ML20209B294

Request for OMB Review & Supporting Statements Re 10CFR30 Concerning Rules of General Applicability to Domestic Licensing of Byproduct Matl.Estimated Respondent Burden Is 34,478 H

ML20209B294
Person / Time
Issue date:	12/08/1986
From:	Norry P NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
OMB-3150-0017, OMB-3150-17, NUDOCS 8702040008
Download: ML20209B294 (12)

Text

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(% w.rm- F.e3, Request for OMB Riv'iiE " ' L N-imp 2rtant Read mstructions before completmg form. Do not use the same SF 83 Send three copies of this form, the material to be reviewed, and for to request both an Ewcutive Order 12291 review and approval under paperwork-three copies of the supporting statement, to:

the Paperwork Reduction Act Answer all questions in Part 1. If this request is for review under E.O. Office of Information and Regulatory Affairs 12291, complete Part 11 and sto the regulatory certification. If this Office of Management and Budget request is for approval under the Paperwork Reduction Act and 5 CFR Attention: Docket Ubrary, Room 3201 1320, skip Part 11, complete Part til and sign the paperwork certification. Washington, DC 20503 PART l.-Complete This Part for All Requests.

1. Department /ageny and Bureau,o rtice originating request

2. A 6,ency code U.S. Nuclear Regulatory Commission 3 1 5 0

3. Name of person who can best answer questsons regardeng this regt.est Telephone number

_ Steven _L._Baggett

4. Title of information comection or rulemaking (301 1427-9005 10 CFR Part 30 - Rules of General Applicability to Domestic Licensing of Byproduct Material

5. t.egal authority for infct matton tcliection or rule (cere Unored States Code. Pubisc laev, or Enecutive Order) 42 usc _2201(o) . or

6. Affected pubhc (check att that apply)

$ @ federalagencies oremployees 1 O Ind viduals or households 3 Farrr,s 6 Non-profit institutions 2 O state orlocatgovemments 4 Q Businesses orother for o ofit 7 smari businesses or organaations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291

7. Regulatron Identifier Number (RIN)

-__- ~ _. _ _ _. _ , or, None assigned O

8. Type of submission (creck one in each carescry)

Type of review requested CI:ssification Stage of developrnent 10 Standard 1 U Major 1 O e,oposed or draft 2 O Pend.ng 2 O Nonmajor 2 O rinatorinterim fina'.with orier proposai 3 0 cmergency 3 O Final or ir. term final, without pnor proposal 4 0 statutory oriudiciaideadone

9. CFR section aftected CFR

10. Does this regulatton c.ontain report.ng or recordkeeping requ,rements that requise OMB arproval under the Paperwork Reduction Act and 5 CFR 13207

' Yes O No

11. If a magor ruie, is there a tr gt.latory impact analysis attached?

I Yes 2 E No if"No," did OMB war <e the ar,atns) 3 Yes 4 O No Ccrtification for Regulatory Submissions in submitting this request for OMB revicw. the authonzed regulatory cor: tact and the program of ficialter+ efy thet the requ!rements of L 0 12291 and any appbcable pohcy directives have been compi ed with Signature of prneram nH c W Date s gnature of authnryrd rqafatory emtact Date 8702040008 861208  ;

PDR ORG EUSOMB i

12. f onfe use ontr> PDR Pieveous ed f.ons otwee NsN 754000 634 4034 g3 g studard Form 83 (Ib 9 83)

Prescnbed by OMb 5 CrR 1320 aw E O 12791

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PART lli.-Compitta This Pzrt Only if tha Rzqunt is for Appraval of a Celltcti:n of Inforrnation Under the Paperwork Reduction Act and 5 CFR 1320.

13. Absteact-Descret.e needs, uses and affected put fic in 50 words or less

" Radioactive Materials, Radiation Safety" i The proposed regulations would provide for manufacturers of radiation sources and devices containing radioactive sources to register with NRC described safety information about their products. When referenced in applications, the registered information will be used by NRC in thedssuance_of_ specific licensm tn__the manufarhirerstruenmers_

14. Type of information conect:on (check on'y one)

Information co!Iections not containedin rules 1 O Reeviar subm ssion 2 O Ernergency submission (certshcationattached)

Information collections containedin rules 3 O Esisting regulation (no change proposed) 6 Final or interim final without pnor NPRM 7. Enter date of espected or actual Federal 4 $ Notice of proposed rulemaking(NPRM) A E Regular submission 5 0 ren,i. NPRM was previously pubhshed Register publication atgigs (month, day, year):

f rgtging B C Emergency submission (certsf, cation attached)

15. Type of review requested (checli only one) a 10 New collection 4 O Reins'atement of a previously approved collection for which approval 2 b Revision of a currently approved collection has expired 3 O Extension of the empiration date of a currentir approved coiiection 5 0 Existng collection in use without an oMB control number without any change in the substance or in the method of collection

, 16. Agency teport form number (s)(include standard / optional form number (s)) 22. Purpose of intormation collection (check as manyas apply)

N/A 1 Application for benefits 2 O erogramevaiuation

17. Annual reporting or disclosure burden 3 0 ceneraipurposestatistics 1 Number of respondents .

8,000 4 { Regulatoryorcomphance 2 Number of responses per respondent 5 U Program planrang or management 3 Total annual responses (hne 1 times hoe 2) l' '

6 O Research 4 Hours per response *N 7 O Audit 5 Tetal hours (hne 3 times hne 4J 34,470

18. Annualrecordkeepingburden 23. Frequency of recordkeeping or reporting (checA all that apply) 1 Number of recordkeepers 1 O Recordbeeping 2 Annual hours per recordkeeper. Reporting 3 Tctal recordkeeping hours (Ane 1 temes hne 2) 2 O onoccasion 4 Recordbeeping retention penod years 3 0 weekiy

19. Total annual burden 4 O Moniniy 1 Requested (hne 17-S plus hne 183) . Ob*b 0 5 Quarterly 2 in current oM8 inventory 34,478 6 0 semi-annuairy 3 Dif ference (hne l less hne 2) 0 7 O Annuaii,

Laplination of difference 8 0 Biennially 4 Progra n change 9 other(describe) 5 Adjustment .

20. Current (most recent) oM8 controi number or comment number 24. Respondents' obligation to comply (check the strongest obhgatron thatapphes) 3150-0017 i O voiunta,y j 21. Requested espiration date 2 O Required to obtain or reta.n a benefit

, 3/31/88 3 O Mandatory

25. Are the respondents pntnarily educational agencies or inst.tutions or is the pnmary purpose of the collaction related to Federal education programs? O Yes @ No

26. Does the agency use samphng to select respondents or does the agency recommend or prescnbe the use of samphng or statistical analysis by respondents? . Yes @ No 2 7. Regulatory authority for the it; formation collection 10 CFR 30.32(o)  ; or FR  : or, other (specity) f j );perwsr> Certification j in submittirg this request for oM8 approval, the ager cy head, the senior official or an authorized representative, cert fies that the requirements of 5 CFR 1320, the Pnvacy Act, statistical standards cr directives. and any other apphcable ir' formation pohcy directives have been comphed with.

signature of propam off>cial Date 3

5.gnature of agenc y head, the samor of 6cial or an authonzed rep'esentative Date Patricia G. Norby, Director O Office of Administration [A> 8 !W I 7 #O O GPO 1484 0 - 453-776 1

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,~,s...,--, Request for OMB Review important 2 Read enstrations t>efore completmg form. Do not uw the same SF 83 tthe.tequestbotttanLecut Paperwork Reduction Act ve-Ordee 12291-revieveand approvat under - paberSend three copies of this for_m theJnatenal.to befevie workrIhreelo6ies of the supporting statement, to.

Answer all questions en Part 1. If this request is for review under E.O.

12291, complete Part ti and sign the regulatory certification. If this Office of information and Regulatory Affairs request is for approval under the Paperwork Reduction Act and 5 CrR Office of Management and Budget 1320, skip Part 11, complete Part til and sign the paperwor k certification. Attention: Docket Library, Room 3201 Washington, DC 20503 PART 4.-Complete This Part for All Requests.

+ 1. Department / agency and Bureau /of f ece or genating request

2. Agencycode U.S. Nuclear Regulatory Comission 3 1 5 0

3. Name of person who can teest answer questions regarding this request Steven L. Baggett Telephone number

4. Title of information collection or rulemaking (301 3427-9005 10 CFR Part 32 - Specific Domestic Licenses to Manufacture or Transfer Certain ltems Containing Byproduct Material q

5. Legat authonty for informatson collection or ruse (cote United States Code. Public law or becutive Order) ,

42 usc ??01(n) .or-

6. Affected public (checa J// that apply) 1 O ind viduais or househoids $ federalagencies or employees 3 0 rarms 2 O stateorioca governments e O non-profitinstitutions 4 0 Businesses orother for-profit 7 10 smaii businesses or organizations

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PART ll.-Complete This Part Only if the Request is for OMB Review under Executive Order 12291

7. Regulation Identifier Number (RIN)

_ _ _ ~ _ _ _ _, or, Nonc assigned S. Type of submossoon (chech one on each category)

Classification Type of review requested Stage ef development i O Maior 1 O e,oposedordraft 1 O standard 2 O Nonmaior 2 eending 2 O Fenatorintenmfinal.withpnorproposat 3 0 tmergency 3 0 rinai or intenm finai. witnout onor praaami

9. CF R section atiected 4 0 statutory or,udiciaideadien.

CrR 10.andDoes this regulation contain reporting or recordkeeping requirementswark 5 CFR 1320' that require oMB approval under the Paper Reduction Act

. O ves O no

11. It a maior rule, is there a regulatory impact analysis attached >

it"No." did OMB waive the analysis?

i O ves 2 O no Certific tion for Regulatory Submissions 3 0 ves 4 0 no in submitting this request for oMB review, the authorized regulatory contact andand pohCy directives have been complied with the per> gram official ce any apphcable signiture of program of ticiat Date Signiture of authon/mi reguldfory contact .

Date

12. TOMB ese only)

Prenous eo.tions oosows MSN 7540 00 634 a03a' 83 108 standard form 8J (Rev 9 83)

Prescribed by OMB i

_ _ _ _ _ _ _ - _ _ _ _ - - - - - -$ CrR 132@(EM @ 83808 ---. J

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PART lil.-Cctnplit2 This Part Only if the Request is for Approval of a Collection of Inforrnation Under the Paperwork Reduction Act and 5 CFR 1320.

13. Abst,act-Descnbe needs. uses and affected pubiec in 50 words or less "Radic, active Materials, Radiation Safety" Th2 proposed regulations would provide for manufacturers of radiation sources and devices containing radioactive sources to register with NRC described safety infonnation about their products. When referenced in applications, the registered information will be used by NRC in the issuance nf enecific._ licenses to_lhe rnanufacturens' mistomers

14. Type of mformation coHection (checA only one)

Infirmation collections not contained in rules 1 O Resviar submissioa 2 O tmersency submission (cert,hcar,onattached>

Information collections containedin rules 3 0 taist.ng reguiation tno changeproposed) 6 rinai o, intenm finai witnoui pno, NeRu 7. cnte, date of ,,pectea o, actuai rederai 4 @ Notice of proposed rulemaking(NPRM) A O Regularsubmission Registerpublicationat hissta ofr king 5 0 rinai. NeRu was previousir pubiished e O Emergency submission (cert <t<at,on attached > (month, dar rear >: an. ,

15. Type of review requested (check only one) 1 O New coiiection 4 0 Reinstatement of a previously approved collection for which approval

. 2 @ Revision of a currently approved collection has expked 3 0 Extenseon of the empiration date of a currently approved collection without any change in the substance or in the method of collection 50 t>> sting coirection in use without an ous controi number

16. Agency report torm number (s)(onclude standard /optoonal form number (s)) 22. Purpose of information collection (chech as many as apply)

N/A 1 O Appi. cation for benefits 2 O Program evaluation

17. f.nnual reporting or disclosure burden 3 0 ceneraipurpose statistics 1 Numberof respondents . .

I 40 4 0 Regulatoryorcompitance 2 Number of responses per respondent. 2.5 - 5 0 Pragram ptanning or management 3 Total annual responses (Isne 1 times one 2) 100 6 O Research 4 Hours per response 22 7 O Audit 5 Totat hours (fine 3 times line 41 2.200

18. Annualrecordheepingburden 23. Frequency of recordkeepeng or reporting (checA allthatapply) 1 Number of recordkeepers 1 O Recordkeeping 2 Annual hours per recordkeeper. Reporting 3 Toto recordkeeping hours (hne 1 times hne 2) 2 D onoccasion 4 Recordkeeping retenteon penod years 3 0 weekiy

19. Tot:1 annual burden 4 0 uonthly 1 Requested (hne 17 5 plus hne 18 3) . 9 280 5 0 Quarterfy 2 in current oMB anventory 9,280 6 0 semrannuaie r 3 Difference (kne liess line 2) 0 7 O Annually Esplanation of dlHerence 8 0 Biennsalty 4 Program change 9 0 otner(descr,be):

5 Adjustment .

20. Cctrent (most recent) oMD control number or comment number 24. Respondents' obligation to comply (checA the strongest ob4gation that apphes) 3150-0001 110 voiuntary

21. Requested expiration date 2 O Required to obtain or retain a benefit j 3/31/87 _

3 0 uandatory

25. Arm the respondents primanly educational agencies or institutions or is the pomary purpose of the collection related to Federal education programs? O ves G No

26. byDoes the agencf use sampling to select respondents or does the agency recommend or prescnbe the use of sampling or statistical respondents . .

analysis

. O yes Q No

27. Regulatory authority for the information Collection 10 V 21n CFR -

or iR  ; or. other(specify),

l Paperwork Certtfication I in submitting this request for oMB approval, the agency head, the seneor official or an authorized representative, certifies that the requirements of 5 CFR 1320. the Prrstcy Act. statistical st endards or di.ectives, and any other apphcable inforrnation pohcy directives have been comphed with.

signature of program official Date hgns,tura of agency head. the se'uor offical or an authonted representative Date Patricia G. Norry, Director p Office of Administration NAw .M Irs _, O#@

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SUPPORTING STATEMENT FOR 10 CFR PARTS 30 and 32 RULEMAKING:

1 Manufacturers' Registration of Radiation Safety Information for

, Certain Devices and Sealed Sources Description of the Infomation Collection Proposed amendments to NRC regulations in 10 CFR Parts 30 and 32 would pro-vide clearly for manufacturers of radiation sources and devices containing sources to register with NRC described safety information about their products.

l When referenced in applications for licenses, the registered infomation will i

j be used by NRC in the issuance of specific licenses to the manufacturers' cus-4 tomers.

Justification Need for and Agency Use of the Information Collection ,

NRC regulations in 10 CFR Part 30 prescribe rules applicable to all persons in l the United States governing domestic licensing of byproduct material. Those l

rules, among other things, provide for the issuance of specific licenses for l byproduct material to named persons pursuant to 6 30.33 upon applications l filed pursuant to 6 30.32.

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, Section 30.33, " General requirements for issuance of specific licenses," provides, in part, that an application for a specific license will be approved if "...

the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property."

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Section 30.32 provides that information contained in previous applications, statements or reports filed with the Conunission may be incorporated into an application for specific license.

The NRC has developed an administrative practice whereby, under the general provisions of SS 30.32 and 30.33, manufacturers of radiation sources and devices co'ntaining radiation sources register with NRC certain safety infor-mation that is used in the issuance of specific licenses to the manufacturers' customers. The proposed amendments would fomalize this administrative practice for infomation collection and use by adding a new paragraph (g) to i 30.32 and adding a new 5 32.210.

paragraph 30.32(g) requires that an application for a specific license to 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 a 32.210 or with an Agreement State, or contain the radiation safety related information that is identified in i 32.210. This information is needed by the NRC to determine the adequacy of radiation safety properties of the source and device under the conditions of proposed use. This detemination is used to establish that the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property.

Section 32.210 specifies that a manufacturer or initial distributor of a sealed source or a device containing a sealed source may submit a request to NRC for evaluation of radiation safety infomation about its product and for registration of the product. The request must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, additionally, in the case of a device, sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that .

the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. This infomation is needed and used by the NRC to determine the adequacy of the radiation safety properties of the source or device under the expected conditions of use.

Under the present administrative practice, the safety information that is sub-mitted to the NRC for evaluation and registration is shared with licensing authorities in the 28 Agreement States (where NRC has relinquished its regulatory jurisdiction). Accordingly, when a manufacturer of sources and devices registers infomation about a product with a single agency, that infomation is available to 29 licensing authorities. This sharing of infomation will continue under the proposed new ss 30.32(g) and 32.210.

Use of Improved Infomation Management Technology There are no legal obstacles to reducing the burden associated with this infor-mation collection. Manufacturers requesting radiation safety evaluation and registration of their products and applicants for specific licenses may use electronic infomation processing systems to prepare and submit required infor-ma tion.

Efforts to Avoid Duplication The Federal Infomation Locator System was searched to detemine NRC and other Federal agency duplication. None was found.

The administrative practice.to be fomalized by this rulemaking avoids dupli-

• cation in that a single submission of product radiation safety infomation by a manufacthrer, when properly incorporated into applications by reference, is used by the NRC and the 28 Agreement States in the issuance of specific licenses to multiple users of the product. ,

l Effort to Use Similar Infomation There is no similar infomation available.

Effort to Reduce Small Business Burden Approximately 50% of the manufacturers and distributors and users of sealed sources and devices are small businesses. The procedures under current admin-istrative practice and the proposed rule whereby manufacturers and distributors may request evaluation and registration of their products would serve to reduce the burden for small businesses purchasing the radiation source or device, since without such registration the purchasers would each have to submit all the required safety information to NRC. Health and safety considerations preclude prefer-ential evaluation of sources and devices on the basis of the manufacturer's size.

Consequences of Less Frequent Collection Requests for source and device evaluation and registration are submitted only n

o once. Less frequent collection would impair the ability of NRC to evaluate the adequacy of sources and devices used under specific license.

Circumstances Which Justify Variation from OMB Guidelines There are no variations from OMB Guidelines.

Consultatfons Outside the Agency The practice of manufacturers' registering infonnation on sealed sources and devices was developed jointly with licensing authorities in the 28 Agree-l ment States (NRC regulates in the non-Agreement States). Also, many manu-l facturers have used the registration system under the existing administrative practice.

Manufacturers and other interested persons developed the industry standards 1

that are used by the NRC staff when evaluating the adequacy of the radiation safety properties of sources and devices used under specific licenses.

i Assurance of Confidentiality None, except for proprietary infonnation.

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Sensitive Questions None.

Publication for Statistical Use None.

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Estimate of Compliance Burden NRC's current rate of registering sealed sources and devices under its adnin ,,

istrative practice is about 100 per year (40 sources and 60 devices per year) to an estimated 40 manufacturers and distributors. This rate is expected to continue under the proposed rule.*

The NRC processes about 1500 applications per year (600 sources and 900 devices per year) for specific licenses, or amendments thereto, which reference safety information that has been filed by manufacturers and distributors of sealed sources and devices. This rate is expected to continue under the proposed rule.

The estimated average technical time required by the manufacturer or distributor to prepare a request for evaluation and registration of a sealed source is 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />.

Thus the total industry burden for sealed source registration is 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> annually .

(40sourcesx10 hrs / source). At $60/hr this represents an industry cost of $24,000.

The estimated average technical time required to prepare a request for evaluation and registration of a device is 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />. Thus the total industry burden for device registration is 1800 hours0.0208 days <br />0.5 hours <br />0.00298 weeks <br />6.849e-4 months <br /> (60 devices x 30 hrs / device), and the cost is $108,000.

The total industry burden for registration of sealed sources and devices would be 2,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> per year, and the total cost to industry would be $132,000.

W The Agreement States annually register safety information on approximately 50 sealed sources and devices which are produced by their respective manufacturers.

All the States and the NRC share registered infomation so that a manufacturer needs to register with only one regulatory group in order to market throughout the United States.

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Comparison with Alternative Collection Method The NRC annually processes about 1500 applications (600 sources and 900 devices) for specific licenses, or amendments thereto, which reference safety information that has been registered. If, in lieu of referring to registered infomation, each license applicant submitted complete safety information, each license appli-cant would have an increased technical effort in preparing the application and the manufacturers and distributors would spend more time on assisting customers in the preparation of applications for specific licenses.

If the registered information is not used, the increased technical time needed by the user to prepare an application for specific license is estimated to be 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> ($300) for a source and 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> ($900) for a device. These estimated times assume that the license applicant obtains the needed test and engineering data and some assistance from the manufacturer or distributor and, with additions or modifications as appropriate, forwards that data as part of the license appli-cation. The total additional burden to license applicants for 600 sources and 900deviceswouldbe16,500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> ($990,000) annually.

If registered infomation is not used, the increased assistance provided to each of multiple customers by the manufacturer or distributor is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> for a source and 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for a device. For 600 sources and 900 devicesthiswouldbe6600 hours ($396,000) annually.

Thus, if the registration system in the proposed rule were not used, there would be a total additional burden to the industry of 23,100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> and an additional cost of $1,386,000.

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Estimate of the Cost to the Federal Government.

The NRC professional staff spends an average of 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> on the safety evaluation of a sealed source and an average of 27.6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> on the safety evaluation of a device. Annually, for 40 sealed sources and 60 devices, the NRC professional staff spends 1896 hours0.0219 days <br />0.527 hours <br />0.00313 weeks <br />7.21428e-4 months <br /> on the safety evaluations. At $60/hr this represents

$113,760. .'The proposed rule would not change the time needed for the review of requests for evaluation and registration of sealed sources and devices.

r The NRC saves professional staff time through use of the registered infomation.

If 1500 applicants (600 for sources, 900 for devices) for specific licenses sub-mitted detailed safety information in lieu of referring to registered infomation, the NRC professional staff time spent on source and device reviews would be multi-plied by a factor of 15: 28,440 hours0.00509 days <br />0.122 hours <br />7.275132e-4 weeks <br />1.6742e-4 months <br /> ($1,706,400) annually would be required for NRC's reviews instead of the present 18% hours ($113,760).

The administrative practice and the proposed rule whereby manufacturers and distributors of sealed sources and devices register safety information about their products with NRC causes $1,592,640/yr less burden on the Federal Govern-ment than would the alternative of eliminating the registration system.

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