ML20211E080

Request for OMB Review & Supporting Statement Re NRC Form 473, Diagnostic Misadministration Rept. Estimated Respondent Burden Is 500 H

ML20211E080
Person / Time
Issue date:	02/13/1987
From:	Norry P NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
NUDOCS 8702240227
Download: ML20211E080 (6)

Text

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?_ ""~ _ Rea.uest for GMB Review D @ISIC"r

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v important Pead iristn.i tws teforw...ymtg im Do ret uw the vene SF 83 Send three cop,e., of the fum, the materrat to be rev.ewed. and tar to req.s st noth ao betutiw Order 1231 receu amt ao:,roval under pa,wrwo a -t! ree r n;nes of the sup;orting statement. to the Papcrv.ork Red sc! ion Act Answer all c,uestions in Part I ff 156 request is fm revu.w under LO Of fice of Information and Fegulator y Af f airs 122'J1. comp lete Part il and sign the regulatory certification. If this Office of Management and Budget request is for approval under the Paperwork Reduction Act and 5 CFR Attention: Docket Library, Room 3201 1320. skip Part II, compiete Part 111 and sign the paperwork certification Washmgton, DC 20503 PART l.-Cornplete This Part for All Requests.

2. Department / agency and Bureau /off.ce orig.nating req;est 2. Agencycode U.S. Nuclear Regulatory Commission 3 1 5 0

3. Name of person who can best answer questions regarding th> regist Telephone number Norman McElroy

<3013427-4108

4. Title of information conection or ruientaking NRC Form 473 - Diagnostic Misadministration Report

$. Legat auther,ty for mformation conection or rule (cite Unared Stsles Code, Pub!oc law. or Enecutive Order) 42 usc 2201(a) .or

6. Affccted pubhc(check allthatapply) 5 T Federat agencies or employees 1 O individuaisornousencias 3 0 rarms s M Non.profitinstitutions 2 O stateorlocatgovernments 4 T Businesses or other for-profit 7 I smasibusinessesororganizations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291

7. Peguistion identifier Number (RIN)

,___~_ _ , or, None assigned O

8. Type of submission (check one on each category) Type of review requested CIsssification Stage of development 10 Standard 1 O uaior i O Proposed or draft 2 O eending 2 Nonmajor 2 O Finatorintenmfinal.with pr orproposal 3 Emergency 3 0 Final or intenm final, without poor proposal 4 Statutory or judicial deadkne

9. CFR sxtion affected CFR

10. Does this regulation contain report ng or reccrdkeepmg requirements that require OMB approval under the Paperwork Reduction Act and 5 CFR 1320?

O ves O No

11. If a major rule,is there a regulatory impact analysis attached? I' Yes 2 O No if"No."did OMB waivt the ana'ysis?

3 0 ves 4 0 No C;rtific tion for Regulatory Submissions in sutsmitting this request for OMB review. the authorized regulatory contact and the program official certify that the requirements of E O.12291 and any applicable pohey directives have been comobec with.

Segnature of program official Date 8702240227 870213 PDR ORG EUSOMB PDR

1. gnaiu.c vi suu*umeu se);uidtury tuntact Date

12. (OMB use only)

Previous e4tions obsoiete g3 g3g standard Form 83 tRev. 9 83)

NSN 7540 00 634 4034 Prnce. bed by CMB 5 CFR 1320 and i O 1229t

f' ART fil.-Complete This Part Only if it3e pequest h for Approva: of a Collection of Intatmation UrWr the Paperwork Reduction Act and 5 CrH 1320 ~

n Elte I writr t noesm e,".ma dn Av.wuis i " Radiation ~eipossr'e hazards"~ ~~~

NRC Form 473 will be used by NRC medical licensees to report diagnostic misadmiristrations of radiopharmaceuticals as required by 10 CFR Part 35,

14. T ype of inforrnation collection (chec A only one)

Information collections not contained m rules I h Regular submission 2 O Emergency submission (certificatioriattached)

Information collections contained in rules 3 O Existing reguiation (no change proposed) e r,nai or intenm finai witnout pnor NPRM 7. Ente, date of e,pected or actuai rederai 4 Notice of proposed rulemaking(NPRM) A O Regular submission Register publication at this stage of rufemaking 5 0 rinai. Neau .as oreviously published B D cmergency submission (cert,ricat,on attached > (month dar rear >

15. Typa of review requested (check only one) 1 New collection 4 0 Reu..tatement of a previously approved collection for which approval 2 LJ Revision of a currently approved collection t.as optred .

3 0 Extension of the empiration date of a currently approved collection 5 0 Existing collectiorun use without an oMBcontrol number without any change in the substance or in the method of collection

16. Agency report form number (s)(include standard / optional form number (s)) 22. Purpose of snformation coflection (check as many as apply) 1 O Application for benefits NRC Form 473-2 E Program evaluation

17. Annualreportingordisclosure burden 3 O Generalpurposestatistics 1 Number of respondents . 600 4 @ Regulatory or comp!.ance 2 Number of responses per respondent- 1 5 0 erograr'n'pianningor rnanagement 3 Total annual responses (line 1 times hne 2) son s O Research 4 Hours per response 1 7 O Audit '

5 Total hours (I ne 3 times Irne 4) Rnn

18. Annual recordkeeping burden 23. Frequency of recordkeeping or reporting (check allthat apply) 1 Number of recordkeepers 1 Recorakeeping 2 Annua! hours per recordkeeper. Reporting 3 Tttil recordkeeping hours (hne 1 times line 2) 2 @ onoccasion 4 Recordkeeping retention penod years 3 0 weekiy

19. Tottlannual burden 4 O Monthly 500 1 Requested (hne 17-5 plus hne 18-3) . 5 0 ouartersy 2 in current oMB inventory 0 s O semi-annuaiiy 3 Difference (hne lless one2) 500 7 O Annually Esplanation of difference 8 O Biennially 4 Program change - +500 9 otner tdescnee):

5 Adjustment .

20. Curr;nt (most recent) oMB control number or comment number 24. Respondents' obligation to comply (check thestrongest ODhgation thatapphes)

Nnn, 1 O voluntary

21. Requested expiration date 2 O Required to obtain or retain a benefit

'l vears frnm annrnyal ria to 3 E3 Mandatory

25. Ara the respondents pnmarily educational agencies or institutions or is the pnmary purpose of the collection related to Federal education programs? Yes G No

26. Does the agency use sampling to select respondents or does the agency recommend or presenbe the use of sampling or statistical analysis by rsspondents? ,

Yes G No

27. Regulatory authority for the information collection 10 CFR 35_33 ;or rR  ; or,other (speerfy):

Paperwork Certification in submitting this request for oMB approval, the agency head, the senior official or an authonzed representative, certifies that the requirements of 5 CFR 1320. the Prkicy Act, statistical standards or directives, and any other appisCable information policy directives have been complied eth.

signature of program official Date s+gnitura of agency head, the senior official or an authonied representative Date Of eofkd n r nn /

O GPO r 1984 0 - 453-776

OMB SUPPORTING STATEMENT FOR NRC FORM 473, " DIAGNOSTIC MISADMINISTRATION REPORT" Description of the Information Collection The NRC collects information on diagnostic misadministrations to determine whether any changes in regulations might reduce their frequency.

A. JUSTIFICATION i

1. Need for the Collection of Information. This Information is needed to determine whether misadministrations are occurring that could be avoided or mitigated by changes in NRC regulations, or licensing and inspection procedures. Misadministrations cause unnecessary radiation dose to members of the public. '

) 2. Agency Use of Information. This information is reviewed and analyzed for trends by NRC's Office for Analysis and Evaluation of Operational Data. If a trend develops, the NRC will provide the analysis to its licensees for their information, and develop changes in its regulation of the medical use of byproduct material that will help to avoid future misadministrations.

3. Reduction of Burden Through Information Technology. The sporadic nature and extremely small frequency of misadministrations prohibits the efficient use of information technology to collect this information.

4. Effort to Identify Duplication. The Federal Information Locator i System was searched to determine NRC and other Federal Agency duplication. None was found.

5. Effort to Use Similar Information. The staff is not aware of any other organization that collects information regarding the improper administration of radiopharmaceuticals.

NRC FORM 473 2

6. Effort to Reduce Small Business Burden. Only 12% of affected ifcensees are likely to be classified as small businesses. However, their clinical facilities and operations are similar to those of large licensees and therefore no reduction appears feasible.

7. Consequences of Less Frequent Collection. The infonnation is collected shortly after the occurrence of an event. It could not be collected less frequently.

8 Circumstances Which Justify Variation From OMB Guidelines. The submission is needed within fifteen days to assure that, if there is a pub 1fc health and safety problem or generic implications, the agency can take prompt action.

9. Consultations Outside the NRC. No persons outside the NRC were consulted.

10. Confidentiality of Information. The NRC provides no pledge of confidentiality for this collection of information.

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11. Justification for Sensitive Questions. No sensitive information is requested.

12. Estimated Annualized Cost to the Federal Government. The collection of infonnation will require an average of I hour per report. The l staff estimates the NRC will receive 500 reports each year. At $60 per staff hour, the annual labor cost will be $30,000 (1 hr/ report x 500 reports /yr x $60/hr = $30,000).

13. Estimate of Burden.

a. There are 2500 affected licensees. Under current reporting regulations, roughly one-fifth of medical licensees submit a

, misadministration report in a given year. The NRC receives

! about 500 misadministration reports each year, and it takes l about one hour to complete each report. The total industry burden is therefore 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> each year (500 licensees / year x 1 report / licensee x 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> / report).

NRC FORM 473 3

b. Assuming a licensee has a misadministration event about every fifth year, it takes one hour to make a report, and the report is prepared by a professional who is paid $100 per hour, the estimated annual cost per licensee is $20.

c. The values used in these estimates are based on current reports and staff experience when formerly employed by licensees.

14. Reasons for Change in Burden. This is an initial submission and not a change.

15. Publication for Statistical Use. The Office for Analysis and Evaluation of Operational Data occasionally publishes summary papers on the reports.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Statistical methods are not used in the collection of information because there are so few misadministrations that sampling would not provide a complete picture of the causes of misadministrations.

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