ML20033C748

Request for OMB Review & Supporting Statement Re NRC Form 483, Registration Certificate in Vitro Testing W/Byproduct Matl Under General License, 10CFR31.11.Estimated Respondent Burden Is 50-h

ML20033C748
Person / Time
Issue date:	11/18/1981
From:	Donoghue D, Scott R NRC OFFICE OF ADMINISTRATION (ADM)
To:
Shared Package
ML20033C745	List: ML20033C744 ML20033C748
References
NUDOCS 8112040082
Download: ML20033C748 (6)

Text

.

REEUEST FCR CMB REVIEW

-V (IJnd:r the Paperw:rk Reduction Act cnd Ex:cutiv2 Ord:r 12291) -

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L lenportant - Rxd instructions (SF 83A) bel:ta c:mpl ting this Offic] of Inform: tion cnd R;gul: tory Af f

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form. Submit the requirednumber of copies of SF 83.together Office of Management and Budget with th2 material for which review is requested to:

Washington. D.C. 20503

7. Department / Agency and Bureau /Of f ace originating request

3. Name(s) and telephone number (s) of person (s) who can best answer questions r agarding request U.S. Nuclear Regulatory Commission V: Miller (30l) 427-4002 2.6-dsgst Agency / Bureau number (firstpart of 11 digst Treasury

4. 3-digst functional code (last part of 11 digit Treasury Account Acc:unt No.)

No.)

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5. Tstn c.f Informatson Collectuon or Automaking C. ts trios a rulemakmg submission under section 3504(h) or ^

P.L. 96 511 ? (Check one)

Registration Certificate In Vitro Testing with Byproduct Material Under General License, JQ No tSection 3507 submission) 10 CFR 31.Il 2 O Yes, NPRM. Expected date of publication:

6. A. ls any mtormation coIIection (reportmg or recordkeepmg) 30 Yes.fsneltute. Expected date of pubhcation:

Involved? (Check one)

Effective date-

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D. At what phase of rulemaking is this submission made?

l t h Yes and proposal is attached for review

'(Check one)

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2 O Yes but proposalis not attached - skip to question D.

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3 D No -- skip to Question D.

1 $ Not applicable B. Ar] the respondents pnmanly educationalagencies or.

20 Maior rule.at NPRM stage l..

J instituisons oris the purpose related to Federaleducation 30 Major F6nal rule for which no NPRM was published ~

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4 O Major Final rule, after publication of NPRM O YJs

@ No 5O Nonmajor rule,at NPRM stage 6 O Nonmajor rulel at Final stage COMPLETE SHADED PORTION IF INFORM ATION COLLECTION PROPOSALIS ATTACHED

7. Currsnt (or foi mer) OMB Number

8. Requested.

12. Agency repors form number (s).

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Expiration Date

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3150-0038 NRC 483 EExpir tion Date

13. Are respondents only Federal agencies?(

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16. Classification of Change in Burden (explain in supporting statement)

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8112040082 811118" PDR ORG EUSOMg Stancard Form 83 (Rev. 3-81)

PDP For Use Beginning 4/1/81

17. Abstract-Needs and Uses (50 words ort;ss)

,PrOvides specific data for agency review in regard to in vitro testing with byproduct mat; rial.

18.R;tated report form (s) (give OMB number (s),IRCN(s)

20. Catalog of Federal Domestic Assistance Program Number I:t:rnalagency report form number (s) orsymbol(s)),,L_ _.,

N/A

21. Small business or organization (E Yes O No 19.Typ3 of aflected public (Check as many as apply)

22. Type of activity of affected public-indicate 3-digit Standard industrial Classification (SIC) code (s) (up to 10) - if over 1 O individuals orhousehotds to, check O Multiple or O All 2 O state orlocalgovernments 3 0 terms 0

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. 8 0 7 d)C1 businesses or otherinstitutions (except farms)

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' 23. Bri:t description of af fected public (e g.."retailgrocery stores."" State education agencies."" households in 50 largest SMSAs")

Physician. Clinical 1aboratorv. Hnenital ~ Votorinarian

24. Purpose (Check as many as apply. IIrisore thari one, in'dicate

26. Collection method (Check as many'as~ apply):W r& g mai1Eelf-adrniniste' red b.2%D'?

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25.Frsquency cf Use

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28. Authority for agency forinformation collection or

30. Do you promise confidentiality? 1 rulamaking-indicate statute, regulation, judicial decree.

(If yes, explain basis for ptedge -

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in supporting statement.)

_D Ye s...).No,'.

31 mi tne proposed information collection create a new or Atomic Ener97 Act of 1954' as amended become part of an existing Privacy Act system of records?

29. Rasponoent's obegation to repty ICheck as many as apply)

(If yes, attach Feoeral Register nctice or proposed craft of 1 % voluntary notice.)

O Yes Q( No 2 O required to COtain or retain benefit

32. Cost to Federal Government of 3 0 mandatory-cite statute,not CFR (attach copy of information collection or rulemaking S 16.000 statutory authority)

COMPLETE ITEMS 33 THRU 35 ONLY IF RULEM AKING SUBMISSION

35. ls there a statutory orJudicial

[34 ts there a regulatoryimpact

33. Compliance costs to the public analysis attached?

deadline affecting issuance?

O Yds O No O Yes. Enter date:

S O No CERTIFICATION BY AUTHORIZED OFFICI ALS SUBMITTING REQUEST-We certify that the information Collection o' rulemaking submitted for review is necessary for the proper performance of the agency's functions that the propesal represents the minimum public burden and Federal cost con %t;nt with need and is consistent with appheable OMB and agency policy directives. Signature and title of:

SpestovmG roLICv oFFiceAL Foe AGENCY DATE sueuiTTING orFICsAL DATE D

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Daniel Donoghue t stenhan srntt 4

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f SUPPORTING STATEMENT FOR FORM NRC 483, Registration Certificate-In Vitro Testing with Byproduct Material Under General License 10 CFR 31.11 Justification Section 31.11(a) of 10 CFR Part 31 provides. for a general license for the use of iodine-125, iodine-131, carbon-14, hydrogen-3, iron-59, selenium-75, and mock iodine 125 by any physician, clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine for the purpose of certain irt vitro clinical or laboratory testing. The general license sets forth the conditions pertaining to possession and use of the byproduct material.

Section 31.ll(b) specifies that in order for the physician, clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine to use the general license, Form NRC-483, " Registration Certificate - In Vitro Testing with Byproduct Material under General License" must be comple'ted and submitted to NRC.

The licensee must then receive a validated copy of the registration certificate with an assigned registration number to complete the licensing process.

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

Section 31.11(e) requires that a licensee under this section report in writing any change in a previously validated registration certificate.

The licensee must report the change to the NRC within 30 days after the effective date of such change.

The information derived as a result of the submission of the registration form provides 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 assures the NRC staff that the general licensee is aware of the terms and conditions prior to receipt of byproduct material.

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Information filed with NRC on the registration certificate is available only from applicants and is not otherwise available to the Federal Government.

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-Description of survey plan Approximately 425 registration certificates will be received annually from persons who wish to be general licensees under Section 31.11.

. Tabulation and publication plans 8

There are no plans to publish the information received from licensees pursuant to the recordkeeping and reporting requirements in Section 31.11 of 10 CFR n

-Part 31.

Time schedule for data collection and ' publication.

After initial registration, changes must be reported within 30 days after the effective date of such change. Changes are submitted in writing and, if approved, returned to the applicant utilizing the old registration number.

Initial registrations are processed and returned to the applicant within three days, changes are returned within two days.

Consultations outside the agency No consultations have been initiated since the last clearancc.

Estimation of compliance burden Experience has shown that completion.of the registration certificate accomplished in approximately seven minutes since it merely requires can be

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filling in the licensee's name and address, checking one of the classes of licensees, signing, and dating the certificate. Maintaining the validated certificate for display is an extremely small burden on licensees and changes to existing validated certificates are rare. The total estimated annual burden for all 425 licensees is approximately 50 staff-hours, 425 responses times 7 minutes.

Estimate of cost to the Federal Government Cost to the Federal Government is $16,000 which covers 400 staff hours required for review, approval, and issuance of the registration certificate.

Enclosure:

HRC Form 483 1

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'V'~T MW],n CCNDITIONS AND LIMITATIONS OFCENERA(LICENSE'10 CF231.11 w, f. :

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$31.11 Generallicense for use of bypreluct materials Lcense established by paragraph' ( )'of Abis section ~ (d) The general licensee sha!! not receive,icquire,

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for certain in v>tro chnacal or laborstory testang.

und! he has filed NRC Form 433 '"Registranon Cer-,

possess; er

• use byproduct material pursuant to 4

tificate-In vitro Testing with Byproduct Material paragraph (a)of thissection:

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(:) A general hcense is hereby issued to any physi-Under General License " with the Director of Nuclear (I) Except as prepackaged units which are labeled

-y cian, vetennarian in the practice of veterinary Matenal Safety and Safeguards, U.S. Nuclear in accordance with the provisions of a speific license medacine, cimacal laboratory or hospital to receive, Regulatory Commission Washington D.C. 20555, issued under the provisions of $32.71 of this chapter acquire, possess, transfer, or use, for any of the and received from the Commission a validated copy or in accordance with the provisaons of a specific followmg stated tests, in accordance with the prou-of NRC Form 433 with registration number assigned license issued by an Agreement State that authorizes saons of paragraphs (b), (c), (d) (e), and (f) of this or until he has been authorized pursuant to 135.14(c) manufacture and distribution of iodine-125, iodme-b section. the following byproduct materials in of this chapter to use byproduct matenal under the 131. carbon-14, hydrogen-3 (tritium), selenium-75, y

sencrallicense in this $31.11. The registrant shall fur-iron-59 or Mock lodme-125 for distribution to per-prepackaged units:

esceeding 10 nish on NRC Form 433 the following informat6n and sons generally licensed by the Agreement State.

O (1) lodine-123, in units not microcuries each for use la in vitro chnical or such other informadon as may be required by that (2) Unless the following statement, or a substan-N laboistory tests not involving internal or caternal ad-form:

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tally abr.ilar statement which contains the informa-

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,a ministration of byproduct material, or the radiation

. (I) Nameand addressof theregistrant;

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tion called fo.'in the following statement, appears on.

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.. a label affixed to each prepackaged unit or appears in.

therefrom, to human bems: or animals.

(2) Delocation of use,and "

(3) A statement that the re2 strant has appropriate ( aleaflet or brochure which accompanies the package:2 (2) todine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or radsadon measuring instruments to carry out in vitro

' This.radaoactive material may be received, ac-

-s 3-laboratory tests not involving internal or external ad ' r clinical or laboratory tests with byproduct materials ' quired., possessed, and used onlyby physicians," t 4 ? ' 'E i

4 ministration of byproduct material,' or the radiation. as authorned under the gen:rallicense in paragraph veterinarians in the practice of veterinary medicine,-

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(a) of this section, ard thet such tests will be per.

clinicallaboratones or hospitals and orily for in vitrt, '

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(3) Carbon-14, in units not exceeding to formal only by personnel competent in the use of._ clinical or laboratory tests not involving internal or'.

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microcuries each for use.in in vitro chnical or suchinstruments and in the handling of the byproduct - external administration of the materiaTor the radia ;

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& '. : tion. therefrom, to human beings.or ardmata Its 1

laborstory tests not involving internal or external ad-materials.

s nunistration of byproduct material, or the radiation.,4(c) A person who receives, acquires, possesses or. receipt, acquisition, possession, use, and transfer are.,

'M iherefrom,to human beings or animala.] ^

uses byproduct material pursuant

• to ' the general <. subject to the regulations and a generallicense of the (4) Hydrogen 3 (tritium). in units not e teeding 50, license estabhshed by paragraph (a) of this section T U.S. Nnet-r Regulatory Commission or of a State Q

..,g with which the Comminion has entered into an agree.

Qy microcuries each for use in in vitro tiinical or shallcomplywiththefollowing:

' 1Aoratory tests not involving internal or external ad ' ' -(1) The generallicensee slN not possess at any one.. ment for the eau -ise of regulatory authority, W

/ >"M ministration of byproduct material, or the radiation time pursuant to the general a. cense in paragraph (a) - ' U. E - g 4.r.

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- - -of this section, at any one location of storage or use, a, ~

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,M (5) fron 59, in unita vot exceedmg 20 microcuries total amount of iodine 125. iodine 131, selenium-75, M_4' Name of manufacturer +

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each for use in in vitro cnnical or laboratory tests not and/or iron 39 in excess of 200 microcuries.

lovc!ving internal or enternal administration of (2) The general licensee shall store the byproduct (e) The registrant possessing or using byproduct

'4 byproduct material, or the radiation therefrom, to material, until used, in the original shipping container materials under the generallicense of paragraph (a) of j

human beings or animals.

or in a container providir.g equivalent radiation pro.

tis section shall report in writing to the Director of 1

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c a al Safety and safeguards any chaL:n u) Selenium-75, in units not exceeding 10 (3) The general licensee shall use the byproduct a the information furnished by him in the "Registra-microcuries each for use in in vitro clinical or material nly f r the uses authorized by paragraph (a) tion Certificate-In Vitro Testing with Ilyproduct laboratory tests not involvmg internal or enternal ad-f this section.

Material Under General License " NRC Form 483.

muustrauon of byproduct material, or the radiauon (4) The general licwe shall not transfer the The report shall be furnished within 30 days after the therefrom, to human beinss or animals.

byproduct material except by transfer to a person effective datc of such change.8 authorized to receive it by a license pursuant to this (f) Any person using byproduct material pursuant ' -

(7) Mock lodme.123 reference or cabbrat on sources. tr. uruts not exceedmg 0 905 microcurie of chapter or from an Agreemut State,' nor transfer the to the general lic,mse of paragraph (a) of this section is 6adine-129 aad 0.00$ microcurie of americium.241, byproduct material in any saanner other than in the exempt from the requirements of Parts 19,20 and 21

y each for use in in vitro clinical or laboratory tests not ' unopened,-labeled shipping containei.as received ' ~of this chapter with respect to byproduct material

' ' ' "Y inzolving internal or caternal administration of -from the supplier." - "-*" -

covered by that general license,~chcept that such per-

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byproduct material, or the radiation therefrom, to (5) The genc+al licensee shtll dispose'of the Mo'c5 sons using the Mock ' lodine 425 tescribed in human beings or animals.

lodme-123 reference tr e-% ration sources decribed paragraph (a)(7) of this section shall comply with 'he (b) No person shall receive, acqui.e. possess, use or in paragraph (a)& of sm. section es required by provisions of $20.301, 20.402 and 20.403 of nis trusfer byproduct material pursuant to the general 120.301 of this chapter.

chapter.

NOTES

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A State to which ce: tain regulatory authority over radioacti<e material has been transferred by formal agreement, pursuant so section 274 of the x

Atomic Energy Act of 1954, as ame tded.

2 Material generally licensed under this section prior to Januart W,1975 may bear labels authorized by the regulations in effect on January 1, 1975.

3 A new triplicate set of this Registration Certificate, NRC Forn4U. may be used to report any change of information furnished by a registrant as required by Oi ll(e).

I 3/J/f,O R 313M.

If larger q. c.tities or other forms of b> product material than those specified in the generallicense of 10 CFR 31.11 are required, an " Application for B> product Material License " NRC Form 311. should be filed to obtain a specific byproduct inaterial license. Copies of application and registra-tion forms may be obtained from the United states Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Material Licensing Branch, Division of Fuel Cycle and Material Safety.

PRIVACY ACT STATEMENT Pursuant to 5 U.S.C. 522a(c)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the following statement is furnished to individuals who supply information to the Nuclear Regulatory Commission on NRC form 483. This information is maintained in a system os recorJs designated as N RC-3 and described at 40 Federal Register 45334 (October 1,1975).

1,'

AUTilORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C.2111 and 2201(b)).

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PRINCIPAL PURPOSE (S) The information is evaluated by the NRC stalf pursuant to criteria set forth in 10 CFR Parts 30-36 to determine whether the application conforms to the requirements of the Atomic Energy Act of 1954, ais amended, and the regulations of the ilRC, for the av-%

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_p1 p.3 e wr-W 3. < ROUTINE USES _ The information may be used: (a) to provide records to State health departments for their informat

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'~ provide informaticn to Federal, State, and local health officials and other persons in the event of incident or exposure for pt.rposes cf their in-Oi formation, investigation, and protection of the public health and safety.The information may also be disclosed to appre priate Federal, State, or

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local agencies in the event the information indicates a violation or potential violation of law and in the course of an administrative or judicial J,

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, M(if. proceeding, in addition, this 'nformation may be transferred to an appropriate Federal Statecor local agency

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S W/A LWIIETHER DISCLOSURE IS MANDATORY OR. VOLUNTARY AND EFFECT ON INDIVIDUAL 01 NOT.PROVIDING INFORMA-A:

Ld.Mm, TION. It is voluntary that you furnish the requested information. If the requested information is trot furn'shed, howevers the registration ect-

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l g g.: tificate, or amendment thereof, will not be processed,+ u -

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5. - SYSTEM MANAGER (S) AND ADDRESS Director, Division of Fuel Cycte and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission. Washington, D.C. 20555.

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RE21STRAT10N CERTIFICATE-IN ylTRO TESTIN3

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'f WITH BYPRODUCT MATERIAL UNDER~GENERALI.lCENSE' Section 31.11 of to CTR 31 establishes a general license authorizing physic *ans, clinical laboratories, hospitals, and veterinarians in the practice of veterinary medicine to possess certain small quantities of byproduct material for in vitro clinical or laboratory tests not involving the internal or external administration of the byproduct material or the radiation therefrom to human beings or animals. Ponession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine, has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with regis; ration number.

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3. I hereby apply for a registration number pursuant' to

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< J.u 131.11,10 CRF 31 for use of byproduct snaterials for s w

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O a." Myself, a duly licensed...ysician authdrized to dis.-

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W" pense drugs in the practice of medicine.

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O bl The above-named clinicallaboratory.

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nrq3 w L.w. 74 1 4.:To be completed by the Nuclear Regulatory Commission.-

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. W.:nsw.m. :- e r es-2 ? i.M INSTRUCTIONS

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- Cl. Submit this form in triplicate to:

Registradon number:,-.._

Office of Nuclear MaterialSafetyand Safeguards

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' ATTN: MaterialLicensing Branch U.S. Nuclear Regulatory Commission -

Washington. D.J. 20555 3

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2. Please print or type the name and address Oncluding zip codel of the registrant phpician, o,

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chnical laboratory, hospital, or veterinarian in the g

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practice of veterinary medicine for whom or for gg, mhich this registration form is filed. Position the fif this is an initial registration. leave this space blank - number to be first letter of the address below the left dot and do assigned by NRC. If this is a change of information from a previously '

5 not extend the address beyond the right dot. (At NRC, a registration number vill be assignsd and a : a registered generaliscense, includeyour registration number.)

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validated copy of NRC Form 483 will be returned.)

5. If place of useis different from address in Item I, please give complete address:

6. Certifgation:

I hereby certify that:

a.

Allinformation in this registration certificate is true and complete.

b.-

The registrant has appropriate radiation measuring instrur.ents to carry out the tests for which byproduct material will be used under the generallicense of 10 CRF 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.

c.

I understand that Commission regulations require that any change in the information f urnished by a registrant on this registration certificate be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the ef fective date of such change.

s d.

I have read and understand the provisions of Section 31.11 cf 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 general license for which this Registration Certificate is filed with the Nuclear Regulatory Commission.

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