ML20140B107

Request for OMB Review & Supporting Statement Re Application for Medical Matls License.Estimated Respondent Burden Is 1,000-h

ML20140B107
Person / Time
Issue date:	08/20/1981
From:	NRC OFFICE OF ADMINISTRATION (ADM)
To:
Shared Package
ML20140B104	List: ML20140B100 ML20140B107
References
NUDOCS 8109110486
Download: ML20140B107 (11)

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.REEUEST FOR OMB REVIEW l (Und:r th3 Pap rwork R: duction Act and Executivo Order 12291) l Imprrt:nt - R2sd instructions (SF-83 A) bsfora complating this Offica of Information and Regutatory Affairs form. Submit the required number of copies of SF-83 together Office of Management and Sudget with the material for which review is requested to: Wa shington. D.C. 20503

1. Dspartment/ Agency and Bureau / Office originating request 3.Name(s) and telephorie number (s) oi person (s) who can best U.S. Nuclear Regulatory Commission $*0' Ton *n'el"U*{ldN E7 *d511 S -

2. 6-digit Agency / Bureau number (firstpart of 11-digit Treasury 4. 3-dugit f unctional code (last cart of 11-digt! Treasury Account Account No.) No.)

3 1 0 2 0 0 2 7 6 5 Tstis of information Collection or Rufemaktng C. Is this a tutemaning submission uncer Section 350Mh) of PL.96-511 ? (Check one)

Application for Materials Licens ' 1xx No tsection 3so7 submission)

Medical - NRC form 313M 2 O Yes,NPAM. Expected date of publication:

, 6. A Is any information coIIection (reporting orrecordkeeping) 3 0 Yes.finat rule. Espectec Cate of puchcation.

involved? (Check one) Lifective cate:

14 Yes and proposat is attached ti review D/At what phase of rulemaking is this submission made?

2 0 Yes but procosalis not attached - skip to Question D.

3 O No - skip to Question *). 1XX Not applicable B Ara the respondents primar Iy educationalagencies or 2 0 Major ruf'. at NPRM stage instotutions or is th a purpose related to Federal education 3 O Maior Final rulu for wnich no aPRM was published programs ? 4 O Major Final rule. af ter pubhcation of NP AM O Yes U No 5 O Nonmajor rule.at NPRM stage 6 O Nonmaler rule, at Final stage COMPLETE SHADED PORTION IF INFORMATION COLLECTION PROPOSALIS ATTACHED *

7. Current (or former) OMB Number 8. Requested 12. Agency report form number (s) 3150-0041 Excitation Date NRC Form 313M Expiration Oste 13. Are respondents only Federa! agencies ?

9/ 3 0/ 81 9/30/84 a ye3 x_x No

3. ls proposed information collection tested in 14. Type of request (Check one) the information collection budget? 1 O pre nminary ptan

% Yes O No t

10. Will this proposed infot mation collection 2 O new (nut prev,ously aweved or esp.rea enore than 6 moms cause the agency to exceed its information ago) collection budget allowance? (llyes. attach O Yes XX No 3 D revision amenament reques t from agency head.)

a a enters,c , lamustment to Ltcen orny)

11. Number of report forms submitted for approval -1 5 R extension (no change:

(NRC Form 313M) 6 0 reenstatement texmree we un s morr 1,

15. 16. Classification of Change in Burden (explain in supporting statement) e Acoron' mate site of l un....s- o s.w s N/A No of Reseonses No of neoort no sot.rs Cost t: tme r ub"c 3 sire et s.r c a. in inventory N/A 500  : 1,000 5 e [.,,.. e nomeeror resoOnde9ts or b As proposed 500 l '1,000 ls reem..o.rs o., v."

500 c Ditference (b-a) l ]s e 41eorts ennu.ii ,i ey eac,, Explanation of difference (indicate as many as apply) rispondent ferem 25)

Adjustments e totsten % .ir.sorries +

r.,,e o c . esc d. Correction-error 1 l l+ 3 500 -

i t simi.o .....e

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, f. Change in use i .1 l2 S 2

Program changes 3 Isi msted tciaiaou,s eienassieuroen.n r,,c., veu rom i<, . rs "

g increase *

{+ hS l.000 h. Decrease - ~

0109110486 810820 o.-

PDR Of.O EUSOMB standarc Forni 83 (Rev. 3-S t)

PDR Fer QKO6FFG9EOSI14%

SUPPORTING STATEMENT FOR FORM HRC-313M 10 CFR PART SS, SECTION 35.4 A.I. Justification (i) NRC regulations in 10 CFR Part 35, Section 35.4, require that applications for specific licenses to possess and use byproduct material in humans are to be filed on " Application for Materials License - Medical," Form NRC-313M. ,

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(ii) The NRC staff will review the information submitted on Form. NRC-313M to determine whether an app}icant 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.

(iii) There is no source for the required information other than applicants.

(iv) ~NRC is the only Federal agency that requires the submission of information en 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 to assure that information requested is not duplicative.

(v) This application is only submitted for the initial license and for renewals every five years thereafter. The application process .

requires that licensees perform a com'prehensive review of their .

entire radiation safety program to assure that all activities will be or are being conducted safely and in accordance with NRC regulations.

The review and submission of the information required on the appli-cation form is essential to NRC's determination of whether the applicant has training, experience, equipment, facilities, and procedures for the use of byproduct material that are adequate to protect thd public health and safety. Two hours is a reasonable period for the preparation and submission of this application form.

(vi) N/A

2. Description of Information Collection (i) It is estimated that approximately 500 applications will be submitted to NRC annually on Form NRC-313M. .

(ii) Applicants will fill in the information requested on Form NRC-313M and submit the original and one copy to NRC.

(iii) None.

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(iv) N/A (v) None.

(vi) The nattre of the activities involved (e'.g., medical use of byproduct materials by hospitals, doctors' offices, etc.) does not require the submission of proprietary information. The form contains a Privacy Act statement on page 4. The submitted tpplications are stored in a secure docket file room. They are only released to the public on request after screening out personal and proprietary information, if any. No files are maintained by name of individual.

(vii) None.

(viii) None.

3. Time Schedule for Information Collection and Publication Applicants- for new licenses or renewals of existir.g licenses will submit Form NRC-313M with the requested information. New applications may be submitted at any time. Renewal applications are required to be submitted every five years. Requests for additional information to complete or clarify the information submitted in the application or "to rectify deficiencies in proposed programs would be issued as necessary. The NRC expects that an average of one additional information request per submittal will be needed, and that this request would normally be issued within three months of the initial submittal. Responses to requests for additional information would normally occur within two months, and the NRC would normally take appropriate licensing action within abcut one month of the availability of all required information.

4. Consultations Outside the Agency There have been no consultations outside the a~gency since the initial GA0 clearance of the form.

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5. Estimate of Cotgliance Burden It is estimated that approximately 500 applications will be submitted annually to NRC by applicants on Form NRC-313M. -

Each application will require approximately two staff hours to prepare.

500 x 2 staff hours = a total annual burden for ,all applicants of 1,000 staff hours.

6. Sensitive Questions None.

7. Estimate of Cost to Federal Government The cost to the Federal Government is estimated to be approximately 5320,000 annually.

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Fonu NRC-313M U.S. NUCLE AR REGULATORY COMMISSION Approved;

'" APPLICATION FOR MATERIALS LICENSE - MEDICAL G AO R0557 10 CF R 35 INST R UCTIONS - Compere ttoms t arough 26 of this a an omtrarappi, cat >on or an wes car.on for rene~at of a t. cense use supplementas sheets where necessary item 26 must be completed on all appiscarsons and sogned Betaan one copy. Submit orogonal and one copy of entore apptocar.on to : Dorector. Offoce of Nuclear Maternals Safety and Safeguards. U 5. Nucreer Regulatory Comm ss.on Wasnongton. OC.

20$$$. Upon approval of thus wolicarnon the anpikant owls recerne a Matenals i scense. An NRC Materials L <ense is assued on accord-anse awth the generalreque,ements contaonedin Totte 10l Code of foderal Regulatoons. Part 30. and the Lncensw as subrect to Title 10 Code of Froers! Beguistoons, Parts 19. 20 and 35 and thelocense fer prowsoon af Totor 10. Code of federal Renistrons. Part 170 The letense fee category should be stated on item 26 and the appropriare fee enclosed 1.C. NAME AND M AILING ADDRESS OF APPLICANT (insatution, 1.tt STREE T ADDRESS (ES) AT WHICH PAi>lO ACTIVE MATERIAL firm,ekmc.physicsan, etc) INCLUDE ZIP CODE WILL BE USED (if dif4 rent from f.aJ it.f;iUDE ZIP CODE TE LEPHONE NO.: ARE A CODEI ) __ '

2. PERSON TO CONTACT REGARDING THl$ APPLICAT ON *L THISIS AN APPLICATION FOR: (Check appropriate intr *J a6 O NEW LICENSE tx 0 AMENDMENT TO LICENSE NO.

c. O RENEWAL OF LICENM NO.

TE LEPHONE NC.. ARE A CODE I )

4. INDIVIDUAL USERS IName ind,eiduals who willuse or directly 5.R ADIATION S AFETY OFFICER (RSO) (Name ofperson otseptated supervose use of radioactive material. Complete Supplements A and B as radostran safety offocer. If other than indrafust user complete resu-for each indevodual.) me of traomng andempenence as in Suppbement AJ

6. st RADIOACTIVE MATERIAL FOR MEDICAL USE  !

M A) tim UM MARK MAXIMUM

- ITEMS POSTESSION ITEMS POSSESSION -

RADIOACTIVE MATERI AL DEEIRED Lausys ADDITIONAL ITEMS: DESIRED LIMITS LISTED IN: "X (In millicurses) "X" (in mr!Iscurres)

IODINE.101 AS lODIDE FOR TREATMENT 10 CFR 31.11 FOR IN VITRO STUDIES OF HYPERTHYROIDISM 10 CFR 35.100. SCHEDULE A. GROUP l AS NEEDED PHOSPHORUS-32 AS SGLUBLE PHOSPH ATE.

FOR TRE ATMENT OF POLYCYTHEMIA

_V ER A.LEUKEMI A AND BONE METASTASES 10 CFR 35.100. SCHEDULE A. GROUP ll ASNEEDED PHOSPHORUS 32 AS COLLOtDAL CHROMIC PHOSPH ATE FOR INTR ACAVITARY TRE AT-MENT OF MALIGN ANT f ff"USIONS.

10 CFR 35.100. SCHE DULE A. GROUP lli GOLD-198 AS COLLGID FOR INTRA.

CAVITARY TREATMENT OF MALIGNANT 10 CFR 35.100, SCHEDULE A. GROUP IV AS NEE DED E F FUSIONS.

IODINE 131 AS IODIDE FOR TREATMENT 10 CFR 35.100. SCHEDULE A, GROUP V AS NEEDED OF THYROID CARCINOMA XENON.133 AS GAS OR GAS IN S ALINE FOR -

10 CFR 31.100. SCHFDULE A. GROUP VI BLOOD FLOWSTUDIES AND PULMONARY FUNCTION S1'10!ES.

6.b. R ADIOACTIVE MATERI AL FOR USES NOT LISTED IN ITEM 6.a. ISwedsources up toJmCiused!cr cabbraroon and reference standards are authorised under Section 33.14(dl.10 CFR Part 35, and NEED NOT BE LISTEDJ CHEMICAL M AXIMUM NUMBE R El SM.*;NT AND MASS NUMBE R AND/OR OF MILLICURIES DESCRIBE PURPOSE OF USE PHYSICAL FORM OF EACH FORM l

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F O M M N RC-313M

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INFORMATION REQUIRED FOR ITEMS 7 THROUGH 23 Fcr items 7 through 23, check the appropriate box (es) and submit a detailed description of all the requested information. Begin each item on a separate sheet. identify the item number and the date of the application in the lower right corner of each page, if you indicate that an appendix to the medical licensing guide will be followed, do not submit the pages, but specify the revision number and date of the referenced guide: Regulatory Guide 10.8 , Rev. Date:

7. MEDICAL ISOTOPES COMMITTEE U' GENERAL RULES FOR THE SAFE USE OF RADIOACTIVE MATERIAL (Check One)

Names and Specialtle Attar:hed;and Appendix G Rules Followed;or Duties as in Appendix B;or Equivalent Rules Attached $

(Check One)

Equivalent Duties Attached 10. EMERGENCY PROCEDURES (Check One) l

8. TRAINING AND EXPERIENCE Appendix H Procedures Followed;or l Supplements A & B Attached for Each Individual User:

and E@h Prem AMW -

Supplement A Attached for RSO. 17. AREA SURVEY PROCEDURES (Check One)

9. INSTRUMENTATION (Check One) Appendix 1 Procedurea Followed;or:

Appendix C Form Attached;or Equivalent Procedures Attached List by Name and Model Number. 18. WASTE DISPOSAL (Check One) .

10. CAllBR ATION OF INSTRUMENTS Appendix J Form Attached;or Appendix D Pro;;edures Followed for Survey EquivalentInformation Attached Instruments: or (Check One)

Equivalent Procedures Attached;and 19.

A ADIONARMACEMC (Check One)

Appendix 0 Procedures Followe-J for Dose Calibrator;or Appendix K Procedures Followed;or (Check One)

Equivalent Procedures Attached Equivalent Procedures Attached

11. FACILITIES AND EQUIPMENT 20. THERAPEUTIC USE OF SEALED SOURCES Description and Diagram Attached Detailed Irformation Attached;and ' ~ ~

12. PERSONNEL TRAINING PROGRAM Appendix L Procedures Followed;or (Check One) j Description of Training Attached Equivalent Procedures Attached PROCEDURES FOR ORDERING AND RECEIVING PROCEDURES AND PRECAUTIONS FOR USE OF

' RADIOACTIVE MATERI AL 21. RADIOACTIVE GASES (e.g., Xenon - 133)

Detailed Information Attached Detailed Information Attached PROCEDURES FOR SAFELY OPENING PACKAGES

14. CONTAINiNG RADIOACTIVE MATERIALS '

22. RADIOACTIVE MATERIAL IN ANIMALS (Check One) Detailed Information Attached Appendix F Procedures Followed;or PROCEDURES AND PRECAUTIONS FOR USE OF

23. RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6.b Equivalent Procedures Attached . Detailed information Attached FORM N3C-313M

. (8 78) } hoe 2 v ': =

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24. PEPSONNEL MONITORING DEVICES SUPPLIE R EXCHANGE FREQUENCY (Check approperate bout FILM .

o. WHOt.E TLO BODY OTHE n tSpecufy) i FILM a

b. FtNGER TLO n.

> OTHE R (Specofy) ,

FILM

c. WRIST TLO OTHER (Steci&l

d. OTHER (Seweifyl

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25. FOR PRIV ATE PR ACTICE APPLICANTS ONLY a HOSPIT AL AGREEING TO ACCEPT PATIENis CONT AINING H ADIOACTIVE M ATE HI AL N AME OF HOSPIT AL tt ATTACH A COPY OF THE AGREEMENT LETTER SIGNED BY THE HOSPITAL ADMINISTRATOR.

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c. WHEN REQUESTING THER APY PROCEDURES, ATTACH A COPY OF R ADI ATION SAFETY PRECAU.

CIT Y '

STATE ZIP CODE TIONS TO BE TAKEN AND LIST AVAILABLE .

' R ADIATION DETECTION INS.TRUMENTS. -

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26. CERTIFICATE (7his item must be completed by applicant) - ' .. v The app'icant and any official esecuting this certificate on behalf of the appbcant named in item la certify that this apbilc$ tion 6s epared in' confort:dtv m.th Title 10, Code of Federal Regulations, Pa<ts 30 and 35, and that aH information containea herein, including uny supplements

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tttached hereto,is true and correct to the best of our knowledge and belief. '

t1. APP. LICANT OR CERTIF YIN.G OF. FI.CI AL (S,iriaturel a LICENSE FEE REQUIRED '

(See Seetoon 170 31,10 CFR 1701 (1) N Aus (Type of Print) *'

' ,Q) TITLE

81) LICENSE FEE CATEGORY. ,

1 (2s LICENSE FEE ENCLOSED $

F OMM NRC.313M (8-78)

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l PRIVACV ACT STATEMENT

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..-4 Pursuant to 8 U.S.C. 552 ate)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93 579), tne following ,

statemeat is furnished to individuals who supply information to the Nuclear Regulatory Commission ~onTarm NRC 313M. '

This information is maintained in a system of records designated as NRC 3 ar3 described at 40 Federal Regi, ster 45334 (October 1,1976). , ', _',f '_ _,_,1 , _, _ ,

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1. AUTHORITY Sections 81 and 161(b) of ins Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 2201(b)). '

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2. PRINCIPAL SURPOSE(8) The information is evaluated'by the NRC staff pursuant to the crite'rla ' set forfh'in"10 CFR i Parts 3046 to determine whether the application meets the requirsments of the Atomic Energy Act of 1954,as amended,-- i and the Commission's regulations, for the issuance of a radioact!ve materiallicense or amendment thereof. . ,

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3. ROUTINE USES The information m'ay be used: (a) to provide records to State health departme,nts for their !nformation and use; and (b) to provide information to Federal, State, and local health officials and otner, persons in the~ event of inci-dont or exposure, for their information, investigation, and protection of the public health and safety'.].7,he informatjon may also be disclosed to appropriate Federal, State, and local agencies in the event that the information indicetc a violation or potential violation of law and in the course of an administrative or judicial proceeding. .In addition, this In -.

formation may be transferred to an appropriate Federal, State, or local agency to the extent relevant.and necessary for a NRC decision or to an appropriate Federal agency to the extent. relevant and necessary f_or that agency's decision abo.ut you. A copy of the license issued will routinely be placed in the NRC's Fublic Document. Room,1_717 rt Street, N.W.n _

Washington, D.C. ,

4. WHETHER DISCLO8URE 18 MANDATORY OR VOLUNTARY AND EFFECTON INDIVIDUAL OF NOT PROVf CING INFORMATION Disc:esure of the requested 'nformation is voluntary, if the requested information is not furnished, however, the application for radioactive material license, or amendment thereof, will not be processed.  !

5. SYSTEM MANAGER (8) #.ND ADDRESS Director, Division of Fuel Cycle and Material Safety, Office of Nuclear Mats-rlal Safety and Safeguards, U.S. Nuctaar Regulatory Commission, Washington, D.C. 20555.

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FORM NRC.313M t e ema .m , .

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FOmM FmC-313M-SUPPLEMENT A U.S. NUCLEAR REGULATORY COMMISSION rm TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIATION SAFETY OFFICER l

2. STATE OR TERRITORY IN

-1. NAME OF AUTHORIZED USER OR RADIATION SAFETY OFFICER WHICH LICENSED TO PH ACTICE MEDICINE

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3. CERTIFICATION __

CATEGORY MONTH AND YEAR CERTIFIED SPECIALTY BOARD C A

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4. TR AINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES TYPE AND LENGTH OF TRMNING LECTURE / SUPERVISED FIELD OF TRAINING LOCATION AND DATh tSi OF TRAINING LABORATORY LABORATORY A B COURSES . EXPERIENCE (Hours) (Hours)

C D

a. R ADI ATION PHYSICS ANO INSTRUMENTATION

b. R ADIATION PROTECTION

c. MATHEM ATICS PERTAINING TO THE USE AND ME ASUREMENT OF RADIOACTIVITY

d. RADI ATION BIOLOGY

e. R ADIOPH ARM ACE UTICAL CHEMISTRY l

5. EXPERIENCE WlTH R ADI ATION. (Actust use of 11adioisotopes or Equivalent Experience)

MAXIMUM AMOUNT WHERE EXPERIENCE WAS G AINED DUR ATION OF EXPERIENCE TYPE OF USE ISOTDPE FORM NRC-313M Supplement A W 78) Page 5 l

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Pc M NRC 313M SUPPLEMENT 8 U. S. NUCLE AR REGULATOR). COMMISSION l (6-78)

PRECEPTOR STATEMENT Supplement B nut be completed by the soplicantphysician'spreceptor. If more than one preceptcr is necessary to document C:perience, obtain a separate statemen t from each.

1. AFPLICANT PHYSICI AN'S NAME AND ADORESS KEY TO COLUMN C PUf,L N AMg PERSON AL PARTICIPATION SHOULD CONSIST OF:

14upervised enemination of potlants to determine the suitebility f or radioisotopo diagnosis and/or trestrrect and recommendetion f or prescribed d9seps.

3 ADDRESS 740fleboration in dose calibration and actual administration of dose N the patient including calculation of the radiation dose,related rnessurements and b 'ulng of data.

3. Adequate period of tre.ning to enable physician to manage (1dioective ClTV l ST ATE l ZIP CODE petients and follow patients througri diagnosis and/or course of treatment.

2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN NUMSER OP CASES INVOLVING COMMENTS CONDITIONS DI AGNOSED OR TRE ATED PE RSONAL (Aoditioselin fonnation or comments may ISOTOPE ,

PARTICIPATION be submitsedin duplicate on sacereas sheets 1 A 8 C D DI AGNOSIS OF THYROID FUNCTION DETE RMIN ATION OF BLOOD AND BLOOD PLASM A VOLUME ,

1 131 LtViR FUNCTION STUDIES or 1125 FAT ABSORPTION STUDIES Kl9NEY FUNCTION STUDIES IN VITRO STUDIES OTHER 1125 DETECTION OF THNOMBCSIS 4 131 THY ROID IM AGIN G P 32 EYE TUMOR LOCAll2ATION So 75 P ANCRE AS IM AGtNG Yb 169 CISTE RN OGR APHY y,333 BLOOD FLOW STUDIES AND PULMON ARY FUNCTION STUDIES OTHER BRAIN iM AGING CARDI AC IM AGING .

TH Y R OlD IM AG3NG ,

SALIVARY GLAND IMAGING Tc 99* 5LOOD POOL IMAGING PLACENTA LOC ALIZ ATION UVER AND SPLEEN IMAGING l UNG IM AGING BONE IM AW .G '

OTHER FORM NRC.113M. SUPPLEMENT B (s.7s> Page 8 j

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PRECEPTOR STATEMENT (Continued)

2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN (Continued l

NUMBEE OF CASES INVOLVING COMMENTS PE R$3NAL (A#rsonalmfonnation er commens may be ISOTOPE (X3NDITIONS DI AGNOSED OR TRE ATE D submetod on okoplocan on separser sheen)

PARTICIPATION A B C D _

P.32 TRE ATMENT OF POLYCYTHEMIA VER A, ISoAMI LEUKEMIA, AND BONE METASTASES INTR ACAVITARY TRE ATMENT ICose eri TRE ATMENT OF THYROID CARCINOMA

• 1131 TREATMENT OF HYPERTHYROIDISM A.a198 INTRACAVITARY TRE ATMENT Co60 INTE RSTITI AL TRE ATMENT or Co137 INTR ACAVITARY TREATMENT f.125 or INTERSilTI AL TRE ATMENT 1r-19 2 G ef.,0 or TELETHE RAPY TRE ATMENT ,

Cp137 Sr-90 TRE ATMENT OF EYE DISE ASE R ADIOPHARMACE UTICAL PREPAR ATION

((9fd GE NE R ATOR GENERATOR Tc-93m RE AGENT '(ITS

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1 DATES AND TOTAL NUMBEf2 OF HOURS RECEIVED IN CLINICAL RADIOISOTOPE TRAINING

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6. PRECEPTCTS SIGN ATUHE 1 THE TRAINING AND EXPERIENCE INDICATED ABOVE WAS OBTAINED UNDER THE SUPEFiVISION OF:

a NAME OF SUPE RVISOR S

h N AME OF INSTITUTION 7. PRECEPTOR'S NAME Please type orariarl

c. 48 AILING ADORESS ,o e cli v 8.DATE DTXlE Ri ALS LICE %E NUMBE dis)

F OR%4 NRC.J13%$uPPLE YE N T 8 to-7ei Page 7 3

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