ML20039C978

Request for OMB Review & Supporting Statement Re NRC Form 482, Registration Certificate - Medical Use of Byproduct Matl Under General License. Estimated Respondent Burden Is 2-h

ML20039C978
Person / Time
Issue date:	12/14/1981
From:	Donoghue D, Scott R NRC OFFICE OF ADMINISTRATION (ADM)
To:
Shared Package
ML20039C975	List: ML20039C974 ML20039C976 ML20039C978
References
NUDOCS 8112310165
Download: ML20039C978 (6)

Text

j REZUEST FOR CMB REVIEW b

(Und:r ths P p;rwork R: duction Act and Encutive Order 12291)

Imp;rt:nt - Read instructions (SF-83A) before completing this Office of Information and Regulatory Affairs form. Submit the requirednumber of copies of SF-83 together Offsce of Management and Budget witn th3 material for which review is requested to:

Washington, D.C. 20503

1. D:partment/ Agency and Bureau / Office originating request

3. Name(s) and telephone number (s) of person (s) who can best answer questions regarding request U.S. Nuclear Regulatory Commission R. O'Connell (3DM 427-4211

2. 6-dicat Agency / Bureau number (first part of 11-digit Treasury

4. 3-dignt functional cou.o (lastpart of 11-digit Treasury Account Account No.)

No.)

.3_ _L _0_ _2. _n _fL

_2_ _l _ft

5. Tstis of Information Collection or Rulemaking C. Is this a rulemaking submission under Section 3504(h) of Registration Certificate - Medical Use of P.L 96-5117 (Check one)

Byproduct Material Under Gene'ral License Q No(SecUon 3507 submission) 2 0 Yes. NPRM. Expected date of publication:

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6. A.is anyinformation collection (reporting orrecordkeepang) 3 0 Yes. tinal rule. Enpected date of pubIncation:

l involved? (Check one)

Effective cate:-

l 1 Q Yes and proposat is attached for review D. At what phase of rulemaking is this submission made?

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

3 O No - skip to Question D.

1 Q Not applicable B Ars the respondents pnmanly educationalagencies or 20 Maior ru'e.at NPRM stage institutsons oris the purpose related to Federaleducation 3 O Major Final rute for which no NPRM was published programs ?

4 O Major Final rule. af ter publication of NPRM O yes Q No 5 O Nonmajor rule,at NPRM stage 6O Nonmajor rule at Finalstage COMPLETE SHADED PORTIONIFINFORMATION COLLECTION PROPOSALIS ATTACHED

7. Current (or former) OMB Number

8. Requested

12. Age,ncy r_eport form number (s),_

3150-0022

-Expiration Date~

NRC 482

~ ~"

Expir tion Date

13. Are respondents only Federal agencies? -

. ~., -.... - -.

2/28/82 2/85 O yes

)O No >

9. Is proposed information collection listed in

14. Type of request (Check one) -

th3 information collection budget?

E Yes O No

10. preliminary plan

10. Will this proposed snformation collection 2 0 new (notpreviouslyapproved or expired more than 6 mcnths I

1 cause the agency to exceed its information fago) coll:ction budget allowance? (llyet. 3ffach O Y5s - ('No a O' revision smsndment reauest from agency head.)

4 X extension (adjustmenttoburden only).

5 O extension (no change) ',,

11. Number of report forms submitted for approval 6 3 '* instatement (*"p"ed "' thin 6 months) one (1) 15.

16. Classification of Change in Burden (explain in supporting statement) e Appronmate size of i

unersrs, r,'samp,ei N/A No. of Responses.

No. o' R rporting Hours Cost to the Pubhc N/A aaninqntory:

200 17 b sinersampie s

a l I c. Estim;ted number of

b. As proposed 20 2

5 l'

resoondents or

, - record keepers per year 20

c. Difference (b-a) 180 15 5

i h Reports annuatry by each Explanation of difference (indicate as many as appfy);

j p. respondent (, rem 251

]

T

- ~j I

i l t Adjustments...

,4 s

o-l f a Tou annuairesoonses

' },'horrection-error

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> = f,thm tSc s 15dl

^

e.Co'rrection'feNstimati i$)

180 15 iS

f. Estim:ted everage k numberof hours

f. Change $use I

i i8 l

r perrxsoonse'iz~

^08-Program changes.9'

~

~

5 I

I' L

~ g Estem tedtotelhours m

[ of(nnual burden en

9. Increase

+

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+S Fisc 1 YIsr i

r, rem f 5n ts" 2

h. Decrease

-S lDRORG112310165 e11215 Standard Fonn 83 (Rev. 3-8 O EUSONS For Use Beginning 4/1/81 l

eno

17. Aber ct-Nnds cnd Us:s (50 words ogI:ss) rProvides basic data to cert'ify the idedi' cal use of byproduc't materials.

18. Ril:12d report form (s) (give OMB number (s),IRCN(s),

20. Catalog of FederalDomestic Assistance Program Number int:rnal agency teport form number (s) or symbol (s))_ _,...

N/A

21. SmaH business or organhation O Yes A No 3150-0010 19.Typa of aff ected public (Check as many as apply)

22. Type of activity of affected public-indicate 3-digit Standard Industrial Classification (SIC) code (s) (up to lo) - if over 1 O individuals orhouseholds 10, check O Multiple or O All 2 O state orlocalgovernments 3 O f rms eX3 businesses orotherinstitutions (exceptfarms) 8 0

i __

23. Brief description of affected public (e.g,"retailgrocerystores,"" State education agencies."" households in 50 largest SMSAs")

Physicians

24. Perpose (Check as many as appiy.11more than one. indicate

26. Collection method ;(Check as many as apply) '

pr5 dominant by an asterisk) 19 rnall self-administered *..',.. w...

1 O application for benefits

~ 2 0'oth'er self-a5 ministered '

~

2 O program evaluation 30' telephone interview

~

3 0 general purose statistics 40 personalinterview

~

4 IX regulatory or comgiliance 50.recordkeeping requirementa._

5 O program plant"ng or management

{ Required retention period;

' yea ~rs_ ;

_1 6 O research 6 0 other-describe:

25.Frequencyof Use

- 27.Co!!ection agent (Check one) 1 d' Nonrecurring 1 p requesting Department / Agency Recurring (check as many as apply) 2 O other Federat Department / Agency' 2 X) on occasion 6O semiannually 3 O private contractor '

3 0 weekly 70 annually 4 0 recordkeeping requirement.

5 0 other-describe:

4 0 monthly 80 biennially 5 0 quarterly 90 other-describe:

~

' 28. Authority for agency for information collection or

30. Do you promise confidentiality?

rulImaking-indicate statute regulation,judicialdecree.

(if yes. explain ba sis forpledge.

M.-

.-.~.e-

.10 CFR 35 M suppor#ng statement.)

W es_ p No-stc.

31.will the proposed intormation collection create a new or Atomic Enercy Act of 1954 become part of an existing Privacy Act system of records?

l 29. Rsspondent's obligation to repiy (Check as many as apply)

(11 yes. attach Federal Register notice or proposed draft of 1 ;( voluntary notice.) -

O'Yes, g[ No.

2 O required to obtain or retain benefit

32. Cost to Federal Government of 3 0 mandatory-cite statute,not CFR (attach copy of...

information collection or rulemaking s 75.00 statutory authority)

COMPLETE ITEMS 33 THRU 35 ONLY IF RULEM AKING SUBMISSION

33. Compliance costs to the public

' 34.1.= there a regulatory impact

35. ls there a statutory or judicial analysis attached?

deadline affecting issuance?

S O Yes O No O Yes. Enter date:

O No CERTIFICATION BY AUTHORIZED OFFICIALS SUBMITTING REQUEST-We certify that the d,ormation colle tion or rulemaking submitted for r :vi;w is necessary for the proper performance of the agency's functions,that the proposal represents the minimum public burde.l and Federal cost ConsistInt with need, and is consistent with applicable OMB and agency poiicy directives. Signature and title of:

i.PPRoYlNG POLICY OFFICl*L FoR AGEeder DATE susu!TTING oFFICI AL DATE Q

k}~

Daniel

.Donoghue0 b //- PJ

/

/y W R. Steo en c t

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SUPPORTING STATEMENT FOR NRC FORM 482 10 CFR 35.31 Justification Sectjon 35.31 of 10 CFR Part 35 provides for a general license for the use of iodine-125, iodine-131, cobalt-58, cobalt-60 and chromium-51 by any physician for the purpose of certain diagnostic uses. The general license sets forth the conditions pertaining to possession and use of the byproduct material.

In order for a physician to be a general licensee, NRC Form 482, " Registration Certificate - Medical Use of Byproduct Material under General License" must be e

completed and submitted to NRC,10 CFR 35.31(b). The physician must then receive a validated copy of the registration certificate with an assigned j

registration number.

Suppliers of byproduct material to other persons are required to determine that the person receiving the material is authorized to receive it. The validated registration certificate serves as evidence for the supplier that a physician is a general licensee authorized to receive the byproduct material.

f The NRC staff utilizes the information derived as a result of submission of the registration form to identify each physician using byproduct material under the general license. The certificate also contains the terms and conditions of the general license and assurb that the general licensee is aware of the terms and conditions prior to receipt of byproduct material and facilitates communication with the general licensee.

The information derived from the registration certificate is available only as a result of filing of the certificate and is not otherwise available to the Federal Government. The general license eliminates the submission of applica-tions for specific licenses.

NRC is the only Federal agency that requires the submission of registration information for the medical use of reactor-produced ir,otopes (byproduct material). NRC has closely coordinated its medical iicensing program with FDA and other government agencies to a.;sure that information requested is not duplicative.

Description of the survey plan This application requirement affects approximately 20 licensees annually.

Applicants will fill in the information requested on NRC Form 482 and submit the original and two copies to NRC.

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, Tabulation and publication plans There are no plans to publish the information received from licensees pursuant to this application requirement. The nature of the activities involved (medical use of the listed radioisotopes by physicians for diagnostic purposes) does not require the submission of proprietary informatien. The form contains a Privacy Act statemeht on page 2.

The submitted forms 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.

Time schedule for data collection ~and' publication Physicians registering for use of the general license under 10 CFR 35.31 will submit NRC Form 4P2 with the requested information. New registrations may be submitted at any time. Renewal is not required, but changes in the information submitted are required to be reported to NRC within 30 days of the effective date of such change. NRC will then issue a new NRC Form 482 using the old registration number.

Consultations outside the agency No consultations have.been held since the last clearance submittal.

Estimate of compliance burden The time required to fill out the registration certificate is estimated to be approximately 5 minutes.

20 licensees X 5 minutes = A total annual burden for all licensees of 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />.

Estimate of cost to the Federal Government The cost to the Federal Government is $75.00 which includes clerical staff (GG-7) required to assign the registration number,. file, and mail the certificates.

Enclosure:

NRC Form 482

a' U.S. NUCLEAft REGULATORY COMMISSION Approved Cy oms N*;C Form 482 3150-0022 (10-81)

REGISTRATION CERTIFICATE-MEDICAL USE OF ExNres 5 3182 10 CFR 35 BYPRODUCT MATERIAL UNDER GENERAL LICENSE Section 35.31 of 10 CFR 35 establishes a generallicense authorizing physicians to possess certain small quantities of I I 25.

1 I 131. Co 58. Co 60. and Cr 51 for specified diagnostic uses. Possession of byproduct material under 10 CFR 35.31 is not authorized until the physician has filed NRC Form 482 and received from the Commission a validated copy of NRC Form l

482 with registration number assigned.

INSTRUCTIONS Submit this Form in triplicere to: Director, Division of Fuel Cycle and Material Safety, Of fice of Noclear Meterial Safety and Sefepaards, United States Nucieer Regulatory Commission, Washington, D.C. 20555. A repistration number will be assipnad and a vot&sted copy of N#C l

Form 482 will be returned. Please print or type your name and address (inctyding ZlP codel, within and below the two dots. Limit the address to 4 lines.

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j 4

l Registration number:

paseco (if this is an initial registration, leave this space blan k - IIumber to be assigned by NRC. If this is a change ofinformation from a presiously registered generallicensee, include your registration number.!

I am a duly licensed physician authorized to dispense drugs in the practice of medicine. My license (s)is (are) valid under the laws of:

STATE (S) OF LICENSURE LICENSE NUMBER (S)

CERTIFICATE I hereby certify that:

1. Allinformation in this registration certificate is true and complete.

2. I have appropriate radiation measuring instruments to carry out the diagnostic procedures for which I will use byproduct material under the generallicense of 10 CFR 35.31 and I am competent in the use of such instruments

3. 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 Matenal Safety and Safeguards,within 30 days from the date of such change.

4. I have read and understand the provisions of Section 35.31 of NRC regulations t10 CFR 35) reprinted on the reverse side of this form;and I understand that I am required to comply with those provisions as to all byproduct materialwhich I receive. possess.use.or transfer under the generallicenw for which this Registration Certificate is filed with the Nuclear Regulatory Commission.

Date (Signature of Registrant)

WA RNING-18 U.S.C.. Section 1001; Act of June 25.1948; 62 Stat. 749; makes it a crimmal offense to make a wifffurry false statement or representation to any department or agency of the United States as to any matter ethin sts jurisdiction.

s CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR_35.31, 35.31. General 1.icense for Medical Use of Certain Quantities of (1) Name and address of the registrant; (2) A statement that the~ registrant is a duly licensed physician Byproduct Material (a) A generallicense is hereby issued to any physician to receive, authorized todispense drugsin the practice of medicine and speci-possess, transfer, or use for any of the following stated diagnostic fying the license number and the State in which such license is uses,in accordance with the provisions of paragraphs (bi,(c),and valid; and (d) of this section, the following byproduct materials ir capsules, (3) A statement that the registrant has appropriate radiation disposable syringes or other forms of prepackaged indivb.ual doses; measuring instruments to carry out the diagnostic procedures for which he p@roposes to use byproduct material unde (1) lodine 131 as sodium iodide (Nal*i for meas 4rement of licanse of 35.31 of this chapter and that he is competent in the thyroid uptake; (2) Iodine 131 as iodinated human serum albumin (IHSA) for use of such instruments.

(c) A physician who receives, possesses,or uses a pharmaceuti-determinations of blood and blood plasma volume; e

(3) Iodine 125 as lodinated human serum albumin (IHSA) for ca! containing byproduct material pursuant to the generallicense determinations of blood and blood plasma volume; estabbshed by paragraph (a) of this sectiori shall comply with,the (4) Cobalt 58 for the measurement ofintestinalabsorption of following:

(1) He shall not possess at atty one time, pursuant to the gen-cyanocobalamin; (5) Cobalt 60 for the measurement ofintestinal absorption of eral license in paragraph (a) of this section, more than:

cyanocubalamin; (i) 200 microcuries of iodine 131 (6) Chromium 51 as sodium radiochromate for determination

• (ii) 200 microcuries of iodine 125, of red blood cell volumes and studies of red blood cell survival time.

(iii) 5 microcuries of cobalt 58, Note: Section 32.70 of this chapter requires manufacturers of (iv) 5 microcuries of cobalt 60, and radiopharmaceuticals which are under the general license in this (v) 200 microcuries of chromium S t.

paragraph to include the fouowing statement in the label affixed to (2) He shall store the pharmaceuticaluntiladministered i, the n

the container or in the leaflet or brochure which accompanies the original shipping container or a container providing equivalent radi-radiopharmaceutical:

ation protection; (3) He shalluse the pharmaceuticalonly for the uses authorized This radioactive drug may be received, possessed, and used only by paragraph (a) of this section; by physicianslicensed to dispense drugs in the practice of medicine.

(4) He sL1 not administer the pharmaceutical to a woman its receipt, possession, use, and transfer are subject to the regula-with confirmed pregnancy or to a person under 18 years of age; tions and a generallicense of the United States Nuclear Regulatory (5) He shall not transfer the byprodue: 'naterial to a person Ceau.ussion or of a State with which the Commission has entered who is not authorized to receive it pursuant to a license issued by into an agreement for the exercise of regulatory authority.

the Commission or an Agreement State, or in any manner other than in the unopened, labeled shipping container as received from the suppber,except by admmistertng it to a patient.

(Name of manufacturer)

(d) The registrant possessing or using byproduct material under (b) No physician shall receive, possess, use, or transfer byprod-the general license of paragraph (a) shall report in duplicate to the uct material pursuant to the general license e tablished by para-Director of Nuclear Materia! 5afety and Safeguards,any changes in graph (a) of this section until he has filed NRC Form 482,"Regis-the information furnished by him in the " Registration Certificate-tration Certificate-Medical Use of Byproduct Material Under Medical Use of Byproduct Material Under General License " NRC General License" with the Director of Nuclear Matefial Safety and Form 482. The report shall be submitted within 30 days after the Safeguards, U.S. Nuclear Regulatory Commission Washington, effective date of such change.8 D.C. 20555 and received from the Commission a validated copy (e) Any person using byproduct material pursuant to the gen-of the NRC Form 482 with registration number assigned. The eral license of paragraph (a) of this section is exempt from the registrant shall furnish on NRC Form 482 the following informa.

requhements of Parts 19 and 20 of this chapter with respect to tion and such other information as may be required by that form:

the byproduct materials covered by the generallicense.

NOTES A new triplica;e set of this Registration Certificate, NRC Form 482, may be used to report any change in information furnished by a 3

35.31(d).

rrgistrant as required by If larger quantities or other forms of byproduct material than those specified in the genera! license of 30 CFR 35.31 are required, the physician should 'ile an " Application by Byproduct Material License, Medical," NRC Form 313M and obtain a specific byproduct material l

license. Copies of applic- %n and reg;stration forms may be obtained from the United States Nuclear Regulatory Commission. Washington, l

D.C.,20555, Division of k

• Cycle and Material Safety.

PRIVACY ACT STATEMENT Pursuant to 5 U.S.C. 522a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the following statement la furnished to individuals who suppiy information to the Nuclear Regulatory Conimission on NRC Form 482. This information is maintained in a system of records designated as WRC 3 and described at 40 Federal Register 4 5334 (October I,1975).

n

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

2. PRINCIPAL PURPOSE (S) The information is evaluated by the NRC staff pursuant to criteria set forth in 10 CFR Parts 30 36 to deter.

mine whether the applic' 7 forms to the requirements of the Atomic Energy Act of 1954, a amended, and the regulations of the NRC, for the issuance of

,n certificate authorizir's the.use of byproduct material for medic use.

I

3. ROUTINE USES The information may be used: (s) to provide records to State health depar*ments for their information and use; and (b) te proyide information to Federal, State, and local health officialJ and other persons in the event ofincident or exposure for purposes of their information, investigation, and protection of the public health and safety. The information may also be disclosed to appropriate Federal, State, or local agencies in the event the information indicates a violation or potential violation oflaw and in the course of an administrative or judicial proceeding. In addition, this information rnay be transferred to an appropriate Federal, State, or local agency I

to the extent relevant and necessary for an NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL. OF NOT PROVIDING INFORMA.

TION It is voluntary that you furnish the requested information. lf the requeste4 information is not furnished, however, the registration certificate or amendment thereof,will not be processed.

5. SYSTEM MAN AGER(S) AND ADDRESS:

Director, Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards U.S.Nuclesa Regulatory Comrhissiop Washington, D.C. 20555

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