ML20005F528

Request for OMB Review & Supporting Statement Re NRC Form 483, Registration Certificate - in Vitro Testing W/ Byproduct Matl Under General License

ML20005F528
Person / Time
Issue date:	01/02/1990
From:	Amenta J NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0038, OMB-3150-38, NUDOCS 9001160361
Download: ML20005F528 (7)

Text

_.

Request for 0MB Revlea _Q, siandyd ro,m s:

" %g 1 y

i

[

A (Rev September 1983) s.: c - -

"D[(Qj V

important Read instructions before completing 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 Executive Order 12291 review and approval under paperwork-three copies of the supporting statement, to:

the Paperwork Reduction Act.

Answ;r all questions in Part 1. If this request is for review under E.O.

Office of Information and Regulatory Affairs 12291, c:mplete Part 11 and sign 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 it, complete Part 111 and sign the paperwork certification.

Washington, DC 20503 PART l -Complete This Part for All Requests.

1. Departmont/ agency and Bureau / office onginating request,

2. Agency code 3 15 0 U. S. Nuclear Regulatory Comission

3. Name of person who can best answer questions regarding this request Telephone number Sterling Bell l(301 3 492-0617

4. Tit:3 of mformation collection or rulemaking NRC Form 483 Registration Certificate - In Vitro Testing With Byproduct Material Under General License

s. Legal authonty tor information collection or rule (cite linited States coce, Public las'. or becutovv 0rder) 47 UsC 770llol

- or

6. Affected pubhc(check allfhatapp'y) 5 0 rederaiagenei.sor.mpior s 1 O indmduaisorhousenoids 3 0 rarms s E Non-profitinstitutions 2 O stateoriocaigovernments 4 0 Businessesorotnerfor profit 7 E smatibusinessesororganizations r

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

7. RegWati:n identifier Number (RIN)

_ _ _ _, or. None assigned C

8. Type of submissson (check one on each category)

Type of rev6ew requented Cieself6 cation Stage of development 1 O standard 1 O Maior 1 O Proposedordraft 2 O pending 2 O Nonmajor.

2 O rinaiorintenmfinai.witnpnorproposai 3 0 Emergency 3 0 rinaiorintenmfinai,witnoutenorproposai 4 O statutoryorjudiciaideadhne.

9. CrR section affected.

CrR-

10. Does this regulation contain reporting or recordkeeping requirements that require oMB approval under the Paperwork Reduction Act.

1 and 5 CrR 13207.,

.. O ves O No 11 lf a major rule.is there a regulatoryimpact analysis attached?.,,,........,..

,... 1 0 v.s 2 0 No 1

if"No," did oMB waive the analysis?

3 O v.s 4 0 No Certification for Regulatory Submissions -

J w-in submitting this request Ior oMB review, the authorized regulatory contact and the program official certify that the requirements of E.O.12291 and any applicable policy Croctives have been comphed with.

',_)

sgnature of progym offgiai Date 5,gnatura of authonzod regulatory contact 4

.t rs 4

12.(OntB use only)

Previous editens obsolate 83-108 '

stenaard f orm a3 (Rev. 9 83)

NSN 75400 634-4034 Presenbed ty oMB 9001160361 5 UR 1320 anno.12291 M 102 PDR ogn EUSOMB g

PDC

_-. _ _. _. - - ~ _ - _

-- -6. A. 4.. 3 5

PART lli.-Complete This Part C71y if the Request is for Approval of a Collection a,-

of Information Under the Paperwork Reduction Act and 5 CFR 1320.

Ig. Abstract-Describe needs, uses and affected pubric M So words or less

~"

Radioactive Materials, Radiation Safety" Persons wishing to use radioactive byproduct material for in vitro clinical or laboratory testing under general license must register with NRC by suliiiiitting NRC Form 483. The certificate, when validated by NRC, serves as ev$dence'.to supplier.s ofibyproduct-material that

_Lhe reaistrant is entitled in varaiva the ma+arial.

~

14. Type of intormation collection (check only one) 11 formation collections not contained in vueen 1 @ Regular submission 2 O tmersencysubmission(certif,cationattached; Information csNections contained he rules n

n4wg 3 O Existing requietion (no charige propaeed) s rinal or interim final without pnor NPRM

7. Enter date of expected or actual Fedevel 4 O Notice of proposed rulemaking(NPRM)

A O Regularsubmission -

Register publication et this etage el rutemakirig -

5 O Final. NPRM was previously published ; ;

e O tmersency submission (certificar>on attached)

(menta. dar >**r>:

15. Type of review requested (check only one)

'TT, l 1 O New collection

' - 4 O Reinstatem.nt of a previousiy approved cosisetionserwh'ich approval 1

1 2O Revissonof acurrentlyapprovedcollection has expired 3 0 Extension of the expiration date of a currentir approved coliection s O Existing coli ction in use without en oMe control number without any change in the substance or in the method of collection

16. Agtney report form number (s)(snclude standard / optional form number (s))

22. Purpose of intormation collection (check as manyas appfy)

NRC Form 483 1 O Apphcation for benefits 2 O Program vaiustion -

17. Annual reporting or disclosure burden 3 0 Generalpurposestatistics 250 4 g p,goi,,,,yo,,,mpi;,,nc, 1 Number of respondents ;

2 Number of responses per respondent 1

5 O Program planning or management 3 Total annua! responses (hne 1 times kne 2) 250 6 O Research 4 Hours per response...

O.120 7 O Audit

- ~ ~ -

• 5 Total hours (kne 3 timesline 4) 30

10. Annualrecordkeepmgburoen

23. Frequency of recordkeepmg or reporting (check aff inet appfy) --

4 u.

w 1 Numberof recordkeepers.

10 Recordkeeping 2 Annual hours per recordkeeper.

1. eportirqr 3 Total recordkeeping hours (line 1 times line 2) 2 C onoccasion 4 Recordkeeping retention penod years s O weekiy

19. Total annual burden 4 O Montniy 1 Requested (kne 17 5 plus hne 18-3).

30 s 0 quartersy 2 in current oMB inventory 30 s O semi-annua;ir 3 Difference (hne f less hne 2) 0 7 O Annuaiiy Explanation of dMerence 8 O Biennially 4 Program change 9 3 other(describe):

Ona tima 5 Adiustment.

20. Current (most recent) oMB controi number or comment number

.24. Respondents'obligationtocomply(checkthestfortgest06dgetionthetapphes) 3150-0038 1 O voluntary w t)v

21. Requested expiration date 2 3 Required to obtain or retain a benefit 3 years from approval date 3 O uandatory

25. Are the respondents primarily educational agencies or institutions or is the primary purpose of the collection related to Federal education programs?.O Yes @ No

26. Does the agenh use sampling to select respondents or does the agency recommend or prescribe the use of sampling or sta by respondent

27. Regulatortauthonty for the informqtion collection 1U 31.11(b)

CFR

or rR

or,other(specify)

Paperwork Certification in submitting this request for oMB approval, the agency head, the senior official o,r an authorized representative, certifies that the requirements of 5 CFR 1320. the Privacy Act, statistical standards or directives, and any other applicable information policy directives have been comphed with.

S; nature of program official Date

. Sign:ture of agency head, the senior official or an authorized representative Date Joyce A. Amenta, Designated Senior Offi ial W

l for Information Resources Managemen

- f /y m. _

p y.,. g h

41 GPO 1984 0 - 453-776

'i

)

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

1[ Radioactive Materials, Radiation Safety" Abstract-Describe needs, uses and affected pubhc tri S0 words or less Persons wishing to use radioactive byproduct material for in vitro clinical or laboratory testing under general license must register with NRC by suP5itting NRC Form 483.

The certificate, when validated by NRC, serves as evidence.to suppliers of byproduct-material that the reaistrant is entitiett tn raraiva +ha

=>+=r4=1

14. Type of information collection (check only one)

Intermation conectione not containedin rules 1 E Reguiar submission 2 O tmersency suomession(certificat<onertsched>

Llormatten ceNectJene contained in rules i

3 O taisting reguistion (no charge proposed) s rinal or intenm final without pnor NPRM

7. Enter date of expected or actual Federal l

4 O Notice of proposed rulemaking(NPRM)

A O Regularsubmission Register publicaten at this stage of rulemakirig 5 0 rinai. NpRu was previousiy pubiisned e O tmersency submission (certir, cation attached >

(month. dar. )**r>:

15. Type of revew requested (check only one) 1 O New collection 4 O Reinstatement of a previounty approved coiiection for which approvoi a O Revision of a currently approved collection has expired 3 O Extension of the expiration date of a currently approved coliection 5 O Existmg cotiection m use witnout an oMe controi number without ey char *Ie m the substance or m the method of conection lg. Agency report form number (s)(onclude standard / options: form number (s))

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

NRC Form 483 1 O Apphcation for benefits 2 O Program evaluation

17. Annual reporting ur disclosure Durden 3 O ceneraipurposestatistics 1 Number of respondents.

250 4 g p,,i,,,,,,,,,,pi3.nc, 2 Number of responses per respondent.

1 5 O Program plannmg or management 3 Tetal annuai responses (hne J fimes hne 2) 250 e a p.,,,,en 4 Hours per response.

O.120 7 g Audit Q Total hours (hne 3 times line a) 30

13. Annuet recordheepmg burden

23. Frequency of recorckeepmg or reporting (Check a# thatappfy) 1 Number of recordkeepers.

1 O Recordkeeping 3 Annual hours per recordkeeper.

1. ePorting 3 Total recordkeeping hours (hne J times hne 2) 2 O onoccasion 4 Recordkeepmg rctention penod years 3 0 weekiy

19. Totalannual burden 4 O Montniy 1 Cequested(hne 17 5 plus line 18 3).

30 5 0 Quarteriy 2 In current oMB mventory 30 s O semi annuaiiy 3 Difference (hne 1 less hne 2) 0 7 O Annuaiiy EspJanetten ef dlNerence 8 0 B<enntal\\y 4 Program change 9 3 other(desenbe):

Ona tima 5 Adiustment.

20, Current (most recent) oMB control number or comment number

24. Respondents' obhgation to comply (check the strorquet oedgetsort thatapplies) 3150-0038 1 O voluntary

21. Requested expiration date 2 3 Required to obtain or retam a benefit 3 years from approval date 3 O Mandatory

25. Are the respondents primarily educational agencies or institutions or is the pnmary purpose of the collection related to Federal education programe? O Yes O No

26. Does the agen$ use samphng to select respondents or does the agency recommend or prescribe the use of hamphng or by respondents

27. Regulato authonty for tne mformation collection 1

31.11(b)

CFR rR or,other(specify):

C. ;;. Certification in submitting this request for oMB approval, the agency head, the sensor official or an authortred representative, certifies that the requirements of 5 CFR 132o. the Pnvecy Act. statistical standards or directives, and any other apphcable information policy directives have been comphed with.

Signature of program official oote Signatureof a Date Joyce A. gency nead, the senior official or an authorized representative Amenta, Designated Senior Offf ial t/

for Information Resources Managemen f /

g,,,,,,,,,

m_

f,3 7,

U

~

a m

t u

l

~

4 i

i L

Supporting Staten,ent i

for

-i NRC Form 483 Registration Certificate In Vitro Testing with Byproduct Material Under General License (10CFR31.11)

Justification Need for the. Collection.of Information Section31.11(a)of10CFRPart31providesforagenerallicensefortheuse i

of Iodine-125, Iodine-131, Carbon-14,. Hydrogen-3, Iron-59,. Selenium-75, and

~

mock Iodine-125 by any physician, clinical laboratory, hospital, or veteri-narian in the practice of veterinary medicine for the purpose of certain jn vitro clinical or laboratory testing.

The general license sets forth-the conoitions pertaining to possession and use of the byproduct material.

1

- Section 31.11(b) specifies that in order for the physician,~ clinical j

-laboratory, hospital, or veterinarian in the practice of veterinary medicine to-use the general license, NRC Form 483, " Registration Certificate - In Vitro Testing with Byproduct Material.Under General License," must be completed and-submitted to NRC. The licensee must then receive a validated copy of the.

q registration certificate with an assigned registration number to complete the.

i licensing process.

I Suppliers of byproduct material to other persons are required to determine that the person receiving the material is authorized to receive it. The validated certificate, maintained by the licensee,- serves as evidence for the supplier that a physician, clinical laboratory, hospital, or veterinarian in the a

l 2

practice of veterinary medicine is a general licensee authorized to receive the byproduct material.

Section31.11(e)requiresthatalicenseeunderthissectionreportinwriting any change in a previously validated registration certificate. The licensee-must report the change to the NRC within 30 cays after the effective cate of such change.

Agency Use.of-the Information The information derived as a result of the submission of the registration form provices NRC with the name of each physician, clinical laboratory, or hospital using byproduct material under the general license. The registration certificate contains the terms and conditions of the general license and provides a means of assurance to the NRC that the general licensee is aware of those terms and conditions prior to receipt of byproduct material.

A registration certificate is usually validated within seven days of its receipt. A validated copy is returned to the general licensee, who may then use it to obtain byproduct material from a supplier.

Reduction of Turden.Through Information. Technology There are no legal obstacles to recucing the burden associated with this-information collection. Registrants may use electronic information processing-systems to prepare and submit the required information.

Effort to Identify Duplication The Information Requirements Control Autcmated System (IRCAS) was searched to i

determine duplication. None was found.

i 3

Effort to Use Similar Information There is no similar information available to the NRC, l

Effort to Reduce Small Business Burden The majority of the registrants who use byproduct material are small businesses. The health and safety consequences of improper use or handling of radioactive byproouct material are the same for large and small entities. The burden of providing the small amount of information required on the registration form is only nominal.

The Registration Certificate is only submitted once. Therefore, it is not possible to reduce the burden on small businesses by less frequent or less complete submittal.

Consecuences of Less Frequent Collection-NRC Form 483 is only submitted once, for initial registration.

t Circumstances Which-Justify Variation from OMB. Guidelines

?

There are no variations from OMB guidelines.

Consultations Outside the Agency There have been no outside consultations since the previous clearance.

Confidentiality of Information J

L l

None.

_ Sensitive Questions None.

j l

e 4-4 i

4 l

Estimate of Compliance Burden Approximately 250 registration certificates are received annually from persons who wish to be general licensees. The time required'for completion of Form 483 is approximately seven minutes. All that is necessary is filling in the name.

and address, checking one of the categories of licensees, signing and dating the registration certificate. The total burden for all general licensees is approximately 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> annually. Since preparation of the form is essentially a

a clerical function, the cost is estimated to be approximately $25 per hour.

The total cost for preparation of the 250 certificates-would be approximately

$750.

9 Estimated Annual Cost to the Federal Government The average time needed for processing of a registration' certificate is approximately 15 minutes. At a rate of $95 per hour, the annual cost to the

~

Federal governnent based on 62.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> of effort is $5,937.50.

e 9

e n

, - +

w

-w.

w

u.a.NucLaAR RSSULATORY C000JSte0N y g,3 we ren4 m

.p auriansa (7 tU

- r. s. 4.F*J,,,.

,. cpg g u M',p i

RE0l8TRATION' CERTIFICATE WNNTESTING E.-- ~manammar""m"ase'"Jr" "8,..."".*"esa".

~

--i..-

e m, m,.

WITH BYPRODUCT MATERIAL UNDER GENERAL UCENSE 5"=,,",, m,gg,#7;*gg,,omes i

estern.).astnistr.tlen Of the byproduct estari.i O.r the r.di. tion therefrem to hwaan beings Or i or r, ie.u not in iein, me imrsen., ion u,.n., io en u....u.n s..e-c.i ucen,e...m,ormn

, u.tm.,r.nnu.i ia.r. ri, h.iui...n..eurwri.n. in toe,,unce.,

e m,. uine t

... c.,u in -n.mu ne. <., r. ci urii<

. ~ cnnu i or nietit. Postellion Of byproduct estari.i under 10 CFR

.n.n is not outnortres until the.parsici.n, cunic i 1.boratory, nnetui, or wierinert n in the er.ctice of wterinary -sicin nd received from the Commission v.iidsted copy of hRC Fore 483 with registr. tion nweer.

.?. A PP u C14 7~/0/V Zfireby ogly fora rnistesNn twMr pursuant to l

l Io CFR so. sechin 31.11, & use at bypeducMrrials Pe r:

(oese an w so+)

k Myse If, a., duly tice sseet physic /or, au teoro's.oq to dhpense. deugs ih he procr*e af a.co icine.

t l

_f The a bove=herrenf L//riotel /dbore+vry.

_f.

Yht a bove-noid r>ssi s to/.

o D.

Ve t e rsherian. irs +,6s proces of veroviru ry s&iMc, 1

I.

IN S TR UCTIONS.

Ms l'orin in Mplaats +v'.

A. M r$ +$s B

Ndscal, ddemic, ad wrerchiUse, G.t t y ruch co tl3)

Wsan fIndustrbt2 Crke orNashe/AnenW Cur)ryNediC I Hudor$1p'ry REG lsn?AT/cM N/4f8E2,'

hI&wich f* **c%'*s (1 musM

/

u.s./ u ctew 9.?uto ro o

ththir.fron, M cos~

g W Nti?.,.t. rejiha*On nuNtr 'All)lbe aGst'aned a nK.t. taiWared e) spy a /ML

\\%,,,g*/

Fernt u2 wiilbe re r:n-wf

&In sk. Ici aute, re ce?ym Hermorj c.m (IkCNJ/!57 $// :

O fWe' FWN$YJMy/$!l* f.

W gj gy y,, y,g,y y

g;g _,

2.llh Tll'bl2Cr1[0ry, /f'CWJ). OV f*ffrW'It*/lM if) assigned by NRC. If thU U e change ofinformation from a prevrously 57 UIKTC6 'M WToeistr*y #/ kra's tor Whom

!*Cssterrd generalincense, include your regotration number.)

Cf TCr Y/f' N Tb/U r '4 Sir 1%;- krm E f&,

s.-

,14.

!! place of use is different from address disted a.he,43 give complete address:

5O&T&AMN I hereby certify that:

A.

Allinformation in this registration certificate is true and complete.

B.

The registrant has appropriate radiation measuring instruments to carry out the tests for which byproduct material will be used under the generallicense of 10 31.11. The tests will be performed only by personnel competent in the use of the instruments and in the handling of the byproduct materials.

g C.

I understand that Commission regulations require that any change in the information furnished by a registrant on this registration certificate.

be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the of factive date of such change.

)

D.

I have read and understand the provisions of Section 31.11 of NRC regulations 10 CFR 31 (reprinted on the reverse side of this form); and I understand that the registrant is required to comply with those provisions as to all byproduct material which he receives. acquires, possesses, uses, or transfers under the generallicense for which this Registration Certificate is filed with thQGelear Regulatory Commission.

)

PPWrQ u T ~u PED n/ AMC A rt o -n ia. C of ar % ICA tV r s t GW Aru n C O F,4 P t.?LICANT M75 WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS.

18 U.S.C. SECTION 1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.

a