ML20215M420

Request for OMB Review & Supporting Statement Re NRC Form 483, Registration Certificate-In Vitro Testing W/Byproduct Matl Under General License. Estimated Respondent Burden Is 30 H

ML20215M420
Person / Time
Issue date:	10/23/1986
From:	Norry P NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
OMB-3150-0038, OMB-3150-38, NUDOCS 8610300239
Download: ML20215M420 (8)

Text

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i w p u c p ,/' .7 q Sianda,d mm 83

-.~o Re4uest for 01B Review Important -

Read instructmns before e.ui.pr iing iorm Do not use the same SF 83 Send three copies of this form. the matenal to be reviewed, and for to request both an E secut've Order 12291 re view and approval under paperwork-three copies of the supporting statement, to the Paperwork Reduction Act Answer all questions in Port i, if this tr ;cest is for review under E.O Office of Information and Regulatory Affairs 12291. corvp'ete Pa't il and s.nn the regulatcry certification it this Office of Management and Budget request is for approvat under the Paperwork Reduction Act and S CFR Attention: Docket Library, Room 3201 1320. skip Part II. completo Part 111 and sign the paperwork certiScation, Washington. DC 20503 PART i.-Complete This Part for All Requests.

1. Department /a,;ency and Bureau /of fice origiriating request 2. Agency code U.S. Nuclear Regulatory Commission 3 1 5 0

3. Name uf hson who con best answer questrons regarding this request Telephone number Sterling Bell (301 ft27-9026

4. Title of infoirnation covection or ruieAking NRC Form 483 Registration Certificate - In Vitro Testing With Byproduct Material Under General License

5. L egt authorif y for intormation conec tron or rose (crte United States Code. Puoloc Law. or Enecutne Order) 42 osc .220l10) . or _ __

6. Af ferted pubk (check all that appfy) 5 0 rederaiagenciesor empioyees

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3 0 rarms s K] Non-profitinst>tutions i O ind-duais or housenoids 2 O state or tocai governments 4 LXJ Businesses or otrer for profit 7 10 Smati businesses or organizations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291 7, Regu'ation Iden f er Number (RIN)

_ _ _ _ . or. None assigned O S. T ype of submassion (check one in each categon) Type of review requested Cl.:ssification Stage of development 1 C Standard 1 O uaior 1 O eroposed or draft 2 Pending 2 C Nonmajor 2 C Finalorinteremfina!,withpoor proposal 3 0 Emergency 4 ' Statutory or judicial deadhne 3 O Final or interim final, without pnor proposal i

9. CF R section atfected CFR

10. Does this regulation contain report ng or recordi.eepm; requrements that require OMB approval under the paperwork Reduction Act are 5 CFR 13'0? . O vet O Nn

11. If a major rute. is the>re a regutatory impact anai>s.s attacheo 1 O Ves 2 O No

!! 'No." did OMB waeve the ana!yses? 3 0 ves 4 O No Csrtification for Regulatory submissions in submitting this request for OMB review, the author' red regv!ator, i ontact and the program of fic tal certJy that the reqSremer'ts of E O.12291 and any apphcable pohcy directives have been comphed voth. - ~~

Date Smnature of program o*ficial 8610300239 861023 S$natee o' authorized reyuf atory contact

- PDR ORG EUSOMB - --

PDR Date

12. (OMB use only) f%eoce ed te otwete g g gg staridard Form 83(N 9 8lj P'm W d r s U.'8 N ff " .:0 00 t 34 a(134 5 CF 41320 aM E O 12h1

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

13. Abstract-Descnbe needs. uses and affected pubhc in 50 words or less "Radioactf ve 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 submitting NRC Form 483. The certificate when validated by NRC, serves as evidence to suppliers of byproduct material that the registrant

_is_ entitled to recniva tho :natorial.

14. Type of information collection (check only one) information collections not contained in rules 1 @ Regular submission 2 O Emergency submission (cert,ficationartehed)

Informstlon collections contained in rules 3 0 Existing regulation (no change proposed) 6 Final or intenm final without pnor NPRM 7. Enter date of expected or actual Federal 4 O Notice of proposed rutemaking(NPRM) A O Regular submission Register publ+ cation at this stage of rulemaking 5 0 rinai. Neau was previousir pubhshed B O Emergency submission (cerfst,catton attached) (month, day, year):

15. Type of review requested (ctch only one) 1 O New coii ction 4 0 Reinstatement of a previously approsed collection for which approval has expired 2 O Revision of a currently approved collection 3 @ Extension of the expiration date of a currently approved collection 5 O Existing collection in use without an oMB controt number without any change in the substance or in the method of collection

16. Agtncy report form number (s)(nnelude standard /optronal form number (s)) 22. Purpose of information collection (check as many as apply)

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

17. Annuai reporting or disclosure burden 3 0 ceneraipurposestatistics 1 Number of respondents . 250 4 0 Regulatoryorcomphance 2 Humber of responses per respondent I 5 0 Program planning or management 3 Total annual responses (kne 1 times Irne 2) 250 s O Research 4 Hours per response 0.120 7 O Aud't -

5 Totai hours (Irne 3 tomes fine m 30

18. Annual recordheepir'g burden 23. Frequency of recordkeeping or reporting (check alltt,at apply) 1 Number of recordkeepers 1 O Recordkeeoing 2 Annua! hours per recordkeeper. ReParfi"K 3 Total recordkeeping hours (hne I times hne 2) 2 O onoccasion 4 Recordkeeping retention penod years 3 0 weekiy

19. Total annual burden 4 0 uontniy 1 Requested (hne 17 5 plus hne JBJ) . 30 5 0 Quarteriy 2 in current oMB inventory 30 s O semi annuaiiy 3 Difference (hne f less hne 2) 0 7 O AnnuaVy Esplanation aldifference 8 0 Biennially 4 Prcgram change 9 0 other(desenbe): One timo 5 Adjustment .

20. Current ('nost recent) oMB control number or comment number 24. Respondents' obhgat:on to comply (check the strongestobhgation thatapplier)

E0-00E

21. Regoested empiration date 1 O voluntary 2 O Required to obtain or retain a benefit 3 years from aoproval date 3 0 Mandatory 25.'Are the respondents primarily eoucational agencies or institutions or is the pnmary purpose of the collection related to Federal education programs? O ves @ No

26. Does the agency use samphng to select respondents or does the agency recommend or prestnoe the use of samphng or statistical analysis by respo9 dents? . O ves G No

27. Regulatc ry authority for the information collection 10 _ cFR 3l ll(h)  : or __ ___ FR  ; or,Other (spec:fy):

P; perwork Certification in submitting this request for oMB approval, the agency head, the senior official or an authonzed representative, certifies that the requirements of 5 CFR 1320, the F'nvacy Act, statistical standards or directives, and any other apphcable information pohcy directives have been comphed veth

$ignature of progr3m official Date Lgnature of agency head, the senior official or an authonzed representat.ve Date Patricia G. Norry, Director Office of Administration M4 s 8 MN

(_GPO_i_J R4 O_; 453 776_______ _

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Supporting Statement for NRC Form 483 Registration Certificate In Vitro Testing with Byproduct Material Under Ganeral License (10 CFR 31.11)

Justification Need for the Collection of Information 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 veteri-narian in the practice of veterinary medicine for the purpose of certain in vitro clinical or laboratory testing. The general license sets forth the conditions pertaining to possession and use of the byproduct material.

Section 31.11(b) specifies that in order for the physician, clinical 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 i

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

2 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.

Agency Use of the Information 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 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 Burden Through Information Technology There are no legal obstacles to reducing 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 Federal Information Locator System was searched to determine NRC and other Federal agency duplication. None was found.

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Effort to Use~ Similar Information There is no similar information available to the NRC.

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 byproduct 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 f.

businesses by less frequent or less complete submittal.

h Consequences of Less Frequent Collection NRC Fonn 483 is only submitted once, for initial registration.

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 None.

Sensitive Questions None.

4 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 seve, 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 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.

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 $60 per hour, the annual cost to the Federal government 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 $3,750.

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e NRC Form 483 U.S. NUCLEAR REOULATORY COMMIS$10N Approved by OMB 5 m 3S 10 CFR I REGISTR ATION CERTIFICATE-IN VITRO TESTING WITH 8YPRODUCT MATERIAL UNDER G ENERAL LICENSE Section 31.11 of 10 CFR 31 establishes a genera! license authorizing physicians. clinical laboratcries, hospitals, and veterinarians in the practice of veterinary medicine to possess certain smali quantities of byproduct material forin vitro clinical or laboratory tests not invohing the internal or external administration of the byproduct material or the radiation therefrom to human beings or animals. Possession 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 433 with registration number.

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3. I hereby apply for a registration number pursuant to (31.11,10 CRF 31 for use of byproduct materials for (pleasecheck one block only)

G a. Myself, a duly licensed physician authorized to dis-pense drugs in the practice of medicine.

O b. The above-named clinicalla'> oratory.

O c. The above-named hospital.'

C d. Veterinarian in the practice of veterinary medicine.

4. To be completed by the Nuclear Regulatory Commission.

INSTRUCTIONS '

l. Submit this form h triplicate to: Registration number:

Office of Nuclear MaterialSafety and Safeguards ATTN: Material Licensing Branch ,,%

U.S. Nuclear Regulatory Commission o Washington. D.C. 20555 g

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2. Please print or type the name and address 5 [

(including zip code) of the registrant physician, clinicallaboratory, hospital, or veterinarian in the practice of veterinary medicine fot whom or for e.,,e irst etter of ea rs ow t e f d t and d (if thu u an inidai ngurmdon, W thu space blank - nunsber to be not extend the address beyond the right dot. (At 8YI"## 07 II#AI# U # #A#"I' #II"I#""#N#"I""' # ### #"# 7 NRC, a registration number will be assigned and a registeredgenerallicense, utcludeyour registration number.)

validated copy of NRC Form 483 mill be returned.)..

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

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6. Certification:

I hereby certify that:

a. A!! information 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 general license of 10 CR F 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 unders'and 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 effective date of such change.

d. I have read and understand the provisions of Section 31.11 of NRC regulations 10 CFR 31 (reprinted cn the reverse side of this form); and I l 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 the Nuclear Regulatory Commission.

i Date By I

Printed name and title or position of person fding form

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WARNISG- Is U.S.C.. Section 100l; Act of June 25,1948; 62 Stat. 749; makes it a criminal offense to make a willfully false statement or representation to any department or agency of the Un! ed States as to any : natter within its jurisd.ction.

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a CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11 833.11 General hcense for use of b) product materish hcense estabhshed by paragraph (a) of this section (d) The general licensee shall not recene, acquire, for certain in sitro cimical or laboraiory testing. until he has filed NRC f orm 483, " Registration Cer. poness, or use byproduct material pursuant so tificate-In %tro Testing with Byproduct Material paragraph tal of this section:

(a) A generaligense is here5 issued to an) physi. Under General License," with the Director of Nuclear (1) Encept as prepackaged units whgh are labeled cian, veterinarian m the practice of veiermar) Malenal Safeiy and Safeguards, U.S. Nuclear in accordance with the prosisions of a specifw hcense medicme, cimical laboratory or hospital to recene. Regulaiory Commission, W ashington, D.C. 20555. issued under the provisions of (32.71 of this chapter acquire, possess, transfer, or use, for an) of the and recened from the Commnsion a sahdaied copy or in accordance with the prousions of a specific follooms stated tests, in accordavice niih the prosi. of NRC f orm 483 with registraison numoer assigned hcense issued by an Agreement State that authorues siens of paragraphs (b), (c). Id), tel, and (f) of thn or unist he has been authorned pursuant to $35.14(c) manufacture and distnbution of iodme 125, iodine-section, the following b> product maieriah in of thn chapier to use b) product material under the 131, carbon-14, hydrogen 3 tintium), selenium 75, c'epackager units: general license in this (31.11. The registrant shall fur- iron-59 or Mock lodme 125 for distnbution to per.

(!) Iodine 125, in units not encredmg 10 nish on NRC f orm 433 the following information and sons generally licensed by the Agreement State.

murocuries each for use in in sitro chnical or such other information as may be required by that (2) Unless the following statemetit, or a substan-laboratory tests not msohms miernal or enternal ad- form: tially similar statement which contams the informa-mmistration of byproduct material, or the rabation (1) Name and address of the registrant; tion called for in the following statement, appears on therefrom, to human bemgs or animals. (2) The location of use; and a label affiaed to each prepackaged unit or appears m (2) lodine 131, in units not enceeding 10 (3) A statement that the registrant has appropriate a leaiset or brochure which accompanies the package) microcuries each for use in in vitro chnical or radiation measuring instruments to carry out in vitro This radioactive material may be recened. ac-laboratory tests not involving mternal or esternal ad- cimical or laboratory tests with byproduct materials quired, possessed, and used only by physicians, mmistration of byproduct material, or the radiation as authorued under the generallicense in paragraph veterinarians in the practice of veterinary medicme, therefrom tc human besgs or arsimals. (a) of this section, and that such tests will be per. chnical laboratories er hospitals aH on'y for in utro (3) Carbon 14, in units not enceeding 10 formed only by personnel competent in the use of chnical or laboratory tests not involving internal or microcunes each for use in in vitro chnical or such instruments and in the handimg of the byproduct external administration of the material or the radia-tabiratory tests not involving internal or enterna! ad- materials. tion therefrom, to human beings or animals. Its ministration of byproduct material, or the radiation (c) A person who recenes, acquires, possesses or receipt, acquisition, possession, use, and transfer are therefrom, to human beings or animals. uses byproduct material pursuant to the general subject to the regulations and a generallicense of it e (4) Hydrogen 3 (tritiuml. in units not exceeding 50 hcense established by paragraph (a) of this section U.S. Nuclear Regulatory Commission or of a State microcurses each for use in in vitro chnical or shall comply with the following: mith w hich the Comrmssion has entered into an agree-laboratory tests not invohing internal or enternal ad. (1) The general hcensee shall not possess at any one ment for the exercise of regulatory authority.

mmistration of byproduct material, or the radiation time, pursuant to the generallicense in paragraph (a) therefrom, to human bemgs or animals, of this section, at any one location of storage or use, a .... ....

total amount of iodme 125, iodme 131, selenium 75, ....Name of manufacturer (5) Iron 59, in 6 nits not exceedmg 20 microcurie, each for use m in vitro chnical or laboratory tests not and/or iron 59 in excess of 200 microcuries.

(2) The general hcensee shall store the byproduct (e) The registrant possessing or using byproduct insolving internal or es:ernal administration of byproduct material, or the radiation therefrom, to material, until used, in the original shipping container materials under the general hcense of paragraph (a) of or in a contamer providmg equivalent radiation pro- this section shall report in writing to the Director of human bemgs or animals.

secti n. uc ear atenal a and Safeguads any chanan n) Selenium-75, in units not exceedmg to (3) The general hcensee shal1 use the byproduct in the information furnished by hirn en the "Registra-microcurses each for use in in vitro cimical or "'*" #"'I " * * " '"

E * 8 ' " #* ' " ' pduct taboratory tests not involving internal or enternal ad- of this section. Maierial Under General Lkense 3 a33.

NRC Form mmntration of byproduct matenal, or the radiation (4) The general heensee shall not tre.nsfer the The report shall be furnished within 30 days after the therefrom, to human bemgs or arumals. b> product material except by transfer to a person effectise date of such change.5 (7) Moch lodme 125 reference or cahbration authorued to receive it by a license pursuant to this (f) Any person usms byproduct material pursuaat sources, in units not exceedmg 0.005 microcune of chapter or from an Agreement State,' nor transfer the to the general hcense of paragraph (a)of this sectionis iodme.129 and,0.005 murocune of amencium.241 byproduct material in any manner other than in the enempt'from the requirements of Parts 19,20 and 21 each for use in in vitro clinical or laboratory tests not unopened, labeled chippmg container as receised of this chapter with respect to byproduct matenals insolving internal or enternal administration of f rom the supplier, covered by that genera!Inense. encept that such per.

typroduct material, or the radiation therefrom, to (5) The general heensee shall dispose of the Mxk sons usms the Mock lodme-125 described in human bemss or animals. lodme.125 reference or calibration sources decnbed paragraph (a)(7) of this section shall comply with the (b) No person shall receise. acquire, possess, use or in paragraph (a)(7) of this section as required by provisions of (20.301, 20.402 and 20.403 of this transfee byproduct material pursuant to the general (20.301 of this chapter, chapter.

NOTES 3 A State to which certain regulatory authority oser radioactive material has been transferred by formal agreement, pursuan: to section 274 of the Atomic Energy Act of 1954, as amended.

2 Material generally licensed under this section prior to January 19,1975 may bear labels authorized by the regulations in effect on January 1, 1975.

3 A new triplicate set of this Registration Certificate, NRC Form 483, may be used to report any change of information furnished by a registrant as required by {31.ll(e).

If larger quantities or other forms of byproduct material than those specified in the generallicense of 10 CFR 31.11 are required, an "Applica-tion for Byproduct Material License," NRC I orms 3131,313M, or 313R should be filed to obtain a specific byproduct materiallicense. Copies of application and reFi stration forms may be obtained from the United States Nuclear Regulatory Commission, Washington, D.C. 20555, Attention:

Material Licensing Branch, Daision of l~uel Cycle and Material Safety.

PRIVACY ACT STATEMENT Pursuant to 5 U.S C. 522 ate)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the following statement is fur-nished to individuals uho supply information to the Nuclear Regulatory Commission on NRC Form 4S3. This information is maintained in a system of records designated as NRC 3 and described at 40 Federal Register 45334 (October 1,197!).

1. AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 220ltb)).

2. PRINCIPAL PURPOSE (S) The information is evaluated by the NRC staff 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, as amended, and the regulations of the NRC, for the issuance of a registration certificate authorizing the use of in vitro testing

3. ROUTINE USES 1he information may be used. (a) to pauside tesoids to State healti. departrrcr,ts for their infcr::::ic::::d me;:nf (t) e provide information to Federal, State and local health of ficials and other persons in the esent of incident or exposure for purposes of tLear in-formation, ins estigation, and protection of the public health and safet). The information may also be disclosed to appropriate Federal State, or local agencies in the eseni the information indicates a siolation or potential siolation of law and in the course of an admimstratise or j.idicial proceeding, in addition this mformation ma) be transferred to an appropriate Federal State, or local agency to the estent rtlesant and necessary for an NRC decision or to an appropriate F ederal agenc) to the extent relesant and necessar) for that agency's decision about you.

4 WHETHER DISCLOSURL 15 M ANDATORY OR VOLUNT ARY AND EFFECT ON INDIVIDU AL OF NOT PROVIDING INFORMA.

TION 11 ts voluntary that you f urnish the requested information. If the requested mformation is not furnished, hom eser, the registration cer.

tificane, or amendment thereof, will not be procewed.

5. SYSTEM M ANAGERtSi AND ADDRISS Director Dnision of Fuel Qcle and Ma'erial Safet) Offne of Nuclear Matenal Safca and Safeguards U.S. Nuclear Regulator) Commission, % ashingion D.C. 20555.

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