ML20195D641

Request for OMB Review & Supporting Statement Re Application for Matls License - Medical, 10CFR35.Estimated Respondent Burden Is 12,000 H

ML20195D641
Person / Time
Issue date:	05/29/1986
From:	Norry P NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
OMB-3150-0041, OMB-3150-41, NUDOCS 8606040351
Download: ML20195D641 (4)

Text

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Request for 0MB Review t% sem.o.e 19s33 Imp:rt nt R:ad instructions be' ore comp eting fctm. Do not use the same $F 83 Send three copies of this form. the material to be reviewed. anit for to request both an Eiecutne Order 12291 review end approval under paperwork-three copies of the supporting statement. to. -

the Pap,erwork Reduction Act. Of fice of informatron and Regulatory Affasts Answer all questions in Part 1. If this request is for review under E.O. Office of Management and Budget 12291, complete Part 11 and sign the regulatory certification. If this Attenteon: 00cke! Library. Room 32OI request is for approva! unde

• the Pape work Reduction Act and 5 CFR Washington. DC 20503 1320. skip Part it, comp;ete Part til and sign the paperwork certification.

PART l.-Complete This Part for All Requests.

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2. Agencycode

1. Department / agency and B.ireaufoffice orig'nating request U.S. fluclear Regulatory Commission 3 1 5 0

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Telephone number

3. idame of person who can best answer questions regarding this request ,

Norman McElroy (301 ) 477 41nn _

c. Title if information collection or ruiemaking NRC. Form 313M, " Application for Materials License - Medical"

5. Legal authority f or inf ormat.on t oilection or rute (cr e unoted States Coc'e. Puohe taw. or becutne 0rcer)

N Usc 2201(o) . o,

6. Attected public (check allthat apply) $ @ Federalagenciesor employees e O Non.profitinst.tutions 1 O individuaisorhousenoids 3 0 rarms a O Businesses or other for profit 7 O smallbusinessesororganuations 2 @ State or tocalgovernments PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291 --

7. Cegulation identif.er Number (RIN)

_ _ _ _ ~ _ _ _ . or. None ass.gned O Type of reverw requested

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B. Type of sut> mission (check one on each category) stage of development t Q standard Cl ssifica,tiorr i O eroposed o,d, aft 2 O Pending i O us,or 2 O renaio,inierimrinai.witnprio,proposai 3 O Emergency 2 O Nonma,o, 3 0 r.nai or interim finai. witnovi poor proposai 4 0 statutoryorrudiciardeadrine - - _ _ _ - .

9. CF R section affected CFR . . _

10. Does this regulation contain reporting or recordheeping requirements that require OMB approval under the Paperwork Reduction Act . . O ves O s.-

and 5 CFR 1320? .

. 1 O ves 2 O u>

11. lf a mator rule,is there a regulatory isnpact analysis attached? .

3 0 ves a O n.,

if"No," d.d oMB waive tr e analysis' C:tlification for Regulatory Submissions in submitting this request for oMB review, the authorned regulatory contact and ' the prograan of ficial certify that the requirements of E o.12291 policy directives have been compted with. '~

Date 5 gnature of, program of ficial 5.gnature of autnorged regulatory contact Date 8606040351 060529 PDR ORG EUSOMB 3 2. t0Af B use only) PDR staaaaear.ien sliv. e:

h ms e r.t.oas obso'ete 83 1o8 Pn e.e. s t3 9 LsN 7540o0 63a 403a $Cral):Ga-sto ; -

PART IH.-Complete This PIrt Cnlyif th2 Rzqu st is f:r Apprcvticf a Call;ctirn of Information Under the Paperwork Reduction Act and 5 CFR 1320.

13. Abstract-Describe needs, uses and affected pubbe in 50 iwords or less

" Radiation safety, Radioactive materials" Applications for specific licenses to possess and use byproduct material in humans are filed on NRC Fonn 313M. Information submitted on the form is used to evaluate the applicant's experience, training, facilities and procedures: to ensure adequate protection c,ca..

,a nrnsin win 14!TypEo~fAfo'r5 Eo'n"cofEtEn/checYo/tly'o'ne)

Informatter :ellectlans not containedin rules 2 O cmergency submission (cerreficatioaartache<>

10 Regular submission information collections containedin rules 7. Enter date of espected or actual Federal 6 Final or intenm final without prior NPRM 3 Esisting regulation (no change proposed) Reg' ster pubiscation at this stage of ruiemaking 4 O Notice of oroposed ruiemaking(Neau) A O Regutar submission

(= oath. aar rear >:

e O Emergency submissica(cert ficat>oa attachea>

5 0 rinai. NpRu =as previousi, pubiished

15. Type of review requested (check only one) ,

r 4 O Reinstatement of. previousiy approved co iection for wh;ch appeo.ar 1 O New collection has espired Revision of a currently approved collection 5 O rusting coiiection in use without an oue cont,oi number 3 @ Estension of the esperation date of a cureentty approved collection without any change in the substance or in the method of coffection

22. Purpose of information collection (check as many as apply)

16. Agency report forrn number {s)(onclude standard /optionalform osumber(s)) -

1 O Appi;cationfor benerits NRC Form 313M 2 Program evaluation

17. Annual reporting or disclosure burden 3 O Generalpurposestatistics 1 Number of respondents . .. @b 4 Q Regulatoryorcompfiance l 5 LJ Program planningor management 2 Number of responses per respondent ..... _

3 Total annuat responses (hne l t,mes hne 2) ...

600 - 6 0 Research 20 7 O Audit 4 Hours per response . ..........

S Totat hours (hne 3 tomes line M 12.000

23. Frequency of recorch eeping or reporting (check all that apply)

13. Annualrecordkeeping burden 1 Recordkeeping 1 Number of recordheepers . . . . .....

1. eportlas 2 Annualhovi >er recorcheeper. . . .....

3 Totai recordkeeping hours (hne 2 times kne 2) .. 2 O onoccasion 4 Recordkeeping retention period years 3 O weekiy .

4 O uontney

19. Tralannual burden 1 Requested (kne J 7 5 plus Ane JS3) . .. ..

12.000 s O overterir 12.000 s O semiannuairy 21n current oM8 inventory . . . . .....

0 7 O Annuairy 3 Difference (line fless Ane2) . . . ..... 8 O Siennialty Esplanallen of difference 9 G Other(describe): Initial annlicatinn a nri 4 Pros arn change . . .......... siihsonitont ; yoar ronowal S Adjustment . .

24. Respondents

• obligation to comply (check the strongest 06 legation that amfics

20. Current (most recent) eM B controf number or comment number 1 O voiuntary 3150-0041 2 O Requieed to obtain or retain a benefit

21. Requested espiration date .

3 O Mandatory 3 years form approval da te

25. Are the respondents primarily educational agencies or institutions or is the primary purpose of the c

26. Does the agenc use sampling to safect respondents or does the .agency . . . recommend

. . . . . .or .prescritae

. . . .... the use. O ves 0%

of sampling byteipendenid . . . . . . . . .............

27. Regulatory authority for the information collection ;or.other(spec,ry):

10 35.4  : o, Fa crR Paperwork Certification in submitting this request for OMS approval, the agency head the senior officist or an authorued representa Privacy Act. statistical standards or directives, and any other apphcable information policy directives haveDate been complied w.th.

S snature of program officist .

oate 5 gn:ture of agency head.tne sen.or cit.c.aior an aangaed representative Patricia G. Norry, Director U%

s Offico- nr m.m -

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O SUPPORTING STATEMENT FOR NRC FORM 313M

' APPLICATION FOR MATERIALS LICENSE - MEDICAL" 10 CFR PART 35 Justification NRC regulations in 10 CFR Part 35 require the submission of applications for specific licenses to possess and use byproduct material in humans. The form currently in use for this purpose is NRC Form 313M, " Application for Materials License - Medical ." NRC has published a proposed rule which would revise 10 CFR Part 35 in its entirety and would implement the use of

_a new form, NRC Form 313, fon-medical applications. Until such time as that rule becomes effective and guidance for use of the new form is in place, NRC will continue to use Form 313M.

Agency Use of the Information The NRC staff will review the information submitted on NRC Form 313M 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.

Reduction of Burden Through Information Technology There is no legal impediment to the use of information technology for the reduction of burden associated with this requirement. The information may be prepared and submitted using automated office equipment.

Efforts to Avoid Duplication The Federal Information Locator System was searched to determine NRC and other Federal agency duplication. None was found. NRC is the only Federal agency that requires the submission of information on radiation safety programs for the medical use of reactor-produced isotopes (byproduct material ) . NRC has closely coordinated its medical licensing program with FDA and other government agencies.

Effort to Use Similar Information 10 CFR Section 30.32(a), which applies to applications for Part 35 licenses, specifically provides an opportunity for the applicant to avoid repetition in filing licensing submittals by incorporating by reference any information previously submitted.

Efforts to Minimize Burden on Small Businesses The NRC carefully designed this form to only request the information needed to provide an adequate assurance of public health and safety that is sufficient to meet NRC's responsibility as set forth in the Atomic Energy Act. Small businesses that use isotopes for medical use in a limited scope of activities are not required to submit as much information as a large business engaged in a wide scope of activities.

O Consecuences of Less Frequent Collection This application is submitted for the initial license and for renewals every five years. The application process requires that licensees perform a comprehensive review of their entire radiation safety program assuring that all activities will be or are being conducted safely and in accordance with NRC regulations. The submission and review of the information required on the application form is essential to NRC determination of whether the applicant's training, experience, equipment, facilities, and procedures for the use of byproduct material are adequate to protect the public health and safety. Less frequent collection would compromise the ability of NRC to make

. licensing decisions and monitor the continuing safety of licensed operations.

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

Consultations Outside the Agency There have been no consultations outside the agency since the previous clearance of this information collection requirement.

Confidentiality of Information NRC Form 313M contains a Privacy Act statement describing routine uses of the information. Information provided on this form is available through Freedom of Information Act procedures. Proprietary and personal information is considered to be confidential. Information is stored in a controlled access file room.

Sensitive Questions None.

Estimated Compliance Burden No. of Submissions Licensee Staff Total Annual Licensee Annually Hours / Submittal Burden (Hours) 600 20 12,000 Estimated Cost to Public to Respond Total Annual Licensee Burden (Hours) Rate / Pour Total Industry Cost 12,000 $32.00 $384,000

Source of Burden and Cost Data and Method of Estimating Burden and Cost This data is based on staff experience and on the number of submittals received by NRC in past years. Cost to licensees and applicants is calculated at a rate of $32 per hour, which is an average figure that takes into account both professional and clerical time. The figure of 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> per submittal is also an average. New applications may require 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, while renewals would probably average 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />. With an annual submission of 100 new applications and 500 renewals, this would translate to a burden of 4,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> for new applications and 8,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> for renewals, or a

_ total of 12,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br />. __

Estimated Cost to the Federal Government The estimated cost to the Federal government for processing and reviewing the information submitted is $478,200, which includes approximately 6,770 hours0.00891 days <br />0.214 hours <br />0.00127 weeks <br />2.92985e-4 months <br /> of professional staff review time at $60/hr and 2.400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> of clerical staff time at $30/hr.

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