ML20126G684

Request for OMB Review & Supporting Statement Re 10CFR35 Re Medical Use of Byproduct Material.Estimated Respondent Burden Is 27,257 H

ML20126G684
Person / Time
Issue date:	12/28/1992
From:	Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0010, OMB-3150-10, NUDOCS 9301040197
Download: ML20126G684 (27)

Text

_

l'

~

t m c m a mua.sm , pD f . .c&1emUoy0 MWb 5'*"*'"'*83 Request f ar OMB Review l fiev Septemtwrr1963)

Important Read instructions before completing form. Do not use the same SF 83 Send three copies of this form, the material to be reviewed, and for to request botn an Executwe Order 12291 review and approval under paperwork-three copies of the supporting statement, to:

the Paperwork Reduction Act.

Answer all questions in Part 1. If this request is for review under E.O. Office of information and Regulatory Affairs 12291, complete Part ll and sign the regulatory certification. If this Office of Management and Budget teouest is for aoproval under the Paperwork Reduction Act ano 5 CFR Attention: Docket Library. Room 3201 1320, skip Part 11, comptete Part til ana sign the paperaork certification. Washington DC20503 PART l.-Ccmplete This Part for All Requests.

.. Departrn;nt/ agency and Bureau /othce enginstarg request 2. Agency cooe U. S. Nuclear Regulatory Commission 3 1 5 0

3. h;me of person eno can oest answer cuestions rega'oing tnis recuest . Telephone numcer Dr. Donna-Beth Howe (301 ) 504-2636

4. Tiiie of information conectron or ru emaning 10 CFR Part 35 - Medical Use of Byproduct Material a, Ler,mi autnanty ter inforrmation cot'ection or r#,(cire unifeo Wafes Cooe, Puoi c ca+. or faccutive Order) 42 use 2201(o) c, J, Affected puolic f cheen afi tr'at appiv) 5 h Federalagencies or employees

C andnticuais or n0usanoids 3 Farms 6 h Non-orof;tinstitutions 2 [ Stata orlocalcove?meMs 4 Businesses or otnee for profit 7 h $ mail bus nesses or orRani28t;ons

> ART li -Complete This t) art Omy it the Reauest is for OMB Review Under Executive Order 12291

' Reguillion

. Identitrer Numoer iRIN)

~~ _ _ _ . cr, hone assvec C L Trpe at suomson t o'een one on eacn c1:rgow Type of review requested Classincation Stage et dewelopment 1 C Stancaro 1 C Maior 1 C Proposeoorcran 2 C Pencing 2 C flonmaior 2 C Fiaalorintenmtmat.witnortorproposal 3 C Emergency 3 C Final or intenm final without onor proposal 4 O statutoryoriuciciaideaanne

3. CFR section attecteo CFP

10. Does tnis regutation contain reporting or recoroneeping recurements tnat reovire OMB approvai unoer tNPaoerwork Reduction Act and 5 CFR 1320? - C Yes C th _

l,1. If a msior rule is tnere a regulaton ' m" t anaiysis attachec ? 1 C Yes 2 C No if No." ed OMB waive tne ana:ysn ' 3 C Yes 4 C No Oertification for Regulatory Submissions M submittir's tms request for oMB review, tne autnorrzed regulatory contact a .c the orogram official certify tnat the requirements of E.o.12291 and any apphcacie

?Jiicy cliectives nave been comoited with igrature of program eftscial Date ignature of authorizeo reguiatory contah h Date h

9301040197 921228h 12* pa use oniy, PDR ORG EUSOMB j ' 1

~ PDR:~

5evious edit ons cosolete . g3.gog standard Form a3 (Rev. 9 83)

PrescnDed by OMB

(

NSN 754o.00 634-4034 '

5 CFR 1320 and E 0 12231

I f

l - PART lli.-Complete This P;rt 0:<ly if the Reorost is for Appr: val cf c C:ll:cti:n 1

! of Information Under the Paperwork Reductlin Act and 5 CFR 1320. *

)

' Ma#dl@o@TifWf,11NdS&#(WRat'erf'8%huclear Medicine" 10.CFR Part 35 contains requirements that apply to NRC licensees who are authorized to administer

. byproduct material or its radiation to humans for medical use. The information in the required reports and-records is used'by NRC to make licensing and regulatory decisions to. ensure protection of the public health and safety.

14. Type of mtormation co0ection (check only or e)

IUormation collections not contained m rules 1 C Regular submission 2 O Emergency subrtiission(certe/scorro9 attached) 8:Jormation collectoons contained in rules 31 Existing regulation (no change propose:) 6 Final of mtenm tmai witnout prior NPRf> 7. Enter cate of expected or actual Feceral 4 O Notice cf proposed rutemakmg(NPRM) A O Regular subm'ssion Register pubiscation at this stage of rulemakmg 5 O Finat. NPRM was previously p.bbsned B O Emergency submission tcertsrication attached) (mor'tri. cay. tra').

15. Type of review reouested (check onirone) 1 O Hew conecton 4 O Remstatement of a oreviously sooroveo collection for which approval 2 L Revision of a currentiy approved collection " '"#

3 0 triensen of tne expiration date et a current >y approved coiiect.on 5 0 taisting conect on in use witnout a, oMB controi number minout ery enance m the substance or m tne metnoo of coi.ection 1 S. Agenty report form numoerts)(unclude stancarnicotional form numtser(s)) - 22. Purpose cf mtormation conection (check as many as apply) 1 O Appncation for benefits Not applicable 2 O P,ogram evaivaten

17. Annusi reportmF or cisclosure burpen 3 0 cen raipurpose statistics 1 Numoer et respondents , 1900 : 4 @ Reguintory or comonance 2 Number of responses per responcent  ! 1695.11  !

5 O Prog amplannmgo managemee 3 Teto annue resoonses ame I rimes eme 2;  ! 3.220.707 I e O Reswcw 4 Hcurs per responsa i .01 i- 7 O Auzt

- $ TotN hoW (Me 3 tmet hne J) i 21.571 i

16. Annualrecoroneepmg nurden 23, i recuency at recer0*eeping or reporting (checa all tnat appfy) 1 Number of recorcueepers 1900 i g Reco,0,eeorg 2 Annual hours per recoroveeper. .

Ik2.44 Reportmg 3 Tot # recoraneeping hours (tine J times Jme 2) .! 308.630 !

vwy 2 g en occas1er .

4 R corakeerme retenten oe me 3 years to. duration 3 y w,e i, 2 9. Total snnuai euroen of IiCense i 4 O Montniy 1 Rrquested (ime 17 5 prus tine 1s 3) . 330.201 i 5 0 ouarteny.

2 ncurrentoMBinventory 302.944 '

s O semiannusiy 3 Ditterence(ime J iess Jme 2) + 27.257 7 O Annuey boianation of ditterence . 8 O B,enn,aisy 4 Program enange .

9 E .otner(cescr oe). Renewals everv 5 years s Aoiustment : 1 + 27.257 !

20. Current (most recent) OMB contro6 number or comment numDec 24. Resconcents' ochgation to cornpiy (enecA t9e strongest obligation thatapplies) 3150-0010 1 O vo!unta,y

21. Recuxsteo eioiration cate 2 O Required to obtain or retam a benefit 3 years from approval date a O Mane, tory

25. Are tne respondents pnmarHy educational agencies or institutions or is the pnmary purpose of the coliection related to Feoeral education programs? O ves p Ne 2s. oc ;s tne agency use samphng to seiect resoondents or does tne agency recommend or prescribe tne use o+ samoims or statisticai anaiysis by respondents . O yes p No

27. Reguatory autnonty for tne information conection 10 CFR Part 35  ; or FR .; or, other (specify)-

Paperwork Certification

.In submittmg this request for oMB approvat, tne agency head, the senior off:cial or ari authorized representative, certifies tnat tne requirements of 5 CFR 1320. the Prreacy Act. statistical standaros or directives, and any other applicabie information pohey directives have been comphed with.

- Signature of program officia4 Date rtture

.1 w w /2 3e'seher' .,.c-AZ 'lOrt$resentative

) Date eral . . . nford, signa Senior Official for Informatipit R sources nagement OYW O CPO 1984 o - 453-776

t , ,

SUPPORTING STATEMENT FOR 10 CFR PART 35 MEDICAL USE OF BYPRODUCT MATERIAL (3150-0010)

Description of the Information Collection 10 CFR Part 35, Medical Use of Byproduct Material, contains requirements that apply to Nuclear Regulatory Commission (NRC) licensees who are authorized to administer byproduct material or its radiation to humans for medical use.

A. 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 perform certain 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 matters are of J 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 applicant's complete radiation safety program. Requests for amendments and-license renewals may be submitted in letter format. This report is needed to assure NRC that the applicant has programs in place adequate to protect health and minimize danger to life and property before NRC can authorize receipt of radioactive material. NRC Form 313 has previously been cleared under OMB No. 3150-0120, which should be referred to for additional supporting information, as well as burden and cost data.

Section 35.13 requires that licensees apply for and receive a license amendment before using material not allowed by the license, before adding to or changing key individuals, before receiving more material than allowed by the license, or before changing the area or addresses of use. The triggering events are critical indicators of a potential for change in the licensee's ability to control radiation dose to workers and the public, or the NRC's ability to contact the licensee or conduct an inspection of the licensee's program. The information is needed so that the 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 of public health and safety.

Section 35.14 requires that licensees notify the NRC within 30 days if-a key worker ends his association with the-licensee or has a name change, or when the licensee's mailing address changes. This prompt report is needed because if the licensee no longer has a complete staff, or has moved to a different location, the collective training _and experience of the remaining staff or the provisions and characteristics of the facility may no longer be sufficient to ensure. safety. This report will trigger a check of the licensee's file to determine whether,the licensee's remaining users are qualified to receive and use radioactive material safely, or whether a new location will permit safe possession and use of the material.

Section 35.20 requires licensees to have a written program to keep radiation dose as low as reasonably achievable. The program must be written to provide clear statements of authority, responsibility, and technical requirements. The written program is used by the licensee, the Radiation Safety Officer, and authorized users. Its purpose _is to ensure that licensees comply with the requirement to make a reasonable effort to maintain individual and collective occupational radiation doses as low as reasonably achievable.

Section 35.21(b) (2) requires that the licensee establish and implement-the written policy and procedures that were submitted as part-of the application. The written policy and procedures are needed so that the staff can review them and make a determination that the applicant can meet the requirements of the Atomic Energy Act and the Commission's regulations. The procedures must be implemented in order to provide for protection of the public health and safety. The burden is-included in the burden for the application, NRC Form 313, OMB No. 3150-0120.

Sections 35.22 (a) (4) and (5) 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 program.

Section 35.23(b) requires that licensees provide a written statement of authority, duties, responsibilities, and radiation safety activities for the Radiation Safety Officer and Radiation Safety Committee. The statement is needed so that managers and

~

key users know their responsibilities. The statement must be retained for the duration of.the license.

Section 35.27(a) requires that licensees provide written per-mission to visiting _ authorized users to work:under the license.

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 racord are needed to show that

. licensee management has ptn. tted this work, and that a 2

l'

regulatory agency has reviewed and approved-the visitor's training and experience.

Section 35.29(b) requires that mobile nuclear medicine service 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) requires that licensees make a record of minor radiation safety program changes. This record is needed.to show what radiation safety factors were considered before implementing the minor change. This permits NRC to evaluate the nature and appropriateness of the minor changes during inspections prior to renewal and provides the licensee with a complete record of the radiation safety-program until the changes are incorporated into the license at renewal.

Section 35.32 contains requirements for a quality management program.

Section 35.32(a) requires that each applicant or licensee establish and maintain a written quality management program.

Section 35.32(b) requires that the licensee develop audit procedures, revise the quality management program when necessary, and retain records of each audit and management evaluation of the quality management program for three years.

Section 35.32(c) requires that the licensee retain records of the relevant facts of recordable events for three years.

Section 35.32(d) requires that the licensee retain records

-of written directives and administered radiation dose or '

radiopharmaceutical dosage for three years.

Section 35.32(e)' allows the-licensee to make modifications to the quality management program to increase the-program's efficiency and requires that the modification be submitted to the NRC Regional Office within 30 days.

Section 35.32(f) (1)' requires that an applicant for a new license submit a quality. management program to the NRC Regional Office as part of the license application.

Section 35.32 (f) (2) requires that an existing licensee submit a certification that the quality management program has been implemented, along with copy of the program, to the NRC Regional Office by January 27,-1992.

Sections 35.32(a), (b), (c), (d), (e), (f)(1) and.(f)(2) are cleared separately under OMB No. 3150-0171. They are described here for information purposes only.

3

Section 35.33(a) requires:

(1) that the licensee notify by telephone the NRC Operations Center in case of a therapy 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 misaamin-istration may present a clear and present radiation hazard to a member of the public that might be mitigated by NRC assistance.

(2) that a licensee file a written report to NRC within 15 days after discovery of a misadministration. This report is needed so that NRC can determine whether there might be generic implications in the incident which indicate a need to notify all licensees. NRC allows the licensee 15 days to submit the report so that it can review and analyze what has happened and provide NRC with a complete history of the event. NRC requires submission of the report within 15 days so that it can promptly notify other licensees if it appears the precipitating event might be generic.

(3) that the licensee notify the referring physician and the patient or a responsible relative (or guardian) of the patient unless contraindicated by factors known to the referring physician. These reports are needed so that adequate care may be provided for the patient.

Section 35.33(a) is cleared separately under OMB No. 3150-0171.

It is described here for information purposes only.

Section 35.33(b) requires that the licensee retain a record of each misadministration for five years. These written records are needed to determine what kinds of actions precipitate misadminis-trations, and also provide an indicator of the licensee's management control of the radiation safety program. This section is cleared separately under OMB No. 3150-0171. It is described here for information purposes only.

Section 35.50(b) (4) requires that licensees make a record of a geometry dependence test for the dose calibrator. This record is needed to demonstrate the relationship between volume configurations of the radiopharmaceutical and the accuracy of the reading given by the dose calibrator so correction factors, if applicable, can be applied.

Section 35.50(e) requires that licensees retain a record of checks and tests of dose calibrator performance. This record is needed to show that the dose calibrator is functioning correctly and is capable of accurately measuring radiopharmaceutical dosages, to establish trends in equipment performance, and to show compliance with regulatory requirements.

Section 35. 51(a) (3) requires that the licensee note on a survey instrument the apparent exposure rate from a dedicated check 4

l .

source at the time of instrument calibration. This information i _is needed so the licensee can check-the survey instrument for proper operation before making measurements. The burden is l included in the burden estimate for section 35.51(d).

1 3 Section 35.51(d) requires that licensees retain a record of

survey instrument calibrations. Thic record is needed to show i that survey instruments were calibratad and operational.

Section 35.53(c) requires that licensees retain a record of each

^

radiopharmaceutical dosage measurement. This record is needed for licensees to show that they are maintaining control of the use of radiopharmaceuticals.

Section 35.59(a)' requires that licensees mairttin the

manufacturer's written instructions for the tafe use of sealed

sources and brachytherapy sources. These instructions are needed j

so that individuals who are handling sources can determine the specific safety measures appropriate _for each kind of source used.-

Section 35.59(d) requires that licensees retain _a record of sealed source leak tests. This record.is needed to-show that the l leak test was done at the appropriate _ time, and that the test i showed that the source was not leaking.

$ Section 35.59(e) (2) requires that licensees file a report with-i the NRC within 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 3 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. NRC requires submission of the report within 5 days so that it can-promptly i'

notify other licensees if it appears there may be~a generic problem.

Section 35.59(g) requires that licensees make a-record of seared-source and brachytherapy source inventory., This inventory is needed to show that possession of sealed sources did not exceed the amount authorized by the license. The five-year recordkeeping requirement will help to assure continued control-

-over these sources that are only occasionally used.-

Section 35.59(i) requires that licensees make a record of i radiation surveys of areas where sealed sources and brachytherapy sources are stored. This record is needed to show that-adequate

~

radiation shielding has been provided for such sources, and that dose rates in contiguous areas are within allowed levels.

Section 35.60(b) requires that licensees label each syringe or syringe radiation shield as-to its contents. This label is needed because review of misadministration reports has indicated 5

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

. ~ - _- - .

j .

1 ,

i

! that in many cases misadministrations are caused by inadvertent transposition of syringes.

Section 35.61(b) requires that licensees label vial radiation shields with the identity of the radiopharmaceutical contained.

NRC review of several misadministration 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.

Sections 35.70(d) and (g) require that the licensee establish 4

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.

4 The sections also require that the licensee immediately notify the Radiation Safety Officer if excessive levels are detected

during a survey. This report is needed so that the Radiation Safety Officer can take appropriate remedial action. The j Radiation Safety officer is the primary indiviuual onsite who is qualified to determine what action is needed to ensure-worker and 4 public health and safety, and whether that action is needed

) immediately or can be delayed.

i Section 35.70(h) requires that licensees retain a record of l radiation surveys. The record is needed to show that the

required surveys were made.

1 l Section 35.80(f) requires that mobile nuclear medicine service 4

licensees make a record of radiation surveys. The record is 1' needed to show that the required surveys were made.

Section 35.92(b) requires that licensees make a record of disposal of waste that was decayed in storage. The record is needed to show that materials were decayed for.the proper length of time and that a proper survey of each waste container was made prior to disposal.

i 4 Section 35.204(c) requires that licensees retain a record of i molybdenum-99 concentration in radiopharmaceuticals. This record is needed to show that the' concentration measurement was made and that the maximum molybdenum-99 concentration level was_not exceeded.

t Section 35.205(d) requires that the licensee post-a time period of evacuation'in areas where radioactive gases are used. In case of a spill, this provides notice to workers of how much. time air-

-handling equipment needs to reduce the air concentration to permissible limits. The licensee must retain a record of the calculations used to determine the evacuation time for the duration of use of the. area.

4 Section 35.310(b) requires that licensees retain a record of I

radiation safety instruction given to personnel wru) care for 6

mm ,n , , - ,,r. --- -n--, .- ,-+- g , ,

l

• I radiopharmaceutical therapy patients. This record is needed to show that the training was given.

Sections 35.315(a) (2) requires that tne licenseo post l radiopharmaceutical therapy patient room doors with a i

" Radioactive Materials" sign. This provides notice to hospital j 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 patient's room. This is l the most convenient way to provide this information to nurses, who are usually responsible for enforcing visiting rules.

Section 35.315 (a) (4) requires that licensees make a record of dose rates around radiopharmaceutical treatment rooms. This record is needed to show that members of the public are not exposed to excessive levels of radiation.

Section 35.315(a) (8) requires that licensees make a record of the thyroid burden measurement of each individual-who helped prepare or administer a therapeutic dosage of iodine-131. This record is needed to show that the required measurement was performed and that workers were not exposed to excessive levels of iodine-131.

Sections 35.315(b) requires that the licensee promptly notify the j Radiation Safety Officer if the radiopharmaceutical therapy

patient dies or has a medical emergency. This report is needed l so that the Radiation Safety Officer can take whatever actions are necessary to prevent a spread-of radioactive contamination or

! loss of brachytherapy sources. The Radiation Safety Officer is

! the primary 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.

1 Section 35.404(b) 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 i was made.

Section 35.406(b) requires that licensees make a_ record of

, brachytherapy source use. This record is needed so that, if a brachytherapy source is misplaced or missing, the licensee is

! immediately alerted and can take appropriate action.

Section 35.406(c) 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.

Section 35.406(d) requires that the licensee retain a record of the use of brachytherapy sources and special safety surveys.

, This record is needed to show that the licensee is providing adequate control for these sources. The record burden is I

included in the burden estimate for_ Sections 35.406(b) and (c).

I 7

i I

d Sect 3on 35.410(b)-_ requires that licensees retain a record of

- training for personnel-who care for implant patients. This record is needed to show that the train.ng was given.

Section 35.415(a)(2) requires that a licensee post the patient's i door with a " Radioactive Materials" sign and note on the door ~or in the patient's chart where and how long visitors may stay in

! the patient's room. This posting is needed to help protect

against excessive radiation exposure to visitors, i

Section 35.415 (a) (4) requires that, after an implant cf 3

radioactive material, licensees record the results of a survey of i the contiguous restricted and unrestricted areas and retain the l record for three years. The record is used to demonstrate

compliance with 10 CFR Part 20 requirements and to show that i members of the public are not exposed to excessive levels of radiation.

Section 35.415(b) requires that the licensee notify the Radiation Safety Officer immediattly if the 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 sources. The Radiation Safety Officer is the primary 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.

i Section 35,606 requires that licensees apply'for and receive a

, license amendment before making certain changes in the l teletherapy program. This license amendment process is necessary i because the licensee might consider making changes that would

cause radiation levels in restricted and. unrestricted areas to exceed permissible levels.

l 1

Section 35.610(a). requires'that licensees post-written instruc-I tions for individuals who operate teletherapy units. These

instructions are needed to remind workers of proper operating procedures and to serve as a quick reference-in: case of i emergencies or equipment malfunction.

, Section 35.610(c) requires that licensees make a' record of training for individuals who operate-teletherapy < units. This-

< record is needed to show that the training was given.-

i 1~ Section 35. 615 (d) (4) requires that licensees retain a record of the teletherapy room radiation monitoring device function check.

. This record is needed to show that.the check.was made.

< Section 35.630(c) 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 made with instruments capable of making accurate measurements.

8

2 Section 35.632(g) requires tr'.t licensees retain a record of teletherapy unit calibration. This record istneeded to show that the calibrations were done and that licensees did not inadvertently administer incorrect radiation doses to patients.

Section 35.634(c)-requires that the qualified teletherapy physicist report the results of teletherapy unit spot-checks promptly to the licensee. This assures the licensee that the results of each spot-check have been reviewed by an expert. The licensee must keep a copy of each report to assure that the review has been made.

Section 35.634 (f) requires that licensees retain a record of spot-checks. This record is needed to show that the required checks were made.

Section 35.636(c) requires that licensees retain a record of safety checks for teletherapy facilities.- This record is needed to show that the checks were made.

Section 35.641(c) requires that licensees retain a record of radiation measurements after installing 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 permissible limits.

Section 35.643 (a) (3) requires that licensees include additional survey and facility description information if. changes in an NRC approved installation were necessary for compliance with Part 20.

1 The additional information in the report will facilitate a i determination by NRC that dose rates in restricted and

• unrestricted areas are within permissible limits. The 30-day submission requirement is contained in Section 35.645.

i

! Section 35.643(b) requires that licensees request a license amendment if the licensee wants authorization for radiation levels in unrestricted areas which are above permitted levels.

This report will trigger an indepth NRC review of safety considerations before it-allows a licensee to operate the unit.

The 30-day submission requirement is contained in Section 35.645.

Section 35.645 requ' ires that licensees mail a copy of' teletherapy source installation records to the NRC. These records are 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 requirement is imposed because of the especially high dose rates that can be found around. teletherapy units.

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

9

(-

l

-- - - = - . . . . _ - - - - - - . ~ .

i t

Reductionlof Burden Throuch Information Technoloay 1

i 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 information technology for submission.

Effort to Identify Duolication The Information Requirements Control Automated System (IRCAS) was

' searched to determine duplication.- None was found. In general, 4

information required by NRC in applications, reports, or records

. concerning the_ transfer, receipt, possession, or use of byproduct material does not duplicate other Federal information collection

. requirements and is not available from any source other than i applicants or licensees. Portions of the needed information

. might also be contained in other information submittals to NRC or other Federal agencies. However, duplication, if any, is slight, and the collection of this information by use of specified forms 4 and other required reports and records is the most effective and least burdensome means of obtaining the information.

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

! Effort to Reduce Small Business-Burden The majority of licensees who use byproduct material are small businesses. Since the health and safety consequences of improper handling or use of radioactive byproduct material 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.

4 Consecuences of Less Frecuent Collection i

? Required reports are collected and evaluated on a continuing basis as events occur. Applications for new licenses and amendments are submitted only once. Applications for renewal of licenses are submitted every five years. The schedule for collecting the information is the minimum frequency necessary to assure _that licensees will continue to conduct programs in a manner that will assure adequate protection of the public_ health

. and safety.

Circumstar.ces Which Justifv Variation from 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. This1 prompt report is needed because if the licensee no longer has a complete 10

'4 staff, the collective training and experience of the remaining staff may no longer be sufficient to ensure safety. This report will trigger a check of the licensee's file to determine whether the remaining key users are qualified to receive and use material safely.

Section 35.20 requires licensees to retain, for the duration of the license, a written program to keep radiation dose as low as reasonably achievable. The written program must be retained so that it can be used by the licensee, the Radiation Safety Officer, and authorized users throughout the period of the license to ensure that a reasonable effort is made to maintain

individual and collective occupational radiation doses as low as j reasonably achievable.

Section 35.21(b) (2) requires that the licensee establish and implement the written policy and procedures that were submitted as part of the application. It is necessary that the policy and

! procedures be retained for the duration of the license so that they.will be available to the licensee's staff for-implementation and so that the NRC staff can review them to ensure that the applicant can meet the requirements of the Atomic Energy Act and 1

the Commission's regulations for-protection of the public health and safety.

Sections 35.22 (a) (4) and (5) require that medical institution j

licensees retain a copy of Radiation Safety Committee meeting i

minutes for the duration of the license, and prescribe the information required in the minutes. Retention of the records 4 for the duration of the license is needed to show continuing management oversight of the radiation safety program.

Section 35.23(b) requires that licensees retain, for the duration of the license, a written statement of authority, duties, responsibilities, and radiation safety activities for the Radiation Safety Officer and Radiation Safety Committee.

Retention of the statement for the period of the license is necessary so that managers and key users know their responsibilities.

Section 35.31(b) requires that-licensees retain a record of minor ra'diation safety program: changes until. license renewal or termination. This record is needed to:show what radiation. safety factors were considered before implementing the minor change.

This permits NRC to evaluate the nature and appropriateness of the minor changes during inspections prior to renewal and provides the licensee with a complete record of the radiation safety program until the changes are incorporated into the license at renewal.

Section 35.32(a) requires that each applicant or licensee establish and maintain a_ written quality management program for the duration of the licensed activity. Section 35.32(a) is cleared separately under OMB No. 3150-0171.

11

s I

Section 35.33(a) requires:

(1) that the licensee notify by telephone the NRC Operations l Center in case of a therapy misadministration within 24

) hc'urs after discovering the misadministration. This prompt j notification is necessary because a therapy misadmin-

} istration may present a clear and present radiation hazard i to a member of the-public that might be mitigated by NRC assistance.

(2) that a licensee file a.writtr.n report to NRC within 15 days af ter discovery of a misad ainistration. This report is needed so that NRC can determine whether there might be

generic implications in the incident which indicate a need to notify all licensees. NRC allows-the licensee 15 days to submit the report so that it can review and analyze what has i, happened and provide NBC with a complete history of the event. NRC requires submission of the report within 15 days so that it can promptly notify other licensees if it appears j the precipitating event might be generic.

Sectioi. 3 5. 3 3 (b) requires that the_ licensee retain a record of each misadministration for five years. These. written recordstare needed to determine what kinds of actions precipitate misadminis-

trations, and also provide an indicator of the licensee's management control of the radiation safety program.

. Sections 35.33(a) and (b) are cleared separately under OMD No.

3150-0171.

Section 35.50(b) (4) requires that licensees retain a record of a 4

geometry dependence test for the dose calibrator for the duration of use of the dose calibrator. This-record is needed_throughout the duration of use of the equipment to demonstrate the j relationship between volume configurations of the radio-i pharmaceutical and the accuracy of the reading given by the-dose calibrator, and would be necessary for subsequent reconstruction in the-event of an incident involving questions of-dose

{ calibration.

Section 35.50(e) requires'that licensees retain a record of checks and testsLof dose calibrator performance for the duration 4 of use of-the equipment._ This record is needed throughout the

} duration _of use of the equipment to show that the dose calibrator is functioning correctly and is capable of accurately measuring-radiopharmaceutical dosages, andLto establish trends in equipment performance.

Section 35.59(a) requires that= licensees maintain, for the duration of source use,'the manufacturer's written instructions for the safe use.of sealed sources and brachytherapy sources.

+

These instructions are needed so that, at any time during the duration of use, individuals.who are handling sources can 12 2

1 -

3

+

I J

determine the specific safety measures appropriate for each kind

of source used.

1 Section 35.59(e) (2) requires that licensees file a report with the NRC within five days if leakage of a sealed source is i detected. This report is needed so that NRC can make a l determination as to whether other licensees who have similar i 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. NRC requires submission of the report within 5 days so that it can promptly notify other licensees if it appears there may be a generic l

problem.

i Section 35.59(g) requires that licensees retain a record of sealed source and brachytherapy source inventory for five years.

This inventory is needed to show that possession of sealed sources did not exceed the amount authorized by the license. The i five-year recordkeeping requirement is necessary to assure con- 2 4 tinued control over these sources that are only occasionally

! used, and to ensure that the records will be available for

j. periodic inspections, which may exceed a three year interval.

Section 35.205(d) requires that the licensee retain, for the l

duration of use of the area, a record of the calculations used to

! determine the evacuation time for areas where radioactive gases

! are used. In case of a spill, the record of the calculations, j which is required to be posted, provides notice to workers of how 4 much time air handling equipment needs to reduce the air concentration to permissible limits. This record is also needed

to show that the calculations were performed. Retention beyond three years is necessary to provide notice of evacuation time-to workers and to ensure that records of calculations are available e to the NRC for periodic inspections, which may exceed three year j intervals.

Section 35.315 (a) (8) requires that licensees retain a record of the thyroid burden measurement of each individual who helped prepare or administer a therapeutic dosage of iodine-131 until i the Commission authorizes their disposition. This record is needed to show that the measurement was performed _and that

' workers were not exposed to excessive levels of iodine ,131.

Retention beyond three years is necessary to ensure that complete records of exposure of each individual are available to the individual and to the licensee so that the licensee can avoid accumulation of excessive exposures by individuals.

Section 35.415(b)_ requires that the licensee notify the Radiation

-Safety Officer immediately if the patient dies or has a medical emergency. This immediate notification is necessary to permit-the RSO to ensure that safety requirements are met for removal or l~ disposal of the implanted radioactive material.

i. 13 i

i sectien 35.630(c) requires that licensees retain a record of each 4 calibration, intercomparison, and comparison of teletherapy dosimetry equipment for the duration of use of the equipment.

These records are needed to show throughout the period of use of the equipment that measurements of radiation teletherapy doses l were made with instruments capable of making accurate measurements, and for use in reconstruction in case of an <

incident.

! Section 35.632(g) requires that licensees retain., for the

! duration of the license, a record of teletherapy unit l calibration. This record is needed to show that the calibrations were done and that licensees did not inadvertently administer

)i incorrect radiation doses to patients. It would also be needed i

e in the case of reconstruction of an incident. .I j

i Section 35.641(c) requires that licensees retain, for the l duration of the license, a record of radiation measurements aftov '

installing a source in a teletherapy unit. These records are needed throughout the period of the license to provide assuranca i that the source was properly installed within the teletherapy unit, and that dose rates outside the teletherapy room are wD d n ,

permissible limits. They would also be needed-in reconstruck sn j 4

following an incident involving the unit.

i 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 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 requirement is imposed because of the especially high dose rates that can be found around teletherapy units.

I Section 35.647(c) requires that licensees keep a record of teletherapy unit inspection and servicing for the duration of the d

license. This record is needed throughout the period of licensed

. activity to show that the required work was done-anc to estatlish a service history which may be used in incident investigations and evaluation of generic equipment problems.

4 Consultations outside the Acency i

During this clearance period, there have been consultations with

. -the Advisory. Committee on the Medical Use of Isotopes (ACMUI), a group which< includes a number of representatives of the licensed medic .1 cummunity, which provided its advice tct the NRC .staf f.

There have also been consultations with staff members of the Food and Drug' Administration (FDA) Center for Drug Evaluation and Research and the FDA Center-for. Biologics Evaluation and.Research on amendments to the rule and on supporting recordkeeping requirements, as well as public comments received on amendments to the rule.

14

Confidentiality Nono,-except for proprietary information.

Sensitive Ouestionq None.

Number and Tvoo of Respondents These requirements will affect approximately 1900 licensees and applicants. About 1500 of the licensees are hospitals, and about 400 of the licensees are physicians in private practice, -

15

4 Estimate of Comoliance-Burden

-Recortina Reauirements .

Licensee Total Annual No. of Licensee Staff Hours Licenseo Burden Section Responsen Annually Per Submittal (Hours) 35.12(b) See OMB Clearance No. 3150-0120 35.12(c) See OMB Clearance No. 3150-0120 35.13 1300 3 3900 35.14 200 0.5 100 -

3 5. 27 (a) (1) 300 0.5 150 3 5. 27 (a) (2) 300 0.5 150 3 5. 32 (f) (1) See OMB Clearance No. 3150-0171 3 5. 32 ( f) ( 2) See OMB Clearance Ns. 3150-0171 35.33(a) See OMB Clearance No. 3150-0171 3 5. 59 (e) (2 ) 1 2 2 35.60(b) 2,600,000 .00416 LO,816 35.61(b) 600,000 .00416 2496 35.70(d) 1900 0.02 38 35.70(g) 1900 0.02 38 3 5. 315 (a) ( 2 ) 8400 0.2 1680 35.315(b) 12 1 12 3 5. 415 (a) ( 2 ) 4000 0.2 800 35.415(b) 250 1- 250 35.606 40 2 80 35.610(a) 80 0.5 40 35.634(c) 1992 0.5 996 35.643(a)(3) 1 4 4 35.643(b) 1 4 4

35.645 30 0.5 15 1 Total 3,220,707 21,571 i_

16 I

t.

l

Recordkeenina Reauirements Total No. of Record- Record Record- Annual Hours keeping Rotention Spction kgeners per Recordkeener Hours Period 35.20 See 35.12 (b) and (c)* license duration 3 5. 21 (b) ( 2 ) See 35.12 (b) and (c)* license duration >

3 5. 2 2 (a) (4 ) & (5) 1500 8 12000 license duration 3 5. 2 3 (b) See 35.12 (b) and (c)* license duration-35.27(c) See.35.27(a)* 3 years after last use 35.29(b) 30 1 30 3 years after last servico 35.31(b) 000 1 900 license renewal or l termination l 35.32(a) See OMB Clearance No. 3150-0171 35.32(b)- See OMB Clearance No. 3150-0171 35.32(c) See OMB Clearance No. 3150-0171 35.32(d) See OMB Clearance No. 3150-D2

35.32(e) See OMB Clearance No. 3150-0171 35.33(b) See OMB Clearance No. 3150-0171 )

3 5. 50 (b) (4 ) See 35.50(e) (4) eqpt. duration 3 5. 50 (e) (1) 1800 0.03 54 3 years-3 5. 50 (e) (2) 1800 0.2 360 3 years 3 5. 50 (e) (3 ) - 1800 4 7200 3 years 3 5. 50 (e) (4 ) 300 1 300 eqpt. duration ,

3 5. 51 ( a) ( 3 ) & (d) 1800 0.4 720 3 years 35.53(c) 1800 48.3 87000 3 years 35.59(a) 1900 0.5 950 eqpt. duration 35.59(d) 1900 2 -3800 3 years 35,$9(g) 1900 4 7600 5 years 35.59(i) 1900 0.2 380- 3 years 35.70(h) 1900 80 -152000 3 years 35.80(f) _30 80 2400 3 years 17

j .

Recordkeenina Reauirements (Continued)

Total

! No. of Record- Record Record- Annual Hours keeping Retention 3 Section keepers per Recordkeeper Hours Period 1

1 3 5. 92 (b) 1800 6 10800 3 years 35.204(c) 1200 9.4 11280 3 years 35.205(d) 1200 1 1200 duration of use of area i'

35.310(b) 600 1 600 3 years 3 5. 315 (a) (4) 600 1 600 3 years

3 5. 315 (a) ( 8) 600 0.2 120 until disposal auth'd 35.404(b) 600 1 600 3 years 35.406(b) 600 2.3 1380 3 years

} 35.406(c) 6 C ;; 1 600 3 years

', 35.406(d) included in 35.406(b) and (c) f 35.410(b) 600 0.17 100 3 years i 3 5. 415 (a) (4 ) 600 1 600 3 years j 35.610(c) 170 0.1 17 3 years 4

3 5. 615 (d) (4 ) 170 2.6 442 3 years 35.630(c) 170 1 170 eqpt. duration i 35.632(g) 170 2 340 license duration i 35.634(c) 17^ 12 2040 3' years 3 5. 634 (f) 1.70 12 2040 3 years 4

.3 5. 6 3 6 (c) included in 35.634 (f) 3' years-35.641(c) included in 35.634 (f) license duration 35 647(c) 36 0.2 7 license duration i

Total Recordkeepers: -1,900 Total Recordkeeping Burden: 308,630 hourc l

i - TOTAL-BURDEN, 10 CFR PART 35: 330,201 hours0.00233 days <br />0.0558 hours <br />3.323413e-4 weeks <br />7.64805e-5 months <br /> i

i.

j

'oThesa 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.

l

'18 l I

Estimated Cost to Public to ResDond Section Annual Cost to Respond 35.12(b) See OMB Clearance No. 3150-0120 35.12(c) See OMB Clearance No. 3150-0120 35.13 $479,700 35.14 12,300 35.20 included in 35.12(b)-and (c) 3 5. 21 (b) (2) included in 35.12(b) and.(c)

35. 22 (a) (4) & (5) 1,476,000

35. 23 (b)~ included in 35.12 (b) and (c) 3 5. 27 (a) (1) 18,450 3 5. 27 (a) (2) 18,450 35.27(c) included-in 35.27(a) 35.29(b) 3,690 35.31(b) 110,700 35.32(a) See OMB Clearance No. 3150-0171 35,32(b) See OMB Clearance No.- 3150-0171-35.32(c) See OMB Clearance No. 3150-0171 35.32(d) See OMB Clearance No. 3150-0171 35.32(e) See OMB Clearance No. 3150-0171 35.32(f)(1) See OMB Clearance No. 3150-0171 3 5. 3 2 ( f) (2) See OMB Clearance No. 3150-0171 35.33(a) See OMB Clearance No. 3150-0171 35.33(b) -See OMB Clearance No.. 3150-0171 3 5. 50 (b) ( 4 ) included in- 35.50(e) (4) 2 5. 50 (e) (1) 6,642 3 5. 50 (e) (2) 44,280

. 35. 50 (e) (3) 885,600 3 5. 50 (e) (4 ) 36,900 3 5. 51(a) (3 ) & (d) 88,560 35.53(c) 10,701,000 35.59(a) 116,850 35.59(d) 467,400 35.59(e) 246 35.59(g) 934,800 35.59(i) 46,740 19

i ..

4 .

Section 7 Annual Cost to Respond i~

i

! 35.60(b) 1,330,368 35.61(b) 307,008.

l 35.70(d) -

4,674 ,

l 35.70(g) 4,674 -

j

' 18,696,000 35.70(h) ]

! 35.80(f) 295,200 l 35.92(b) 1,328,400 35.204(c) 1,387,440 f

l 35.205(d) 147,600 Y

35.310(b) 73,800

}

3 5. 315 (a) (2 ) 206,640 4 3 5. 315 (a) ( 4 ) 73,800 1

!- 3 5. 315 (a) ( 8 ) 14,760 l 35.315(b) 1,476 35.404(b) 73,800 f

!= 35.406(b) 169,740

! 35.406(c) 73,800' f 35.406(d) included in 35 406(b) and (c) 35.410(b) 12,300

^

3 5. 415 (a ) ( 2 ) 98,400 3 5. 415 (a) (4 ) 73,800

{

) 35.415(b) 30,750.

35.606 9,840 E

35.610(a) 4,920 h 35.610(c)' 2,091-

! 54,366;

- 3 5. 615 (d) (4 )

) 35.630(c) 20,910-

] 35.632(g) 41,820

-3 5. 6 3 4 '( c ) 3 7 3 , 4 2 8.-

35.634(f)- 250,920 d

j N=?

t E 20

. + , - - v-- . - _.n ,.r,-,,. --,,-.w- - . , - - -,w. n.-w.,ca_...., ae-w.-.,,v.,., -n. ., , un

e Eection bnnual Cost to Respond 35.636(c) included in 35.634 (f) 35.641(c) included in 35.634(f) 35.643(a)- 492-35.643(b). 492 35.645 1,845 35.647(c) 861 Total $40,614,700 Source of Burden and Cost Data and Method of Estimatina and Cosa The estimates are based on submittals to NRC in past years. Cost to licensees and cpplicants is calculated at.an average rate of $123.00 per hour. This figure includes both salaries and_ overhead.  ;

Estimate of Cost to the Federal Government Application review activities are attributable to and reported under NRC Form 313, OMB Clearance No. 3150-0120.

The " Quality Management Program and Misadministrations" information collection requirements are cleared under OMB No. 3150-0171.

Annual Cost of NRC staff review for activities other than application review (Professional effort is 300 hour0.00347 days <br />0.0833 hours <br />4.960317e-4 weeks <br />1.1415e-4 months <br />s-0 $123.00 (hr)) = $36,900.

Reason for Chance in Burden

'The revision is a net increase adjustment in burden resulting primarily from a reevaluation of the time required to perform individual activities and the number of times those activities are performed. For example, there-is an increased estimate of_the time

, required for the= labeling of syringes or syringe radiation shields as to their contents. At the same time, there is a decrease in the number of doses prepared by medical use licensees. A larger percentage of patient doses are obtained as unit doses-from commercial nuclear pharmacies-and do not require licensee _ preparation of labels for syringes, syringe shields,.or vials. There is also an increase 1 from a reevaluation of the number of licensees keeping records of l calculations of evacuation time in areas where radioactive gases are used, and an increase from a reevaluation of the time required for keeping records of radiopharmaceutical_ dose measurement. There are other factors resulting in decreases in burden for some requirements. l There is a decrease in the number of NRC medical use~ licensees (from J 2400 to 1900). There is also a decrease in burden because information collection requirements associated with the " Quality Management i Program and Misadministrations" rule are now covered by a separate  !

clearance, OMB No. 3150-0171. The result is a net increase of 27,257 hours0.00297 days <br />0.0714 hours <br />4.249339e-4 weeks <br />9.77885e-5 months <br />.

-j 21

j. ,

s ,

J- 4 , ,

3 j.

i i

i. (7590-01) t-p l =

1

NUCLEAR REGULATORY-ICOMMISSION i

s i

1 i.

l 4

} Doculaents Containing Reporting or_Recordkeeping i

e i Requirements: Office of Management and Budget (OMB)-Review i

. AGENCY

Nuclear ~ Regulatory Commission (NRC)

{

i

{

ACTION

Notice of OMB review of information collection.

t l- ,

l

SUMMARY

The NRC-has recently submitted to OMB for~ review the following l proposal for the collection of information under'the provisions-i- of th'e Paperwork R.sduction Act-(44 U.S.C.lChapterf35).

i

1. Type of submission, new, revision, or extension:- Revision.

i i=

1 L

2. The' title of:the information collection:-

I 10 CFR Part'35'- MedicalIUse of Byproduct ~ Material;

.t

3. The' form number ~if applicable:l1Not applicable.

4 _

s i.

~

- g -

v - - y . ,. - . < - .- .- J, ,,w k , ,#,, >- n,.... -.E.,,-~,,s-,w. O. - . 'd. c n r '4 +..'-e.ee,

- ....e. 4we=

~

- 2?- . _ _

4. How often the collection is required: Required reports are collected and evaluated on a continuing basis as events occur. Applications for new licenses or amendments may be -

submitted at any tima. Applications 1for renewal of licenses-are submitted-every five years.

5. Who will be required-or asked;to report: Physicians and medical-institutions who>are applicants for orfholders of an; NRC license authorizing the administration of byproduct material-or its radiation-tojhumans-for' medical use.

6. An estimate of'the number of responses annually:- 3,220,707

7. An estimate of the total number of hours-needed to complete the requirement or request: An average of 0.01 hours1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> per-response, plus approximately'162.44 hour5.092593e-4 days <br />0.0122 hours <br />7.275132e-5 weeks <br />1.6742e-5 months <br />s:per recordkeeper.

The total industry burden is->approximately1330,201 hours0.00233 days <br />0.0558 hours <br />3.323413e-4 weeks <br />7.64805e-5 months <br /> annually.

8. An indication of1whether-Section 3504(h), Pub. L.96-511 .

appl.i es : ' Not applicable.

1

.- l

~

k

([p '

y

9. Abstract: 10 CFR Part 35, Medical Use of Byproduct \ Material, contains requirements that apply to NRC licensees who are H

]

authorizedLto administer. byproduct material or its' radiation to humans for medical use. The informatic.: in the required reports, applications and records is used-by NRC torensure that the health and safety of the public is protected and that licensee possession and use of byproduct material is in compliance with license and regulatory requirements., The

{

revision is a net increase adjustment.in burden resulting-  ;

-primarily'from a reevaluation of'the time required to-perform' 1

-individual' activities and the number of times those

! activities are performed.

j-i

[ 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.

I <

I Comments and questions may be directed by mail tot the OMB reviewer:-

i:

' Ronald Minsk Office of1Information and. Regulatory Affairs (3150-0010)

[ a if NEOB-3019-Office of Management and Budget-B -Washington, DC 20503

• i i

i

_ _ _ . _ _ . - . . . _ _ . . _ . . _ _ . _ . _ _ . . . .. .- - . _ . _ __. _ _ . _ _ . - . _..- . . ~

hif. '

E .

-4 -

l i

Comments may also be communicated by telephone at (202) 395-3084.

a

_Tho NRC Clearance. officer'is Brenda Jo. Shelton, (301) 492-81?2.

. Dated-at Bethesda, Maryland, this -

day of scar 44 dA 1992. . Ji For;the-Nuclear. Regulatory Commission

,44 su?7 w.y v v .<

v George:H. Messenger, Acting Designated Senior Official-for Information Resources Management 7