quantities of licensed materialin excess of Type A quantities.

11 Artected pubhc (Wes wwy we v ets mers o mer acc& we *q 17 Obbgabon to respond (Wre pwiery we F emt es omers mer app & ne x*)

e Individuals or households d Farms a Voluntary P b Busmess or other for prord X e FederalGovernment b Required to otdam or retam tenefds X c. Nul ftw. profit insututons X f State.Locai,or TrhiGovernment P c. Mandatory 13 Cnnual reportmg and racerdkeepmg hour burden 14 Annual repurtmg and recordkeepmg cost butden rm mousems: at swers) e Number of respondents 350 a Total annualtred capriaLatartup costs 0 b Totalannualresponses 1.13 b Total annual costs (OAM) 0

1. Percentage of these responses c. Total annualued cost requested 0 conected electromcany 0 d Current OMB inventory 0

c. Total annual hours requested 63.537 e Difference O d Current OMO inventory 73.897 f. Explanation of difference o Drflerence (10.360) 1. Program change

f. Explanation of difference 2. Adjustment 1 Program change (6.906) 2 Adjustment (3.454) 15 Purpose of information collecten 16 Frequency e' recordkeeping or reporti heck a# that apply)

(Mart primary with 4"and a# others inaf an# with 'M X a Recordk pmg b Third-party disclosure a Apphcaton fut benorits o. Pmgram plannmg or management T c. Reporbng b Program evaluanon f Research X' 1 On occasen 2 Meekly 3 MunthN

c. General purpose stabstics p g Regulatory or comphance 4 Quartetty 5 sembannualty 6 Annualty d Audd

7. Bentualty 8 Other (describe)

17. Statisheat methods 18 Agency contact ( who can test answer ovestAma regaong the content of thrs su sskm)

Does thrs Informaten collecton employ stabstical methods?

Nam. Diane S. Flack NMSS

[ Yes X No Phone- (301) 415-5681 9709110257 970909 OMB 834 PDR ORG NIRC ' 1' PDR

19. Certification for Paperwork Reduction Act Submissions I

On behalf of this rederal agency, I certify that the collection ofinformation encanpassed by this request cunplies with 5 CIH 1320.9, NOT11; 'Ihe text of 5 CFR 1320.9, and the relatal provisions of 5 CIH 1320.8(b)(3), appear at the end of the instructions. The certylcation is to be made with refennce to those regulatoryprovisions as setforth in the instructions, The following is a surnmary of the topica, regarding the pmposed collection ofinformation, that the certification covers:

(a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication; (c) It reduces burden on small entities, (d) It ines plain, coherent, arul unambiguous terminology that is understandable to respondents, (c) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements, (g) It inforrns respondents of the information called for under 5 Cit 1320 8(b)(3):

(i) Why the information is being collected, (ii) Use ofinformation, (iii) Ilurden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory),

(v) Nature and extent of confidentiahty; anxi (vi) Need to display currently valid OMll control number; (h) It was developed by an office that has planned and alkicated resources for the efficient and ciTective management and use of the information to be collected (see note in item 19 of the instructions).

(i) It uses etrective and eflicient statistical survey methalology; and (j) It makes appropriate use of infonnation technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement.

Sqnatur of Senior Ofnclat or desgnee Date u

e 8

SUPPORTING STATEMENT FOR 10 CFR PART 71 PACKAGING AND TRANSPORTATION OF RADIDACTIVE MATERIAL (3150 0008)

REVISIONT0ibEEXTENSION Description of the Information Collection NRC regulations in 10 CFR Part 71 establish requirements for packaging, preparation for shipment, and transportation of licensed material, and

-prescribe procedures and standards for NRC approval of packa"ing and shipping procedures for fissile material and for quantities of other .icensed material in excess of Ty)e A quantities, This revision includes the requirements for the " Rule to Ac11 eve Compatibility with the International Atom.c Energy Agency (IAEA)," for which OMB has already implemented the burden.

A. JUSTIFICATION

1. Need for and Practical Utility of the Collection of Information Section 71.5 requires that licensees who transport licensed material outside the confines of their plant or other place of use, or deliver licensed material to a carrier for transport. including cases when Department of Transportation (DOT) regulations are not applicable, conform to the standards and requirements of 00T specified in Section 71.5(a). including marking and labeling of packages. Licensees are also required to file with the Comission any requests for modifications, waivers, or exemptions from the requirements of-DOT regulations appropriate to the mode of transport.

Section 71.7(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 a)plicants or licensees. No formal program is required. What is expected is tlat 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.

Section -71.8 specifies that licensees may submit an application for an exemption from the requirements of the regulations contained in 10 CFR Part

-71. -Upon review of the application. the NRC may grant an exemption from any particular aart of the regulation if it is determined that the exemption is authorized )y law and will not endanger life or property or the common defense and security.

Section 71.12(c)(3) requires that arior to a licensee's first use of a package under the general license estab11 sled by this section, the licensee must submit to the NRC the licensee's name and license number, and the package identification number saecified in the package approval. The information submitted pursuant to t11s requirement identifies to the NRC licensing staff the licensees who are using packages ap) roved for use by another licensee.

The licensee also commits to comply wit 1 the terms and conditions of the specific approval. Unless users are required to register prior to first use of a package, it would not be possible to notify users of changes to the package designs which could affect safety. Knowledge of the identity of users is also essential to the inspection program. This is a one-time requirement.

Persons need only report if they plan to make use of a particular package design.

Sections 71.13(a)(3) and 71.13(b)(3) require that a unique serial number be assigned to, and legibly and durably marked on the outside of each Type B package approved under NRC regulations. A unique serial number is necessary to determine whether an individual package has been fabricated before the

specified date.

Sections 71.31. 71.33. 71.35. and 7137 s)ecify the information required in a license application under Part 71 for eac1 proposed packaging design.

Srction 71.31 sets forth the general requirements including the submission of toformation specified in sectiore 71.33 through 71.37 and requires the

-applicant to identify in an application any established codes and standards proposed for and maintenance, useuse.in package in the design, absencefabrication, assembly, of any codes testing,he and standards, t applicant must justify the basis used to formulate the package quality assurance program. This requirement is necessary because these codes serve as a safety basis for the package, Section 71.33 specifies requirements for a description of the proposed package in suf f1cient detail to identify the package accurately and provide a sufficient basis for evaluation of the

-package. Section /1.35 specifies requirements for package evaluation. __

Section 71.37 sp'.scifies requirements for identification and description of the quality assurdr',ce program. The NRC Transportation Licensing staff reviews the information submitted with the application to determine whether an applicant's package design, description, evaluation, quality assurance program, and other procedures and programs described in the application are adequate to meet all specified requirements.

Section 71.38(c) requires an a3plicant applying for renewal of an existing Certificate of Compliance (paccage ap)roval) or Quality Assurance Program Approval to combine all previously su)mitted material (which is st.11 applicable) in a consolidated application. It is Agency practice f information submitted by an applicant in support of its application for approval, when that information constitutes a safety related commitment on the part of-the applicant, to reference that-information in the approval certificate. To reference a large number of documents for this )urpose can be confusing and therefore detrimental to safety. The purpose of t1e consolidation requirement is to minimize the number of documents referenced- ,

and thereby clarify the licensees' obligations.

Section 71.39 specifies that the Commission may at any time require further information in order to enable it to determine whether a license, certificate of compliance, or other approval should be granted. denied, modified.

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suspended, 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 and the common defense and security. The additional information submitted is reviewed by the NRC Transportation Licensing staff to assess the adequacy of the applicant's design, procedures, and other measures for protection of the public health and safety and the common defense and security and to meet all specified requirements. The NRC review of the information and the findings derived therefrom form the basis for NRC decisions concerning the issuance, modification, or revocation of licenses, certificates of compliance, or other approvals.

Section 71.47(c) requires a shipper to provide written instructions to a carrier for maintenance of exclusive use shipment controls. These instructions must be included with the shipping information. These

- instructions are necessary to avoid actions that will unnecessarily result in increased radiation levels or radiation exposures to transport workers or members of the general public. This requirement is currently contained in Department of Transportation (DOT) regulation 49 CFR 173.425(b)(9) and is added to these regulations to provide compatibility. These requirements have been previously a) proved under OMB Clearance No. 2137-0510. which should be referred to for tie information collection burden and supporting data.

Section 71.85(c) recuires that, before the first use of any packaging for the shi) ment of 11censec material, the licensee mark the packaging with its model num)er, serial number, gross weight, and a package identification number assigned by NRC. This information is necessary to-identify the packaging and arovide assurance to others that the packaging meets the requirements of 10 CFR Part 71.

Section 71.87(e) and (f) require that the licensee have written procedures for setting any pressure relief devices on the package and for loading and closing the package These written procedures are necessary to provide-assurance that the package and any pressure relief device provide the proper protection of-the licensed material during both normal and accident conditions of 'ransport.

Section 71.89 requires that prior to delivery of a package to a carrit r for transport, the licensee shall ensure that any special instructions needed to s safely open the package have been sent to or have been made available to the  !

consignee for his use in accordance with 10 CFR 20.1906(e). These instructions are needed so that the package is safely opened without exposure of eit er h workers or the pub lic to licensed material Section 71.91(a) requires the licensee to maintain records of each shipment of licensed material not exempt under Section 71,10 for three years after the-last shipment for which the package was used. These records must include identification of the packaging by model number and serial number, verification that' there are no significant defects in the packaging, volume and identification of the coolant, type and quantity of licensed material in each package and in the total shipment, results of the determinations required by Section 71.85 and by the conditions of the package approval, etc. These records are required to' determine whether the licensee's shipping activities are conducted in accordance with the authorization in the license.

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Section 71 91(c) requires the licensee to maintain sufficient written records to turnish evidence of the quality of the packaging. These records are to include results of the determinations required by Section 71.85 and of the monitoring, inspection, and auditing of work performance during design, fabrication, assembly, testing, modification, maintenance, and repair of the packaging, These records are recuired to determine whether the licensee's shipping activities are conductec in accordance with the authorization in the

-license. The records are to be retained for three years after the life of.the packaging to which they apply.

Section 71.93(c) requires that the licensee notify NRC at least 45 days prior to f abrication of a package to be used for the shipment of licensed material having a decay heat load in excess of 5 kW or with a maximum normal operating pressure in excess of 103 kilopascal gauge. This information is needed to give NRC ins)ectors the opportunity to verify independently that a package (cask) for tle shipment of hazardous cuantities of radioactive material (spent

-nuclear fuel) is constructed in accorcance with the approved package design and quality assurance program. Certain vital parts of casks are covered up by other components during fabrication and are not inspectable after the completion of fabrication.

Section 71 95 requires that licensees report to the NRC within 30 days any instance in which there is a significant reduction in the effectiveness of any authorized packaging during use; and details of any defect with safety signi-ficance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence. In addition. Section 71.95(c) requires licensees to report instances in which the conditions of approval in the certificate of compliance were .2 observed in making a shipment. This requirement is needed to arovide feedback to NRC concerning the adequacy of approved packages and paccage approval techniques, fhe reports are an important part of the program to improve the qualitV of packaging for licensed.

radioactive material and the related regulatory review process: to provide assurance that any defective packages will be removed from use without incident; and to determine that existing procedures for loading and operating casks are adequate to ensure compliance with the-certificate of approval.

Section 71.97 requires each licensee to give advance notification to the governor of a State, or the governor's designee of the shipment of licensed material through, or across the boundary of, the state. The notification must be in writing, must contain the name, address, and telephone number of the shipper, carrier, and receiver of the irradiated reactor fuel or nuclear waste; a description of the irradiated reactor fuel or nuclear waste, the point of- origin of the shipment, the seven-day period during which departure of the shipment is expected to occur, and the seven-day period during which arrival of the shipment at State boundaries is estimated to occur: the destination of the shipment and the seven-day period during which arrival of the shipment is estimated to occur, and a point of contact, with a telephone number, for current shipment information. Licensees must retain a copy of the advance notification as a record for three years. Licensees must-also give notice of revisions to schedules and of cancellations of shipments for which notification was given. Licensees must keep for one year a record of the name of the individual-in the Governor's office who was contacted and informed concerning a revision in shipment schedule information. In addition, licensees are required to retain a copy of the cancellation notice as a record 4

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l for three years. The records are required in order to permit NRC inspectors

! to determine compliance with the regulations.

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Sections 71.101 through 71.137 establish quality assurance (0A) requirements that apply to all activities affecting the components of packaging that are significant to safety. Sections 71.101 and 71.103 specify licensee responsibility for establishin Prior to use of any package for shipment of licensed material,g a OA program.the licensee shall file a description of its 1

, program with NRC and obtain its approval or notify the NRC of its intent to e apply its previously-approved Part 50. Appendix B program to trans)ortation activities. Section 71.103 requires licensees to clearly establisi and delineate, in writing, the authority and duties of persons and organizations

- performing activities affecting the safety-related functions of structures, systems and components. Section 71.105 requires the establishment of a OA-

. program that complies with the requirements of Sections 71.101 through 71.137.

I The licensee is required to document the 0A program by written procedures or

instructions and carry out the program in accordance with those. procedures j -throughout the period during which the packaging is used. Section 71.107 i ' requires the establishment of written procedures for package design control

' Section 71.109 requires licensees to establish measures to assure that adequate quality is required in procurement documents. It also requires that licensees shall, to the extent necessary, require contractors or subcontractors to provide a 0A program consistent with the applicable provisions of Part 71. Section 71.111 requires that activities affecting quality be prescribed by documented instructions, procedures, or drawings.

Section 71.113 requires the establishment of measures to control the issuance of documents, such as instructions, procedures, and drawings, including changes thereto. which prescribe all activities affecting quality.

Section 71.115 requi?es the establishment of measures to assure that purchased material, equipment. and services conform to the )rocurement documents. and requires that such documentary evidence be availaale prior to installation or use of.the material and equipment. The licensee must retain, or have available, this documentary evidence and assure that the evidence is-sufficient to identify the specific requirements met by the purchased material and equipment. Section 71.117 requires the establishment of measures to assure identification and control of materials, parts, and components, either by number on the item or on records traceable to the item. Section 71.119 requires the establishment of measures to assure that special processes, including welding, heat-treating. and non destructive testing, are controlled and accomplished by qualified personnel using qualified procedures, in accordance with applicable codes, standards, specifications, criteria, and other special requirements. Section 71 121 requires the establishment of a program for inspection of activities affecting quality, including specification of any necessary mandatory hold points in appropriate documents.

Section 71.123 requires written procedures for a test program to demonstrate that the packaging components will perform satisfactorily in service and requires that the test results be documented and evaluated. Section 71.125 requires the establishment of measures to assure the proper control, calibration, and adjustment of tools, gauges, instruments and other measuring

-and testing devices. Section 71.127 requires the establishment of measures to control the handling, storage. shipping, cleaning.. and preservation of materials and equipment.to be used in packaging in accordance with instructions to prevent damage or deterioration. Section 71.129 requires-establishment of measures to indicate, by the use of markings such as stamps.

tags, labels routing cards, or other suitable means, the status of 5

inspections and tests performed on individual items of the packaging.

Measures are also required for indicating the operating status of components of the packaging. such as tagging valves and switches. to prevent inadvertent operation. Section 71.' 31 requires the establishment of documented procedures for controlling materia s, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation.

Section 71.133 requires establishment of measures for documenting the identi-fication, cause, and correction of significant conditions adverse to quality.

Section 71.135 requires that the licensee maintain sufficient written records to furnish evidence of activities affecting quality, including design records, records of use and the results of reviews. inspections, tests, audits.

monitoring of work performance, and materials analyses, as well as closely

.related data such as qualifications of personnel, procedures, and equipment.

The records must include a records retention program that designates factors such as duration, location, and assigned respons1bility. The licensee shall retain these records for 3 years beyond the date when the licensee last engages in the activity for which the quality assurance program was developed.

If any portion of the written procedures or instructions is superseded, the licensee shall retain the superseded material for 3 years after it is

' superseded. Section 71.137 requires that a comprehensive system of planned and aeriodic QA audits be carried out in accordance with written procedures or checcl1sts, and that audit results be documented and reviewed by management.

The purpose of these 0A raquirements is to assure that packages are designed, fabricated, tested, procured, used, maintained, repaired, and modified in accordance with the Certificate of Compliance (approval) issued for the package.

2. Acency Use of the Information

- The NRC reviews- the information submitted with the applications to determine if the applicant's package design, description, evaluation, quality as.urance program, and other procedures are adequate to meet all the-applicable requirements in 10 CFR Part 71 and the DOT regulations and to protect the public health and safety and the common defense and security.

Additional.information provided by the licensees is also used as part of the

-basis for NRC decisions on the issuance, modification. or revocation of licenses, certificates of compliance, or other approvals.

The NRC revicws the reports and records submitted under 10 CFR Part 71 to determine whether the licensee's shipping activities are conducted in accordance with the authorization in the license and applicable requirements.

The agency reviews the licensees' quality assurance programs to ensure that packages are designed. fabricated, tested. 3rocured, used, maintained, repaired, and modified in accordance with tie Certificate of Compliance (approval) issued for the packaging.

3. Reduction of-Burden Throuah Information Technolooy There are no legal obstacles to reducing the burden associated with this information collection. Applicants and licensees may use electronic information processing systems to prepare and submit required information and i

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may use electronic sending and receiving devices to request and obtain approvals.

4. Effort to Identify Dunlication and Use Similar Information The Information Requirements Control Automated System (IRCAS) was searched to determine duplication. None was found. In the United States, only NRC.

Department of Transportation (DOT). and the States impose requirements relative to radioactive material trans)ortation. A review of NRC requirements in 10 CFR 71. 00T requirements in 49 C R 173. and State requirements in

" Suggested State Regulations for Control of Radiation." (prepared by NRC the

. National Center for Devices and Radiological Health of the U.S. Department of Health and Human Services (HHS), and the U.S. Environmental Protection Agency (EPA)). reveals no duplication. Neither a review of these documents nor interviews of persons knowledgeable in the contents of these documents reveal any evidence of duplication.

-In addition. NRC has adopted a single package approval system (Certificate of Com)liance for each package design) and subsequent registration of other users

' wit 1out additional technical data that has minimized duplication by licensees and others (DOE State licensees).

There is no similar information available. A review of NRC requirements in 10 CFR Part 71. DOT requirements in 40 r.FR Parts 173-178 and State recuirements in " Suggested State Regulations for tantrol of Radiation." preparec by NRC, HHS and EPA reveals no similar information which could be used for these purposes.

5. Effort to Reduce Small Business Burden Most businesses which transport Type B or fissile packages or deliver them-to a carrier for transport are not small businesses as that term is defined in the Regulatory Flexibility Act. Moreover, since the health and safety consequences of improper handling or transport of radioactive material are the same for large and small entities, it is for the most part not possible to reduce the burden on small businesses by less frequent or less complete reporting or recordkeeping procedures. However, the effort required to consolidate renewal ap)lications is proportional to the size and extent of a licensee's program, macing the required effort naturally less for a small business.

6. Consecuences to Federal Proaram or Policy Activities if the Collection is Not Conducted or is Conducted less Freauently i

Applications for new package certifications are submitted only once. A consolidated a) plication is required only at renewal time every five years.

The serial num)er information required by S71.13 and S71.85 is only collected one time. Other information is collected as dictated by specified events.

Written instructions for exclusive use shipments are needed each time one of these shipments is made so no less frequent collection is possible.

Recording shipmen:. data, including package serial number. at the time of each shipment is necessary to ensure compliance. .Less frequent collection would impair the ability of NRC to evaluate the adequacy of the safety of package designs for transport and would not permit NRC to carry out its obligation to 7

, , , , ,,,,e ensure that adequate measures are taken to protect the public health and safety.

7. Circumstances which Justify Variation from OMB Guidanca Contrary to the OMB Guidelines in 5 CFR 1320.5(d). Section 71.7(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 1320.5(d). Section 71.95 requires that licensees report to the NRC within 30 days any instance in which there is a significant reduction in the effectiveness of any authorized packaging during use, and details of any defect with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence. This requirement is needed to provide feedback to NRC concerning the adequacy of approved packages and package approval techniques. This is a one-time requirement. Only those persons who note a substantial reduction in the ef fectiveness of an authorized package during use, or a defect with safety significance, are required to report under this provision, amounting to only one or two reports a year. The reports are an important part of the program to improve the quality of packaging for licensed radioactive material and the related regulatory review process, and reporting within the prescribed time is needed to provide assurance that any defective packages will be removed from use without incident.

Contrary-to the OMB guidelines in 5 CFR 1320.5(d). Sections 71.91 and 71.135 require that quality assurance records be retained for three years after the packaging to which they apply. These records are needed in order to be able to demonstrate and permit a determination at any time during the life of the Jackage, and af ter any accident involving the package, that the package has Jeen designed, fabricated tested, procured, used, maintained, repaired, and modified in accordance with the approved package design and quality assurance program.

8.. Consultations Outside of NRC For information concerning DOT regulations NRC consulted with the Radioactive Materials Branch. Division of Hazardous Materials. U.S. Department of-Transportation. Washington. DC 20590.

An invitation to comment on the 10 CFR Part 71 information collection requirements was published in the Federal Reaister on June 5, 1997 (62 FR 30888). There were no comments.

9, Payment or GFt to Respondents Not applicable.

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10. Confidentiality of Information None, exce)t for proprietary information. Some proprietary information may be included w1en necessary to provide an adequate response. An application to withhold such information from public disclosure may be made, and would be disposed of, in accordance with the provisions of 10 CFR 2.790.

11. Justification for Sensitive Ouestions This information collection does not involve sensitive questions.

12. Estimated Burden and Burden Hour Cost The burden estimates for the 10 CFR Part 71 information collection requirements are based on submittals to NRC in past years. The cost to the licensees and applicants is calculated at a rate of $125 per hour for professional staff for preparation of the reports prepared in response to the 10 CFR Part 71 information collection requirements. This rate is based on

' NRC's fully recoverable fee rate and includes both salaries and overhead.

The total annual burden for complying with the information collection requirements in Part 71 is estimated to be about 63,537 hours0.00622 days <br />0.149 hours <br />8.878968e-4 weeks <br />2.043285e-4 months <br /> for-approximately 350 licensees. Most of this burden is for NRC licensees.

Agreement State licensees are required to comply with the Department of Transportation regulations in Title 49. The only NRC transportation requirements that they must comply with are in Section 71.12(c)(3),

registration prior to first use of a package design. The reporting burden for both Agreement State and NRC licensees is included in the Section 71.12(c)(3) burden.

The details of the_ burden for the reporting and recordkeeping requirements are shown in Tables 1 and 2. res)ectively. The total cost for the NRC licensees would be $7.942.125 (63.537 1ours x $125/ hour). For further details on the cost for the NRC licensees see Table 3.

13. Estimate of Other Additional Costs-None. For licensees required to submit reports under 10 CFR Part 71 it is most likely-that purchases of equipment _and services were made (1) prior to October 1. 1995. (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or' keep records for the government. or (4) as part of customary and usual-business or private practices.

14~ Estimated Annualized Cost to the Fedtral Government The annual cost for the NRC to process and review the records and reports required by 10 CFR-Part-71 is estimated to be approximately $3.182.585 (see Table 4). The majority of the cost is for professional staff review of the reports, which accounts for $2.600.000. These costs are fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.

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15. Reasons for Chance in Burden or Cost There has been a reduction-in the estimated burden and cost for preparation.

-submittal, and review of the 10 CFR Part 71 information collection requirements since submittal of the previous OMB extension package.

The reduction in burden associated with this particular extension request is because of the reduced burden for 10 CFR 71.101 through 71.137. Subpart H -

"Ouality Assurance." Since the last extension request there has been (1) a significantly reduced number of licensees (including the radiography licensees that now have to comply with 10 CFR 34.31) that have to comply with the 10 CFR 71.105 requirement for a OA program: (2) an improved estimate of the time actually required by licensees to pre)are the OA program for submittal: and (3) fewer new, complex OA g ograms suamitted and more changes and amendments to earlier programs submitted.

This revision to a clearance extension also includes the increased burden previously approved by OMB for a 10 CFR Part 71 rulemaking, " Rule to Achieve

' Compatibility with the International Atomic Energy Agency (IAEA) " This

' revised burden is reflected in the reporting burden for 10 CFR 71.38(c).

71.85(c). 71.95(c), and 71.97 and in the recordkeeping burden for 10 CFP 71.13(a)(3) and (b)(3), and 71.91(a) and (c).

16. Publication for Statistical-Use None.

17. Reason for Not Disolavina the Exoiration Date The 10 CFR Part 71 requirements are contained in a regulation, Amending the Code of Federal Regulations to display information that, in an annual publication. could become obsolete would be unduly burdensome and too difficult to keep current.

18. ExceDtions to the Certification Statement There are no exceptions.

B. COLLECTION OF INFORMATION EMPLOYlNG STATISTICAL METHODS Statistical methods are r.ot used in this collection of information.

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TABLE 1 Estimate of Comoliance Burden Renortino Reauirements Licensee No. of Licensee Staff Hours Total Annual Section Resnonses Annually Per Submittal licensee Burden (Hrs) 71.5 2 0.5 1 71.7(b) 35 1 35 71.8 Burden is included in 71.31 71.12(c)(3) 200 1 200 71.31~ 100 300 30,000 71.33 Burden is included in 71.31

-- 71. 35 - Burden is included in 71.31 71.37 Burden is included in 71.31 71.38(c) 40 50 2.000 71.39 20 1.000 20.000-71.47(c) Burden is covered in OMB Clearance No. 2137-0510 71.85(c) 100 1 100 71.89 100 0.17 17 71.93(c) 1 1 1 71.95 2 24 48 71.95(c) 20 1 20 71.97 100 0.9 90 71.101 - 71.137 .25 120 L2M Total 755 56.712 11

TABLE 2 Recordtenninq Reauirement S

• Total Record No. of Annual Hours per Recordleeping Retention Recordkeepers Recordkeener Hours Period 71.13(a)(3).

(b)(3) 350 1 350 3 yrs 71.87(0).(f) Burden is included in 71.91 Life of Pkg

+ 3 yrs 71.91(a).(c) 350 18.50 6.475 Life of Pkg

+ 3 yrs 71.97 Burden is included in 71.91 3 yrs 71.135 Burden is included in 71.91 Life of Pkg

+ 3 yrs Total Number of Recordkeepers: 350 Total Recordkeeping Hours Annually: 6.825 TOTAL ANNUAL BURDEN (HRS): ,,

63,537 12

TABL E 3 i

Estimated Cost to Public to Resnond

~

Section. Annual Cost to Resnood

, 71.5 $125 71.7(b) $4,375 j

] 71.8 Burden is included in 71,31 71.12(c)(3) $25,000 71.13(a)(3),(b)(3) $43,750 l

71,31 $3,750.000 71.33 Burden is included in 71,31 l 71,35 Burden-is included in 71.31 L ,

! 71.37- Burden is included in 71'.31 71.38(c) $250,000

71.39 $2,500,000 j 71.47(c) Burden is included in DMB Clearance No. 2137 0510-71.85(c) $12,500-71.87(e) & (f) Durden is included in 71.91 2.

- 71.89 $2,125 t

71,91 $809,375 I .71.93 $125

[ 71.95 $8,500 71.97 $11,250

?

71,101 - 71.137 $525,000 TOTAL $7.942,125 13

. TABLE 4 Estimate of Cost to the Federal Government Annual Cost - NRC Staff Review (Professional effort - 20,800 hours0.00926 days <br />0.222 hours <br />0.00132 weeks <br />3.044e-4 months <br /> @ $125/hr) = $2.600.000 Annual Cost - Clerical Processing (Clerical effort 4.160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> @ $60/hr) -$ 249.600

-Annual Administrative Costs (Postage, handling envelopes, etc.) =$ 1.825 Annual Cost for Record Holdings (1.440 cu. ft x $209/cu. ft.) =$ 300.960

- Annual Printing Costs -$ 200 Annual ADP Cost -$ 30.0AQ Total Annual Cost = $3.182.585 4

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