ML20127F596

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

ML20127F596
Person / Time
Issue date:	01/12/1993
From:	Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0038, OMB-3150-38, NUDOCS 9301200299
Download: ML20127F596 (8)

Text

% - .

] [] . , t fL) g, 1:

~~d"* 8 8 Request for 0MB Revlea

(%v $.pomter 198h - ]g  ;

important  ;

Road instructions before completing form. Do not use the same SF 83 Send three copies of this form, the mateHal 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, Ancwer all Questions in Part 1. If this request is for teview under E O. Office of Information and Regulatory Aff airs 12291, complete Part il and sign the regulatory certification. If this Office of Mar:agement and Budget teovest is for approval under the Paperwork Reduction Act and S CFR Attention: Docket Ubrary, Room 3201 1320, Skip Part it, complete Part til and sign the paperwork certification. . Washington, DC 20503 ,

eAtlT l.-Complete This Part for All Requests.

1, Departme. wgency and oureauf off a or:sinating rcomt 2. Asency code -i U. S. Nuclear Regulatory Commission 3 .1. 5 0

3. Name of person who can best answer questions regarding thts request Telephone number Michael'Lamastra 1 (301 ) 50/-3416 i ,

4. Title of intof mation conection or ruiemakmg NRC Form 483 Registration Certificate - In11trolestinguWith10yprdduct"N&tersal Under General License i

5. Legai author:ty ior inf or mation conection or rule (cire (>nded States Code. Pubhc Lan, or Iaccutive Order) ,

42 use 2201(o) .,,

__ l

6. Affected public (check allthat 4001)) $ @ rederalagenciesoremployees .

1 O Indmduals or households - 3 0 rarms 6 W Non profit institutions 2 O stateoriocaieovernmenti 4 W ausinesses or other for prot't 7 W smatibuimessesorersantiatens PART ll.--Complete This Part Only if the Request is for OMB Review Under Executive Order 12291 ,

7. Regulaten Identdier Number (RIN)

_ _ _ ~ - - _ _. or. None assigned C

8. Type of submussio5 (check orie on each category) type et review requested Cisssification - Stage of development 1 O standard 1 O uaio, i O proposedororatt 2 O pending 2 O Nonmaior O rinaior mtenm iinai, w in ivior proposa> 3 0 cmergency  ;

3 0 rinai or inteom finai. witnout enor proposai 4 0 ststutoryorludiciaidesdime

9. CF R sect on aff ected CFR

10. Does this regulatiori contain reporting or recordxceping reauirements that require OMB approval under the Paperwork Reduct@n Act 1

- and 5 crR 13207 . . . . C Yes O No

11. If a maior rule,is there a regulatory impact analysis attached? , .

,1 O ves - 2 O No It"Nof'_did OMB waive the anajysis' 3 0 ves 4 D No *

- C rtification for Regulatory Submissions in submitting this request for OMB review. the autnorised verutatory contact and the progeam official certify that the requirements of 00; 12291 and any apphcable

. pokey directives have been comphed with.

$cgnature of program official Date 5$r at are of autnonted regJatory contact Date -

' 12. (QMB use only)

Prewous co+tes oesnete g3 395 ig - Standers torm smew 9 BU -

LNW 7fA&oo43a 403a T.'

Prescnted t'y oMB -

s CF R 1)?Q and E.C 12291 9301200299-930112 u/

PDR .ORG~ EUSOMB .. L PDR. W> ) I

.m ,-,,- --,-,,,

,,.,n_~_.,,.,._n _ , . , . , , . . . . , , , , _ _ , , _ _ _ ._ _ , , ,_

MART lli,-Complets This Part Onlyif the Requ:st is f t Approvalcf a Cellsetian  ;

of information Under the Paperwork Reduction Act and 5_CFR 1320.

"k.adioactive Abstract-Descrit+ Materianeeds. ssuseland Radiation affected pubbc on 50 woros or less Safety" Jersons wishing to use radioactive byproduct material for in vitro clinical or laboratory -

testing under the general license in 10 CFR 31.11 must register with NRC by submitting -

1RC Form 483. The certiffcate when validated by NRCs serves as evidence to suppliers of s

ayproduct material that the reaistrant _is entitled to receive the material.

,4. T ype of informaten collecten (check only one) informstlen collections not contained in rules 1 @ Regular submission 2 O tme<gency submissen(certiricat>oriarrached> l I

Information collec tions contained in rules 3 O taistmg reguiaison (no chanse oroposed) s rmai or inte,im finai w,thout p,4o, Neau 7. tnier data of e,pected o, actuai redersi 4 O Notice of proposed ruiemaking(NPRM) A O neguiar subm4uon aegister pubhcation at this stase of ruiemaking 5 O rinai. upau *as prevousiy pubiished B O tmergency submas on (cerer'> cation attached; tmonth,dar > ear)-

5. Type of rev.ew requested (chec& only one) ,

1 O New collection 4 O Reinstatement of a previously approved collecta for which approval 2 O Revision of a currentir approved coli ction "*'"*

3 $ tatenuon of the empiration date of a currently approved cohection 5 0 tx4 ting coiiection m use without an ouo controi riumber without ans hagm the substance tw in the method of conecten

% Agency teport form number {s)(mclude standardfoptsonalform number (s)) ll Purpose of information coIftction { check as many as apply)

O Appocatenior benehts NRC Form 483 2 O Program evaluat on i7. Annual reporting or o sclosure burden 3 C Generalpurpose statistics 1 Number of respondents . 250 4 LXJ neguistoryorcompnance 2 Number or responses per respondent I .. 5 O Prtyram planning or management 3 Total annual responses (lme j times hoe 2) -250 e O Research 4 Hours per response ,

0,120 7 O Audit

_,}J2tal hours (hne 3 times !rne di 30

18. Annual recorokeepmg butden 23. F requency of recorakeepmg or reporting (checA a/I that apply)

! Numter of recordkeepers 1 O pecordkeepmg 2 Annual hours per recordkeeper. Reportins 3 Total recordkeepmg hours (hne J tmies I;ne 2) 2 O onoccasion -

4 Recordbeeoing tetention pered years 3 0 weekiv

19. Total annual butden 4 O uonthiv 1 Requested (hne 17 5 plus hne 18J) . 30 s O ouarterly -

2 in current oMB mventory ,

30 s O someannu.or 3 oitteience (hne J less Ane 2) 0 7 O Annuaiiv

. Laptenation of difference _e O aiennia\ny 4 Program change 9 0 other(desersbe): QIle time 5 Adjustmer't .

24. Respond 6nts' obligation to comply (checA the sfrongest obhgation that apphes)

20. current (most recent) oMB controi number or comment number 3150-0018 i O voontary

. 21. Raqueted expir iion dat* 2 K1 aequired to obtain or retam a ben.ht +

L 3 years from approval hie ) '. J Mandatory r - 25. Are the respondents primanly educational agencies or institutions or is the primary p pose of the collection related to rederal education programsr O ves G No - l 2'6.- byDoes the agenef use samphog to select...respondents or does the agency recomme id w prescribe the use .ofOsamphng respondents ,, . . vei 0 No or stat l-

27, Regulatory authority for the information cohetten 10 CrR 31 11(bl ;or -.FR  ; or.other(specify)

__

Pcpstwerk Certificatk>n _

In submittmg this request for oMB approval, the agency head, the p- er otheial or an authorized itpresentative, certifies that the requirements of 5 CrR 1320, the -

Drivacy Act. statistical standards or directives, and any other apphcab, mformaten pokey directive' .iave been comphed with, Signature or program othcial Date s

~re esentative te

_{

s< r a d. se heial or an aut .

d ".ene or signa Sen[or.;0f ficial - , g yn2,18%-  ;

,, ,Q. %.: fon gement: ~ "

f '

8 \

(/ - 1

• cro (1984 o - 453-776 ;

9. . ;. . &

. - - - _ - _ . . _ ..,.;-. u ... ~ , _

_.1 -. _ . _ . ~ . _ - - . , , _...._..-,,_- - , _ - , ,

Supporting Statement for NRC form 483 Registration Certificate in Vitro Testing with Dyproduct Material Under General License 10 CFR 31.11  !

(3150-0038)

Dug d p11RD_Af_the_ I n f o rm at i o n C o l l e c t i o n Section 31.11 of 10 CFR part 31 establishes a general license for the use of- '

byproduct material for the purpose of certain in YJ1tn clinical or laboratory testing. NRC form 483, the registration certificate, contains the terms and conditions of the general license and provides a means of. assurance to the NRC that the general licensco is aware of those terms and condittom prior to ,

receipt of byproduct material.

A. dyntftcALign Herd for the Collection of In[91Rd100 Section 31.ll(a) of 10 CFR part 31 provides for a general license for the use of lodine-125, lodine-131, Carbon-14 Hydrogen-3, Iron-59, Selenium-75, and mock lodine-125 by any physician, clinical laboratory, hospital, or veteri-narian in the practice of veterinary medicine for the purpose of certain in yltro 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-voterinary medicine- ,

to use the general license, NRC form 483, " Registration Certificate - In Vitro lesting with Byproduct Material Under General License," must be completed 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.voterinary medicine is a general licensee authorized to-receive the byproduct material.

Section 31.ll(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 af ter the effectivo date of such change.

Aggngy A e of the InformatiLD, 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 Throuah Information Technology There are no legal obstacles to reducing the burden associatt d with this information collection. Registrants may use electronic information processing systems to prepare and submit the required information.

Effort to identify Dupjication The Information Requirements Control Automated System (IRCAS) was searched to determine duplication. None was found.

Ef fort to Vse Similar Information There is no similar information available to the NRC.

(( fort to Reduce Small Busingis 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. iberefore, it is not possible to reduce the burden on small businesses by less n equent or less complete submittal.

(2n!3tgttences of less frecuent Collection NRC Form 483 is only submitted once, for initial registration.

Citqqm_slances Which Justifv lariation from OMB_qgidelinn There are no variations from OMB guidelines.

Cgplultations Outside the Aaency There have been no outside consultations since the previous clearance.

Confidentiality of Information t

None.

Sensitive Questions None.

2

q i

?

Estimate of Comoliance 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 clerical function, the cost is estimated to be approximately

$45 per hour. The total cost for preparation of the 250 certificates would be approximately $1,350. o 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 $123 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 $7,687.50.

Source of Burden Data and Method of Estimatina Burdgn l Burden and cost estimates are based on the number of registration certificates '

received by NRC annually in previous years and on staff experience.

Reasons for Chance in Burden There is no change in burden. ,

Publication for Statistical Use None.

B. Collection of Information Employina Statistical Methods Statistical methods are not used in this collection of information,

+

3-

(7590-01]

NUCLEAR REGULATORY COMMISSION I

Documents Containing Reporting or Recordkeeping Requirements: Office of Management and Budget Review-AGENCY: Nuclear Regulatory Commission ACTION: Notice of the Office of Management and Budget review of-information collection. ,

SUMMARY

The Nuclear Regulatory Commission (NRC) has recently submitted to the Office of Management and Budget (CMB)- for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

1. Type of submission, new, revision, or extension: Extension.

2. The title of the information collectioni NRC form 483 Registration Certificate - In Vitro Testing With Byproduct Material Under General License

3. The form number if applicable:

NRC Farm 483

4. How often the collection is required: Once, when registering as a general licensee pursuant to li, rid Section 31.11.

5. Who will be required or asked to report: . Physicians, clinical laboratories, hospitals, &nd veterinarians in the practice of veterinary.

medicine wishing to use byproduct material for in vitrofclinicalior laboratory testing under the general license in 10 CFR Section 31.11.

t-

~

e m --

, -N__,,-. ,y ,N,,_-. p ....l, ,,!.,7_.4 ,

2 e

6. An estimate of the number of responses: 250 ,

7. An estimate of the total number of hours needed to complete the requirement or request: Approximately seven minutes per response. The total industry burden is 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> annually. ,

8. An indication of whether Section 3504(h), Pub. L.96-511 applies:. ,

Not applicable.

9. Abstract: Persons wishing to use byproduct material for in vitro clinical or laboratory testing under general license must register with NRC by :ubmitting NRC form 483. The certificate, when validated and returned by NRC, serves as evidence to suppliers of byproduct material that the registrant is entitled to receive the byproduct material.

4 Copies of the submittal may be inspected or obtained for a fee from the NRC Public -

Document Room, 2120 L Street, N.W. (Lower Level), Washington, DC.

Comments and questions may be directed by mail to the OMB reviewer:

Ronald Minsk Office of Informatica and Regulate'y Affairs (3150-0038)

NE08-3019 Office of Management and Budget

-Washington, DC 20503-Comments may also be communicated by telephone at (202) 395-3084.

c - . .=. .. . . - . - . - ....-..:=.. -.- .- .- . u. - . .. . :-.:-:1- . -

3 i i

i The NRC Clearance officer is Brenda Jo. Shelton, (331) 492-8132. .

Dated at Bethesda, Maryland, this / Sk day of'sM 19 17; for the Nuclear Regulatory Commission ,

4 h , fg G _

/ g 3

Gerald F. Cranford 5-Designated Senior Official for Information Resources Management i.

i 4

i l

r i

t.

.t i.

I 1

J l.