ML19325D103

Request for OMB Review & Supporting Statement Re 10CFR35, Medical Use of Byproduct Matl. Estimated Respondent Burden Is 18,788 H

ML19325D103
Person / Time
Issue date:	10/10/1989
From:	Amenta J NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML19325D102	List: ML19325D101 ML19325D103
References
NUDOCS 8910190010
Download: ML19325D103 (22)

Text

E.

i y;4..

p%dagss" Request for 0MB Reviel (Rev september 1983)

Important .

Send three copies of this form, the material to be reviewed, and for

., Read instructions before completing form. Do not use the same SF 83 '

1 to request both an Executive Order 12291 review and approvat under paperwork-three copies of the supporting statement, to;

%g i the Paperwork Reduction Act-f

. ' Answer all questions in Part 1. If this request is for review under E.0c Office of Information and Regulatory Affairs '

12291,- complete Part 11 ant' sign the reguiatory certification

If this Office of Management and Budgeto '

O.g ~ request is for appro.al under the Paperwork Peduction Act and 5 CFR Attention: Docket Ubrary, Room 3201 1320. skip Part II, complete Part 11! and sign the paperwork certification.

Y!ashington, DC 20503.

-i h;.

i : PART l.-Complete This Part for Ali Requests.

~

L. Dep rtment/ agency and sureau/ office cTinatmg request

2. Agency code,

t L U. S. Nuclear Regulatory Commission -

3 1-S' 0 l

3. N me of person who can best answer questions regaroing this request

. Telephone nurnber.

James H. Myers (301 )492-0637

' 4. Title of snformation coilection or ruten.aiong 10 CFR Part 35

. Medical Use of Byproduct Material

5. Legal authonty for snformatson conection or rule (cste United States Code, Puohc law. or becutwe Order)

'42 use ; 2201(o)'

' 6.~ Affected public (c'>eck a.'i f5Jf afpi))'

$ @ Federalagenciesoremployees 4 O indmou' is or housenoios-3 0 raims e 2 Non orofit institutions a

2' 3 Stateorlocaigovernments 4 3 Businesses or other for profit 7 @ Smallbusinessesororgancations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291

7. Regu!ation Identif.et N Jmber (RIN).

7 - _ _

_. or. None assigned O '

CType of submission (check one on each category)

Type of reviewrequested Classification Stage of development 10 Standard l' ~ O Maior =

i O rroposed or eraft 2 O eendmg

12. O No'nmajor 2 O rinaior enterimfinai.witnpnorproposai 3 O ' emergency

' 3 0 rinaimntenm finai, without pnor proposai 4 O statutoryoriudiciaideadhne

- 9. CFR secten affected CFR

'10. Do:s this regutation contain repcrting or recordkeeping requirements that recuire OMB approval under the Paperwork Reduction Act

. O Yes : O No

- and 5 CF91320?

,(.

2 0.ves 2 O no

11. If a major rule. Is there a regulatory impact analysis attached?

3 0 ves 4 O No If"No," did OMB waive the analysis?

C rtification for Regulatory Submissions

! In submitting this request for OMB review, the authonzed regulatory contact and the program official certify that the rec Jirements of E.O 12291 and any apphcable -

l pohcy directives h.Jve been comphed with.

I Date Signature of program official -

L S'gnature nf autnorged regulatory Contact Date

12. (OhtB use only)

~

standard forma 3(Rev 9 83)

Previen e+t.m onwete g3 gg Prestnoed by OMB

.NSN 754o Oo rd4 dup 5 CFR 132o and [ O 12231 8910190010 891005 P Dr<

ORG EUSOMB PDC E

I py.

L F.PART ill.-Complete This Part Only if the Request is f:r Apprivalef a C:llectlin

[

' of information Under the Paper ~rk Reducti'n Act rnd 5 CFR 1320.

Ic 3g Absgation Safety, Radioact ye Materials, Nuclear Medicine" et-Describe needs. uses and affecte ublic iri 50 waros or less =

Ra 10;CFR'Part 35 contains-requirements-that apply to NRC licensees who are authorized' to administer.

e byproduct material or its radiation to humans for medical care.

The information in the required-

, reports-and records is used by.the NRC to make licensing and regulatory decisions to ensure s

protection of the public' health' arld_ Safe.ty-( "14. Type of inforrr ation collection (checA only one) j;

~ frsformation collections not containedin rules

< 51 O Reguiar submission 2 O tmergency submission (cert,ficationattached) w information collections conf alnedin tules

3 0 Existmg regulation (nochangeproposed) 6 Final or intenm fmal.rithout pnor NPRM

7. Enter date of expected or actual Federal

. 4 O Notice of proposed rulemakmg(fiPRM)

A O Regular subrmssion Register pudicatiot; at this stage of rulemakmg

' 5 0 rinal, NPRM was previously'oubbshed e O cmergency submission (cerr<r. cat:en attached)

(month.dar rear >

1

35. Type cf review requested (checA only one)

- 1 O New collection 4 O Re.nstatement or a prev ousiy approved eciiection for which approvai 2 O revis,on of a currentir approved coiiection

"*5'

3 0 Extension of the empiration date of a currently approved collectcon 5 0 taist.ne coiteciton in use without an ous controi number

- wtthout ar,y change in the substance cr m the method of coilection

16. Agency teport form numtur(s)(metude stancard/ optional form number (s))

22. Purpose of informatson collection tcheck as many as apply) l

'Not applicable 1 O Apphcitionior tenefits q

2 O engram evaivation j

17. Annual reporting or d;sclosure burden 3 O Generalpurposestatistics 1 Number of respondents.

2a400 4 L n,gui,to,y o, compn.,.ce 3 509.6 5 O Pr.agram planr.ing or management 2 Number of responses per respondent 1

Y 422 955 s a n,se,ren 3 Total annual responses (hre 1 times 1.ne 2) a

~.002 7 O Asdit

' 4 Hours per response 5 Total hours th"e 3 times one a) 18 7N I

. 18. Annuit recr**okeepmg burden

23. F requency of "cordkeeping o' reporting (cf.eck all that apply) -

2,400 10 Recordkeepmg 1 Number of recordkeepers.

iib *4 Report /ns 2 Annual hours per recordkeeper.

3 total recordkeeping hours (hne 1 times hne 2),..

284,156 2 f0 onoccasion

. 4 Recorekeepmg.ctentionperiod. 3. years to duration years 3 0 w-iy

19. Total annual burden of license 4 O Monthiy 302,944 5 0 quarte,,,

1 Riquested(Ane 17 5 plus hne 18 3).

419.929 6 0 semi-annuaiiy

-l

2 in.:urrent OMB nventory 116.985 7 O Annuany i

F 3 Dinerence (Sne 2 /ess hne 2)

Explanation of diffe"rence e O B,ennialsi 4 Program change 9Cl otner(desence):.Renewah every c; ynr3 l

116.985 j

5 Adiustment.

' 20. Current (most recent) oMB control number er comment number

24. Respondents' obl gatton to comply (check the strongest obbgation thatapp a s) l 3150-0010

- 1 0 voruntary

21. Requested expiration date 2

Required to obtain or retam a benefit

'3 years from approval date 3XI Mandatory

25. Are the respondents pnmarify educational agencies or inst:tutions or is the pnmary purpose of the collection related to Federal education programs' O ves 0 No

26. Does the agency use samphng to select respondents or does the agency recommend or prescribe the use of sarnpling or statistical analysis

. O ves 0 No by responcentsi U

' 27. R:gui ry authonty for the information collection

~

Part 35

o, FR

or,other tspecity):

CFR Paperwork Certification In samittmg this request for oMB approval, the agency head. the senior official or ar authorized repruentative, certifies that the requirements of 5 CFR 1320. the

' Pnvacy /.ct statistical. standards or directives, and any other applicable information pohcy directives have been comphed with.

5 gr.ature of prograra of t.cial Date Date S netvre of agenky head. the senior lfficial or an authorized representative Aloyc2 A. ' menta, Sis gnated Sen or Officia i

i

( for Jnformation Resources Management g

g gg i98.i o - 453 6

]I o cro n

7, r,., 3 e.-

+

r; 7.;

e.:

t; w

SUPPORTING STATEMENT-1 FOR' 10 CFR PART.35

-c 3

MEDICAL'USE OF BYPRODUCT MATERIAL AND i

NRC FORM 473

^

DIAGNOSTIC MISADMINISTRATION REPORT l Bac_kground 10 CFR Part 35, Medical Use of Byproduct Haterial, contains requirements that-I applyLto Nuclear Regulatory Congnission (NRC) licensees who are authorized to.

~ dminister. byproduct material.or its radiation to humans for medical diagnosis

[

a and therapy. NRC Form 473 is used by NRC medical licensees to report s

diagnostic misadministrations of radiopharmaceuticals as required by 10 CFR i

Section 35.33.

b Justification

'Part of NRC's function is to license and regulate the use of byproduct

= materials in order to assure protection of the public. health and safety. The

NRC requires licensees to perfernrcertain tasks to ensure fulfillment of their

~

obligations. The records required in this part are the least burdensome way for licensees to demonstrate compliance. Occasionally, safety ratters are of i

such' significance that others need to be aware of information in order to perform their jobs or work.in a safe manner.

In these cases, reports are

~

required.

Need for and Practical Utility of the Information Collection

?

. Sections 35.12 (b) and (c) of 10 CFR Part 35 require that applicants submit a completed NRC Form 313. The form elicits an orderly description of the appli-cant's complete radiation safety program.

Requests for amendments and license renewals may be submitted in letter format.

This report is needed to assure m

m

d

. j 1

f.

' NRC that the applicant'has programs in place adequate to protect health and miniraize danger to' life and property before NRC can authorize receipt of radioactive material. NRC: Form 313 has previously been cleared under CMB No.

3150-0120, which should be referred to for additional supporting information, as well as burden and cost data.

Section 35.13'of_10 CFR Part 35 requires that licensees apply for and receive a license amendment before using material not allowed by the license, before adcing to or changing key individuals, before receiving more material than allowed by the license, or before changing the_ location of use or mailing address. The triggering events n e critical ir.dicators of a potential for change in the licensee's ability to control radation dose vorkers and the public, or the NRC's ability to contact the licensee or con %

in inspection of the licensee's program. The information is_needed so that tne staff can determine whether the licensee has individuals with adequate training and experience to safely use radioactive material and the facilities and equipment

. needed to assure protection cf public health and safety.

Section 35.34 of 10 CFR Part 35 requires that licensees riotify the NRC within 30 days if a key worker ends his association with the licensee. This prompt report is needed because if the licensee no longer has a complete staff, the collective training and experiehce of the rernaining staff may no longer be sufficient to cnsure safety. This repcrt will trigger a check of the licensee's file to determine whether the licensee's remaining users are qualified to receive and use material safely.

Section 35.20 requires licensees to have a written program to keep radiation I

dose as low as reasonably achievable. The program must be written to provide clear staternents of authority, responsibility, and technical requirements.

Section35.21(b)(2)of10CFRPart35requiresthatthelicenseeestablishand impicn.ent the written policy ana procedures that were submitted as part of the application. The policy anc prccedures are needed so that the staff can review them and make a determination that the applicant can meet the requirernents of the Atomic Energy Act and the Commission's regulations. The procedures must be iniplemented in order to provide for protection cf the public health and safety.

2

g h:'

,; 'i 9

~.

g

~

The burden is included in the burden for the application, NRC Form 313, OMB No.

3150-0120.

Sections 35.22(a)(4) and (5) of 10 CFR Part 35 require that medical institution licensees retain a copy of Radiation Safety Committee meeting minutes for the duration of the license, and prescribe the information required in the minutes.

This' record is needed to show continuing management oversight of the radiation safety pngram.

Section 35.23(b) of 10 CFR Part 35 requires that licensees provide 5 written statement of authority, duties, responsibilities, and-radiation safety activi-ties for the Radiation Safety Officer and Radiation Safety Corrinittee.

The statement is needed so that managers and key users know their responsibilities.-

The statement must be retained for the duration of the license.

1

'Section 35.27(a) of 10 CFR Ptrt 35 requires that licensees provide written per-mission to visiting authorized users to work under the licer.se. Section 35.27(c) requires licensees to retain a copy of an NRC or Agreement State license-identifying the visitor as an authorized user.

This permission and record are needed to show that licensee management has permitted thic work, and that a regulatory agency has reviewed and approved the visitor's training and

-j experience.

Section 35.29(b) of 10 CFR Part 35 requires' that motile nuclear medicint ser-

-vice licensees keep a letter of permission signed by the management of each client. This record is needed to show that client management has permitted this work.

Section 35.31(b) of 10 CFR Part 35 requires that licensees make a record of minor radiation safety program changes. This record is needed to show what raaiation safety factors were considered before implementing the change, and also provides a record of where within the licensee's facility radioactive l

materials were received, used, and stored.

Section 35.33(a) of 10 CFR Part 35 requires that the licensee notify by tele-phone the appropriate NRC regional office in case of a therapy 3

L

=;

i misadministration within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovering the misadministration.

This prompt notification is necessary because a therapy misadministration spay present o' clear and present radiation hazard to members of the public that might be mitigated by NRC assistance. The licensee is also required to notify

'the referring physician and the patient or a responsible ' relative (or guardian) i of the patient unless contraindicated by factors known to the referring physician. These reports are needed so that adequate care can be provided for the patient.-

Section 35.33(b) of 10 CFR Part 35 requires that a licensee file a written report to NRC within 15 days after telephoning an initial therapy misadmini-stration report. This report is needed so that NRC can determine whether-there i

might be generic in.plications in the incident which would require notification j

of all licensees. The licensee is allowed 15 days to submit the report so that it can review and analyze the event and provice NRC with a complete history of the event. NRC requires submission of the report within 15 days se that it can promptly notify other licensees of a generic problem.

l-Section 35.33(c) of 10 CFR Part 35 requires that the Radiation Safety Officer investigate the ~cause of diagnostic misadministraticns and make 'a record for NRC review. The licensee cust also notify the referring physicicn and the NRC Regional Office in writing on NRC Form 473 within 15 days. These written records are needed to determine what kinds of errors precipitate diagnostic misadministrations, and also provide an indicator of the' licensee's management

control of the radiation safety program.

Section 35.33(d) of 10 CFR Part 35 requires licensees to retain a record of L

each misadministration for 10 years. Misadministration events occur infrequently, and recoras must be retained for a sufficiently long time to evaluate the effectiveness of the licensee's corrective actions.

.Section 35.50(b)(4) of 10 CFR Part 35 requires that licensees make a recora of a geometry dependence test for the dose calibrator. This record is needed to demonstrate the relationship between volume configurations of the radio-pharuaceutical and the accuracy of the reading given by the dose calibrator.

4

y 5

.,u

? :..

p Section 35.50(e) of.10 CFR Part 35 requires that licensees retain'a record of

. checks and tests of dose calibrator performance. This record _is needed to show 1

-that the dose calibrator is functioning correctly and is capable of accurately masuring radiopharmaceutical-dosages.

\\

. Sectico 35.51(a)(3) requires that the licensee note on a survey instrument the apparent exposure tate from a ocdicated check source at' the time of instrument

-calibration.

This information is needed so the licensee can check the survey.

instruma.t f or proper operation-before sceking measurements. The burden is included in the burden estiiste for Section 35.51(d).

Secticr: 35.51(d) of 10 CFR Part 35 requires that licensees retain a record'of c

survey instrument calibrations. This record is needed to show that survey instruments were calibrated and cperational.

{

.Section 35.53(c) of 10 CFR Part 35 requires that licensees retain a record of each radiopharmaceutical dosage measuren.cnt. This record is needed to show that licensees are mainteihing control of the use cf radiopharmaceuticals.

Section 35.59(a) of 10 CFR Part 35 requires that licensces maintain written instructions for the safe use of sealed sources and brachytherapy sources.

These instructions are needed so that inaividuals who are handling sources can determine the specific safety measures appropriate for each kind of-source b

used.

Section 35.59(d) of 10 CFR Part 35 requires that licensees retain a record of sealed source leak tests. This recora is needed to show that the leak test was done at the appropriate time, and that the test showed that the source was not leaking.

Section35.59(c)(2)requiresthatlicenseesfileareportwiththeNRCwithin five days if leakage of a sealed source is detected.

This report is needed so that NRC can make a determination as to whether other licensees who have similar scaled sources should take special precautions, hRC allow:; the licensee 5 days to submit the report so that it can review and analyze the source and the leakage rceasurement. NRC requires submission of the report 5

g 9

w

-weo ni-,

a ww-

,1 a

a 3

i within 5 days so that it can promptly notify other licensees if it appears i

. there may.be a generic problem.

Section 35.59(g) of 10 CFR Part 35 requires that licensees make a record of sealed'so"rce and brachytherapy source _ inventory. This inventory is needed to show:thr < ssession of sealed sources did not exceed the amount authorized by

. the license. The five-year recordkeeping requirement will help to assure con-tinued control over these sources thht are only occasionally _ used.

Section 35.59(1) of 10 CFR Part 35 requires that licensees take a record of radiation surveys of areas where scaled sources and brachytherapy sources are stored. This record is needed to show that acequate radiation shielding has been provided for such scurces, and that dose rates in contiguous areas are within allowed levels.

Section 35.60(b) of 10 CFR Part 35 requires that licensees label each syringe a

or syringe. radiation shield as to its centents. This label is needed because L

review of misadministration reports has indicated that in many cases misadmin-istrations are caused by inadvertent transposition of syringes.

Section 35.61(b) of 10 CFR Part 35 requires that licensees label vial radiation shields with the identity of the radiopharmaceutical contained. NRC review of several nisadministration reports indicates that many misadministrations occur when-technicians draw a dosage.from the wrong vial of radioactive material.

~ Labels will help to reduce the chance of this happening.

L Sections 35.70(d) and (g) of 10 CFR Part 35 require that the licensee establish action levels for radiation surveys. The action levels provide the individual who makes a radiation survey with information on what levels are expected and what levels require investigation. The sections also require that the licensee i

inciediately notify the Radiation Safety Officer if excessive ievels are e

detected during a survey. This report is needed so that the Radiation Safety Officer can take appropriate remedial action. The Radiation Safety officer is the one individual onsite who is qualified to determine what action is needed to ensure worker anc public health and safety, and whether that action is needed insnediately or can be delayed.

6 m

~.

s Section 35.70(h) of 10' CFR Part 35 requires that' licensees retain a record of-radiation surveys. -The record is needed to show that the required surveys were made.

Section 35.80(f) of 10 CFR P. art 35 requires that mobile nuclear medicine service licensees make a record 'of radiation surveys. The record-is needed to i

. show that the required surveys were u.aoe.

l Section 35.92(b) of 10 CFR Part 35 requires that licensees make a record of disposal of waste that was decayed in storage. The record is not.oed to show that materiait were decayed for the proper length of time and that a proper -

survey of each waste container was made prior to disposal.

Section 35.204(c) of 10 CFR Part 35 requires that licensees retain'a record of.

molybdenum-99 concentration in radiopharmaceuticals. This record is needed to show that the ccncentration measureant was made and that the n.aximum molybdenum-99 concentration level was not exceeded.

L Secticn35.205(d)-requiresthatthelicenseepostatimeperiodofevacuation l-in _ areas where aerosols and gases are used.

In case of a spill, this prov' ides

' notice to workers of how much time air handling equipment needs to reduce -the y

air concentration to permissible limits. The licensee must retain a record of I

the calculations used to determine the evacuation time for the duration'of the licc r,se.

l Section 35.310(b) of 10 CFR Part 35 requires that licerisees retain a record of radiation safety instruction given to personnel who care for radiopharree-ceutical therapy patients. This record is needed to shcw that the training was given.

Sections 35.315(a)(2) and 35.415(a)(2) require that the licensee post radiopharmaceutict.1 therapy and brachytherapy patient room doors with a

" Radioactive Materials" sign. This provides notice to hospital workers and the public that there is radioactivity in the room. The section also requires that the licensee note in the patient's chart how long visitors may stay in the 7

+

1 a w.'

E patient's room. This is the most convenient way to provide this information to.

nurses, who are usually responsible for enforcing visiting rules.

Sections 35.315(a)(4) and 35.415(a)(4) require that licensees make a record of dose rates around radiopharmaceutical treatment and implant treatment rooms.

.t This record is needed to show that members of the public are not exposed to excessive levels of radiation.

Section 35.315(a)(8) of 10 CFR Part 35 requires that licensees make a record of the thyroid burden measurement of each individual who helped prepare or admin-ister a therapeutic dosage of iodine-131. This record is needed to show that workers were not exposed to excessive levels of iodine-131.

Sections 35.'315(b) and 35.415(b) of 10'CFR Part 35 require that-the licensee-promptly notify the Radiation Safety Officer if the radiopharmaceutical therapy-or brachytherapy patient dies or has a medical emergency.

This report is needed so that the Radiation Safety Officer can take whatever actions are necessary-to prevent a spread of radioactive contamination or loss of brachytherapy sources.

Tne Radiation Safety Officer is the one individual onsite who is qualified to determine what action is needed to ensure worker and public health and safety, and whether that action is needed immediately or can be delayed.

Section 35.404(b) of 10 CFR Part 35 requires that licensees retain a record of the radiation survey of-each patient who was treated with temporary implant sources. The record is needed to show that the survey was made.

't i

l,

' Section 35.406(b) of 10 CFR Part 35 requires that licensees make a record of brachytherapy source use. This record is needed so-that, if a brachytherapy source is misplaced, the licensee knows where to look for it.

Section 35.406(c) of 10 CFR Part 35 requires that licensees make a record of radiation surveys of patients after implanting sources. This record is needed to'show that the survey was made.

I Section 35.406(d) requires that the licensee retain a record of the use of bractytherapy sources and special safety surveys. This record is needed to 8

J' J,

.n show that-the licensee is providing adequate control for these sources.

The record. burden is< included in'the burden estin. ate for Sections 35.406(b) and I

i*'

(c).-

t Section 35.410(a) of 10 CFR Part 35 requires that licensees provide written radiation safety instruction for personnel caring for implant therapy patients.

This instruction is needed so that these personnel may stu@ and refer to it while caring for the patient.

Section 35.410(b) of 10 CFR Part 35 requires that licensees retain a record of training for personnel who care for implant patients. This record is needed te show that the training was given.

Section 35.606.of 10 CFR Part 35 requires that licensees apply for and receive L

~ a-license amendment before naking certain changes in the teletherapy program.

This-license amendu.ent process is necessary because the licensee might consider making changes that would cause radiation levels in restricted and unrestricted areas to exceed permissible levels.

a l-Section 35.610(a) of 10 CFR Part 35 requires that iicensees post written l

instructions for indiviouals who operate teletherapy units. These instructions L.

are needed to remind workers of proper operating procedures.

Section 35.610(c) of.10 CFR Part 35 requires that licensees make a record of l

training for individuals who operate teletherapy units. This record is needed l-to show that the training was given.

Section 35.615(d)(4) of 10 CFR Part 35 requires that licensees retain a record of the teletherapy room radiation nenitoring device function check. This

. record is.needed to show that the check was niade.

.Section 35.630(c) of 10 CFR Part 35 requires that licensees retain a record of each calibration, intercomparison, and comparison of teletherapy dosimetry equipment. These records are needed to show that measurements of radiation teletherapy doses were niade with instruments capable of making accurate measurenent::.

9

O Section 35.632(g) of 10 CFR Part 35 requires that licensees retain a record of

'6 teletherapy unit calibration. This record is needed to show that the calibra-

+>

tions were done id that licensees did not ir,cdvertently oominister incorrect radiction doses to patients.

Section 35.634(c) of 10 CFR Part 35 requires that the qualified teletherapy calibration expert report the results of teletherapy unit spot-checks pror$tly to the licensee. This assures the licensee that the results of each spot-check have been reviewed by an expert. The litersee must keep a copy of roch report to assure that the review has been made.

Section 35.034(f) of 10 CFR Part 35 requires that licensees rett.fn a reccrd of spot-checks. This record is needed to show that the required checks ucre inade.

Section 35.63C(c) of 10 CFR brt 35 requires that licensees retain a record of safety checks for teletherapy facilities. This record is needed to show that the checks were made.

Secticn 35.641(c) of 10 CFR Part 35 requires that licensees retain a record of radiation incasurerents af ter inst 6111ng a source in a teletherapy unit. These records provide assurance that the source-is properly installed within the teletherapy unit, and that dose rates outside the teletherapy room are within y

permissible limits.

Section35.643(a)(3)of10CFRPart35requiresthatlicenseesamendareport made to NRC pursuant to Section 35.645 to include additicnal survey informaticn if changes in an installation as approved by NRC were necessary. The additional inforuation in the report provides assurance to IRC that dose rates in restricted and unrestricted areas are within permissible limits. The 30-day submission requirement is cont ned in Section 35.645.

l5 Section35.643(b)of.10CFRPart35requiresthatlicenseesrequesta11ctr.se anendment if radi6 tion icvels in unrestricted areas are above permittec levels.

This report will trigger an indepth NRC review of safety consideraticos before it allcws a licensee to operate the unit. The 30-day submission requirement is containea in Section 35.645.

10

l 1

Sectica 35.645 of 10 CFR Part 35 requires tht licensees mail a copy of tele-therapy source installation records to the NRC.

This record is needed to show that dose rates in restricted and unrestricted areas are within permissible levels. The submission must be made within 30 days after the completion of the action that initiated the record requirement. The 30-day requi-ement is imposed because of the especially high dose rates that can be found around teletherapy units.

Section 35.647(c) of 10 CFR Part 35 requires that licensees keep a record of teletherapy unit inspection and servicing. This record is needed to show that the required work was done.

Reduction of Burden Through Information Technolog There are no legal obstacles to reducing the burden associated with this information collection. However, because of the types of information and the infrequency of submission, the applications and reports do not lend themselves readily to the use of automated infortnation technology for submission.

l i

I Effort to Identify Duplication The Information Requirements Control Automated System (IRCAS) was searched to I

determine duplication. None was found.

In general, information required by NRC in applications, reports, or riccrds concerning the transfer, receipt, possession, or use of byproduct material does not dupli. ate other federal infornetion collection requirements and is not available from any source cther than applicants or licensees. Portions of the needed information might also be contained in other information submittals to WRC or other federal agencies.

However, duplication, if any, is slight, and the collection of this information by use of specified forms and other required reports and records is the most l

effective and least burdensome means of obtaining the information.

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

Effort to Reduce Small Business Buroen The majority of licensees who use byproduct material are small businesses.

Since the health and safety consequences of improper handling or use of 21 pg.,

,,,+.

3 p

p--

y w.

r.-y.

p m--

a

E

~

~

l i

radioactive byproduct raterial are the same for large and small entities, it is not possible to reduce the burden on small businesses by less frequent or less complete reporting, recordkeeping, or accounting and control procedures.

Consequences of Less Frequent Collection j

Required reports are collected and evaluated on a continutng basis as events occur. Applications for Aw licenses and amendunts are submitted only once.

Applications for renewal of licenses are submitted every five years.

Infonnaticn submitted in previous applications may be referenced without being i

resubmitted. The schedule for collecting the information is the minimum frequency racessary to assure that licensecs will continue to conduct programs in a manner that will assure adequate protection of_ the public health and

{

safety.

Circumstanus Which Justify Variation f rom OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 35.14 requires that

+

licensees notify the NRC within 30 days if a key worker ends his association with the licensee. This prompt report is needed because if the licensee no longer has a cor.plete staff, the collective training and experience of ti.e i

remaining staf f n.sy no longer be sufficient to ensure safety. This report will l

trigger a check of the licensce's file te determine whether the remaining key u:.ers are c,ualified to receive and use material safely.

Section 35.33(a) requires that the licensee notify by telephone the appropriate NRC regional of fice in cese of a therapy misaoministration within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> iifter discovering the misadministration. This prompt notification is necessary because a therapy misadministration may present a clear and present radiation hazord to a nuber of the public that r.ight be mitigated by NRC assistance.

The licensee is also required te rotify the referring physician and the patient or a responsible relative (or guardian) cf the patient unles contraindicated by f actors known to the referring physician.. These reports are aceded so that adcquate care may be provided for the patient.

Section 35.33(b) requires that a licensee file a written report to NRC within 15 days after telephoning an initial therapy misaaministration report. This report is needed so that NRC can determine whether there might be generic 12

i implications in the incident which indicate a need to notify all licensees.

l NRC allows the licensea 15 deys to submit the report so that it can review and I

analyze what has happened and provide NRC with a cot.plete history of the event.

I NRC requires submission of the report within 15 days so that it cari promptly notify other licensees if it appears the precipitating event might be generic.

Section 35.33(c) requires that the Radiation Safety Officer investigate the cause of diagnostic misaaministrations and raake a record for NRC review. The liccnsee must also notify the referring physiciar ar.d the NRC Regional Office j

in writing on NRC Form 473 within 15 cays. These written rew rds are needed to

^

determine what kinds of actions precipitate misedministrations, and also provide an indicator of the licensee's unagement control of thc radiation safety program.

Section35.59(e)(2)requiresthatlicenseesfileareportwiththeNRCwithin five days if leakage of a sealed source is detected. This report is needed so that NRC can raoke a detertaination as to whether other licensees who have similar sealed sources should take special precautions. NRC allows the

+

licensee 5 days to submit the report so that it can review and analyze the source and the leakage measurement. 11RC requires submission of the report within 5 days so that it can promptly r.otify other licensees if it appears there may be a generic problem.

Section 35.645 requires that licensees mail a copy of teletherapy source installation records to the NRC.

This record is needed to show that dose ratcs in restricted and unrestricted areas are within permissible levels. The submission raust be inade within 30 06ys efter the completion of the action that initiated the record requireraent. The 30-day requirement is imposed because of the especially high dose retes that can be found around teletherapy units.

Consu_1,tations Outside the,AJeracy Several experts in the use of radioactive meterial for patient care were asked to comment on the technical content, including the informaticn collection requirements, of the proposed regulation. They were representatives of:

Food and Drug Aorainistration, Araerican Association of Physicists in Medicine, Health Physics Society, Society of Nuclear 14edicine, and the American College of 13

3

_=

y J

';li

).

i

.. g

O 1

4 P.6diology. The concents received were considered in promulgating the {inal rule. There have been no consultatiens outside the agency since the promul-

.gation of the-revised rule.

4 Confidentiality None, except for proprietary information.

i i

f' Sensitive Questions None.

E Number and Type of Respondents These requirements will affect approximately 2400 licencces and applicants, f

. About 2200 of the licensees are hospitals, and about 200 of the licensees are physicians in private practice.

3 1

i s

l l=

l f

i 14

(;..,.

I Estimate of Compliance Burden Reporting Requirements j

Licenste Total Annual No. of Licensee Staff Hours Licensee Burden i

Section Responses Annually Per Submittal (Hours) 35.12(b)

See OMB Clearance No. 3150-0120 l

35.12(c)

See OMB Clearance No. 3150-0120 35.13 1300 3

3900 35.14 200 0.5 100 35.27(a)(1) 300 0.5 150 35.27(a)(2) 300 0.5 150 35.33(a) 5 1

5 35.33(b) 5 10 50 35.33(c)

See NRC Form 473 (below), OMB Clearance No. 3150-0140 35.59(e) 1 2

2 6

35.60(b) 7.0x10 5.55y10~4 3885 6

35.61(b) 1.4x10 4.16x10-3 5824 30.70(d) 2400 0.02 48 35./0(g) 2400 0.02 48 l

35.315(b) 1 1

1 k

35.315(a)(2) 8400 0.2 1680 35.410(a) 600 1

600 l

35.415(a)(2) 4000 0.2 800 35.415(b) 1 1

1 l

35.606 40 1

40 35.610(a) 80 0.5 40 35.634(c) 2890 0.5 1445 35.643(a) 1 2

2 35.643(b) 1 2

2 35.645 30 0.5 15 Total 8,422,955 18,788 l

NRC Form 473 300 0.5 150 15

t

.~;

I ei Recordkeeping Requirements Total No. of Record-i Reerd--

Annual Hours keeping Record Section ke epers per Recordkeeper Hours Detention Period j

35.20 see35.12(b)and license duration (c)*

35.21(b)(2) see35.12(b)and license duration (c)*

35.22(a)(4) ano(a)($)

2200 4

8800 license duration 35.23(b).

sec 35.12(b) and license duration (c)*

35.27(c)-

see35.27(a)*

3 years after last use 35.29(b) 50 1

50 3 years af ter last service.

35.31(b) 1200 1

1200 license renewal or termination 35.33(c) 300 2

000 10 years

i 35.33(d) see 35.33 (b) and 10 years (c)*

35.50(b)(4) see35.50(e)(4) eqpt. duration 35.50(e)(1) 2400 0.03 72 3 years 35.50(e)(2) 2400 0.2 480 3 years 35.50(e)(3) 2400 2

4P00 3 years 35.50(e)(4) 380 1

380 eqpt duration t

35.51(d) 2400 0.4 960 3 years and(a)(3) 35.53(c) 2400 8.3 20000 3 years 35.59(a) 2400 0.5 1200 eqpt. curation 35.59(d) 2400 2

4800 3 years 35.59(g) 2400 4

9600 5 years

)

35.59(1) 2400 0.2 480 3 years 35.70(h) 2400 80 192000 3 years 35.80(f) 20 80 1600 3 years 16

y -

7 v

.c A.',.,

f RecordkeepingReg'u'irements(Continued)

Total No. of Record-i Record-Annual Hours keeping Recced i

Section keepers per Recordkeeper Hours Detention Period 35.92(b) 2400 6

14400 3 years 35.204(c) 1600 7

11200 3 years 35.205(d) 400 1

.400 3 years 35.310(b) 600 1

600 3 years 35.315(a)(4) 600.

1 600 3 years 35.315(a)(8)

• 00 0.2 120 u '" disposal auth'd 35.404(b) 600 1

600 3 years 35.406(b) 600 2

1200 3 years 35.406(c)-

600 1

600 3 years 35.406(d) includedin35.406(b)and(c) 35.410(b) 600 0.1 60 3 years 35.415(a)(4) 600 1

600 3 years 35.610(c) 240 0.1 24 3 years 35.615(d)(4) 240 2

480 3 years 35.630(c) 240 1

240 eqpt. duration 35.632(g) 240 1

240 license duration E

35.634(c) 240 12 2880 3 years 35.634(f) 240 12 2880 3 years 35.636(c) includedin35.634(f) 3 years 35.641(c) includedin35.634(f) license duration 35.647(c) 50 0.2 10 license duration Total Recordkeepnrs:

2,400 l

l Total Recordkeeping Burden:

284,156 hours0.00181 days <br />0.0433 hours <br />2.579365e-4 weeks <br />5.9358e-5 months <br /> L

p TOTAL BUR 0EN, 10 CFR PART 35: 302,944 hours0.0109 days <br />0.262 hours <br />0.00156 weeks <br />3.59192e-4 months <br /> TOTAL BUR 0EN, NRC FORM 473:

150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br /> l-1

• These documents are prepared as a written report and must be retained by the licensee for reference. The time spent making the record is included in the noted reporting section.

17 1

o I';

i e

.c.

Estimated Cost to Public to Respond j

[

]

Section Annual Cost to Respond 35.12(b)'

See OMB Clearance No. 3150-0120

]

35.12(c)

See OMB Clearance No. 3150-0120 2

35.13

$253,500 35.14 6,500 35.20 includedin35.12(b)and(c) e t

35.21(b)(2) includedin35.12(t,)and(c) 35.22(a)(A)and 572,000 (a)(5) 35.23(b).

includedin35.12(b)and(c) 35.27(a)(1) 9,750 35.27(a)(2) 9,750 35.27(c) includedin35.27(a) 35.29(b) 3,250 35.31(b) 78,000 35.33(a) 325-35.33(b) 3,000 35.33(c) 39,000 35.33(d) includedin35.33(b)and(c) 35.50(b)(4) includedin35.50(e)(4) 35.50(e)(1) 4,680 35.50(e)(2) 31,200 35.50(e)(3) 312,000

'J).50(e)(4) 24,700 35.51(d)&(a)(3) 62,400 35.53(c) 1,300,000 35.59(a)-

78,000 25.59(d) 312,000 35.59(e) 130 35.59(g) 624,000 35.59(1) 31,200 q

35.60(b)-

252,525 18

3.

.g if ?c'

{

Section Annual Cost-to Resoond 35.61(b) 378,560 35.70(d) 3,250 35.70(g) 250 35.'0(h) 12,480,000 3's.80( f) '

104,000 35.92(b) 936,000

'35.204(c) 728,000 35.205(d) 26,000 39,000'

'35.310(b) 35.315(a)(2) 109,200 35.315(a)(4) 39,000-35.315(a)(8) 7,800 35.315(b) 65 35.404(b)

.39.000 35.406(b) 78,000 35.406(c)

-39,000 35.406(d) includedin35.406(b)and(c)

.35.410(a) 39.000 f

35.410(b) 3,900 l-35.415(a)(2) 52,000 35.415(a)(4) 39,000 35.415(b) 65 1

35.606 2,600 35.610(a) 2,600 35.610(c) 1,560 35.615(d)(4) 31,200

'35.630(c) 15,600 35.632(g) 15,600

-35.634(c) 281,125 35.634(f) 187,200 35.636(c) includedin35.634(f) 35.611(c) includedin35.634(f) 35.643(a) 130 It

j

?

I Section Annual Cost to Ratond 35.643(b) 130 35.645 975 35.647(c) 650 Total

$19,653,276, NRC' Fo m 473 49,750 Source of Burden and_ Cost Data and Method of Estimating and Cost The estimates are based on submittals to NRC in past years and NRC experience l

since the implementation of revised Part 35 and the adoption of NRC form 473.

j Cost to licensees and applicants is calculated at an average rate of $r3.00 per j

hour. This figure includes both salaries and overhead.

[

Estimate of Cost to the Federal Government

' Application review activities art attributable to and reported under NRC form i

313, OMB Clearance No. 3150-0120.

Annual Cost of NRC staff.'eview for activities other than application review (Professional effort is 300 hours0.00347 days <br />0.0833 hours <br />4.960317e-4 weeks <br />1.1415e-4 months <br /> 9 $86.00 (hr)). = $25,800

[

P Reason-for Change in Burden l

The burden has been reduced sincs the last clearance because of a small decrease in the number of affected licensees and because of recalculation of burden estimates. Each of the burden estimates was recalculated based on the experience of the NRC staff and licensees in working with the new requirements.

L In a number of cases, adjust.nents were found to be necessary to the number of licensees re:ponding to a requirement, to the number of responses made annually l

by a respondent, to the burden for responding, or a combination of those

, factors. The ;sult of the recticulation is a substanual decrease in estimated br Jen on the public.

20

. ~..

.