ML20198B231
| ML20198B231 | |
| Person / Time | |
|---|---|
| Issue date: | 05/15/1986 |
| From: | Norry P NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | |
| References | |
| OMB-3150-0045, OMB-3150-45, NUDOCS 8605210573 | |
| Download: ML20198B231 (7) | |
Text
-
- PM
- -- . W
"" 0"MN
* 8 3 Request for 0MB g Review 4M/ ,,/g 5"'
tae , seme.t iss33 g, imp rtznt Send three copies of this form, the material to be reviewed, and for Read instructions before comp'eting form. Do not use the same SF 83 t3 rIquest both an Esecutae Order 12291 review and approval under paperwork--three copies of the supporting statement, to; -
the Papstwork Reduct cn Act. Office of information and Regulatory Aff airs ,
Answ2r all cuestions in Part 1. If this request is for review under E.O. Office of Management and Budget 12291, complete Part it and sign the regulatory certification. If this Attention: Docket Library Room 3201 recurst is for approval under the Paperwork Reduction Act and 5 .;FR Washrngton, DC 20503 1320. ship Part 11. comp ete Part lli and sign the paperwork certific stion.
PART l.-Complete This Part for All Requests. __
- 2. Agency code
- 1. Department / agency and 8steau.rof fice originating request U.S. Nuclear Regulatory Commission 3 1 5 0
~~
Telepnone numoer
- 3. Name of person ano tan best answer questions regarding this request Norman McElrov ( 1m ) 4?7_ainn _ _
4TTitle af information collection or rulemaking Medical License Occupational ALARA Program S. Ltgat tutnonty for enformatson collection ot rule (crie United States Coce. Pubhc law, or becutive Orcer) 42 use J201(o) ..,
- 6. Aff1ctId public(checa attthatapply) $ Q Federaiagencies or employees Farms 6 O Non profitinstitutions 1 individuals or households 3 4 O Businesses or other for profit 7 O smaii busmesses or organizations 2 O stateorioca: governments PART ll.-Complete This Part Only if the Request is for O*18 Review Under Executive Order 12291 __
- 7. Regulition identifier Number (RIN)
~~
_, __ _ . or. None assigned O ~
Type of review requested S. Type cf submissson (check one on each caregory)
CI:ssification Stage of development 1 O standard proposed or draft 2 O eending 1 O uajor 1 rinat or interim f.nai. witn prior proposai 3 O Emergency 2 O nonma,or 2 3 0 renai or intenm finai witnout enor proposai 4 0 statutory oriudiciaideadiin. -
- 9. CFR section affected CFR . . _ .
- 10. Does tnis regulation contain reporting or recordheeping requirements that require OMB approval under the paperwork Reduction Act . . Yes O N.-
and 5 CFR 1320? . . . . ..
1 O ves 2 O N.,
- 11. If a maior ruie, es there a retulatory impact analysis attached? . .
if"No.** did oMB waive the analysis? .
- 3 0 ves 4 O N.:
C2rtificrtion for Regulatory Submissions in submitting this request for oMB eeview, the autnonzed regulatory contact and the progeam official certify that the requirements of E o.12291 and policy directeves have been complied with. ~~
Date Signtturs of program official s.gniturs of autnonzed regutatory contact Date
- 12. (OMB use anly) smia.,a r.,. s 3 e. 4 :
n ie . eaa.o, s e ..ce . .. a ew .. - *. . " ~
NsN 75400 6344034 8605210573 860515 s cra i3:o,-e r o ; r.,
- . b PART lit.-Complete This Part Cnly if th: Rsqu:st is f:r Apprevtlcf a Cill:cthn of Information Under the Paperwork Reduction Act ar.d 5 CFR 1320.
- 13. Abstract-Desenne needs uses and af fected public in 50 words or less
" Radiation safety, radioactive materials" Applicants for and holders of a specific medical Ticense for human use of byproduct material are requested to establish and submit a formal program for maintaining occupational esposure as low as reasonably achievable (ALARA).
1* Type of information collection (check only one) information coffectlans not contained in rules 2 O Emergency submission (certificationattached) l h Regular submission Informatlan coMections containedin rules 7. cater eate of e.gected or actuai rederai s renar or intenm finai without prior NPRM 3 O taisting reguistion (no change ,<ogosed) Register puniscation at this stage of rutemakir g AO Regutarsubmission 4 O Notice of proposed rutemaking(NPRM) (maath. car. rear):
B O Emergency submissica ccert,ricat,on artsched>
5 rinal.NPRM was previously pubiished
- 15. Type of review requested (chec& only one) Reinstatement of a previousiy approved coiiection for which appro,ai 4
10 Ne.conection has espired 2 Revision of a currently approved collection 5 O taisting collection in use without an OMB control nurnber 3 @ titension of the empieation date of a currently approved coIIection without any change in the sutstance or in the method of collection
- 22. Purpose of informatnon col\ection (chech as enany as apply)
- 16. Agency report form number (s)(int!ude standard /optionaltorm number (s)) -
1 O Appiicationforbenefits Hone. 2 O Programevaluation 3 General purpose statistics
- 17. Annual reporting or disclosure burden 700 4 L Regulatory or compliance 1 fiumber of respondents . . . .
I 5 O Programplanningorenanagement 2 Number of responses per respondent .
200 s O Research 3 Total annual responses (line 1 times tene 2) .
4 7 O Audit 4 Hours per response . . . . . . .
800 5 Total hours (fine 3 times fine c 23. Frequency of recordkeeping or reporting (check allthatapply)
- 13. Annualrecordkeepingbutden
- .= 1 O Recordkeeping 1 Number of recordkeepers . . . .
Reportlns 2 Annual hours per recordkeeper. . . .
2 O onoccasion 3 Titat recordkeeping hours (Ane 2 times fine 2) .
years 3 O weekty 4 R'cordkeeping retention period 4 O Montnry
- 19. Total annual burden 000 $ Quarterty 1 Requested (lune 17 5 plus line 18 3) . .
6 0 semi-annuairy 809 2 tn current oM8 inventory . . . .
n 7 O Annuaitr 3 Difference (#ine J less fine 2) . . . . S Biennially Esplanation aldifference 9 @ Other(describe): One-the m y g;=,+
4 Program change . . . . .
5 Adjustrnent . 24. Respondents
- ontigation to compty (chech the strongest o6hgatiorr that atytc.
- 20. Current (most recent) OMS controi number or comment number votuntary 1
3150-0045 2 @ Required to obtain or retain a benefit
- 21. R; quested espiration date
- 3 0 Mandatory 3 years from approval date OvesGu
- 25. Are the respondents pnmarify educational agencies or institutens or is the pnmary purpose of the c
- 26. Does the agency use sampling to select respondents ... .
or does the. agency
. . . . . . . recommend. . . . . ..OvesGev or prescribe the w by rzspondentst . . . . .
- 27. R;gulatory authority for the information collection _ :or.other(specory):
20 1(cl :or rR 10 crR P.: perwork Certification f 5 CFR 1320. t' in submitting this request for oMB approval, the agency head, the senior of t cial or an authorized representativ *-
Pavacy Act. statistical standards or directives, and any other appi. cable inforrnation policy directives Cate have been comp S gnitute of progeam otticial .
Date S.gnitu e r of agency rseao. tne senior ott.ciai ur an agnori:eo representative
-U O nf r r +v_. ,
SUPPORTING STATEMENT FOR MEDICAL LICENSE OCCUPATIONAL ALARA PROGRAM 10 CFR SECTION 20.1(c)
(REGULATORY GUIDE 10.8, SECTION 1.4 & APPENDIX 0)
Justification Need for the Information Collection 4
The principle of maintaining occupational exposures (as well as public exposures) "as low as is reasonably achievable" ( ALARA) is an extension of an original recommendation of the National Committee on Radiation Protection (now the National Council on Radiation Protection and Measurements (NCRP))
in its 1949 report. In this early report, the NCRP introduced the philosophy of adopting the conservative assumption that any radiation exposure may carry some risk and recommended that radiation exposure be kept at a level "as low as practicable" (currently referred to as "ALARA") below the recommended maximum permissible dose (MPD) equivalent.
. Since the inception of Federal programs for licensing and regulating radioactive byproducts of atomic (nuclear) energy, regulations have been j written and guidance provided by Federal agencies with the aim of complying with these recommendations of independent scientific and professional organizations. In the licensing of medical institutions, NRC staff practice has been to review applications to ensure that reasonable radiation safety facilities, equipment, and procedures would be provided to maintain exposures to employees and the public at the lowest practicable levels consistent with the provision of good medical care.
Despite the history of independent recommendations and regulatory provisions for maintaining exposures ALARA and the initiatives of most industrial, medical, and academic licensee institutions in maintaining average employee exposures well below regulatory limits, NRC inspections and professional i reports in the literature have indicated that, in many cases, exposures could be further reduced by reasonable efforts and the adoption of good radiation safety practices. Further, for both private and university-affiliated medical institutions, an adequate radiation safety program can be shown to reduce costs and improve the effectiveness of medical and research programs, in addition to maintaining radiation exposures ALARA.
l NRC believes that application of the ALARA concept is an essential element in programs to protect the public health and safety. NRC regulations (10 CFR Section 20.1(c)) currently provide that licensees should make every
- reasonable effort to maintain radiation exposures, and releases of radio-active materials in effluents to unrestricted areas, as low as reasonably 1 achievable.
In order for NRC to be able to judge the adequacy of the practices that licensees intend to follow for maintaining occupational radiation exposures ALARA, it is necessary that each medical licensee establish and submit a formal program to the Commission for review. The elements of such a plan are contained in any good institutional health physics program.
o NRC is in the process of making ALARA requirements more specific in a revision to 10 CFR Part 20 that is currently underway. This is a major rulemaking to make the regulation conforn to present-day cancepts in radiation protection based on the recommendations of scientific bodies such as the International Commission on Radiological Protection (ICRP).
In the interim, until this rulemaking can be completed, NRC has requested all medical licensees to submit ALARA programs to NRC for review in order to assure that adequate measures are being taken to protect the health and safety of medical workers and the public. Medical workers constitute the single largest occupational aroup that NRC regulates. These programs are submitted in conjunction with licensee requests for significant licensing actions, such as new or renewal applications or reauests for amendments.
Most medical licensees have already submitted their programs under this one-time requirement. Thus the annual burden for the industry is expected to be less in future years.
For assistance to licensees in establishing a program, NRC has promulgated, in Appendix 0 of Regulatory Guide 10.8, a model ALARA progran that NPC finds acceptable and that has been reviewed by several NRC consultants, a member of NRC's Advisory Committee on the Medical Uses of Isotopes, and several members of the Society of Nuclear Pedecine. Licensees may choose to simply adopt the model program without change or may propose an alternative program.
Practical Utility of the Information Collection The NRC staff reviews ALARA programs which are submitted by licensees to ensure that reasonable radiation safety facilities, equipment, and procedures would be provided to maintain exposures to employees and the public at the lowest practicable levels consistent with the provision of good medical care.
lise of Imoroved Information Manaaement Technology There is no legal impediment to the use of improved information management technology by licensees and applicants.
Efforts to Avoid Duplication The Federal Information Locator System was searched to determine NRC and other Federal agency duplication. No duplication was found.
I l
Efforts to Minimize Burden for SmalT Businesses The model ALARA program promulgated by NRC should be of material assistance to small entities such as individual-physicians who would be able to simply sign and send in the model program without the need to create a new " custom" program.
Consequences of Less Frecuent Collection This information is only submitted once with an application for a license.
Once the licensee has submitted an acceptable program, no further submission is required unless changes occur.
Circumstances Which Justify Variation from OMB Guidelines There is no variation from OMB guidelines.
Consultations Outside the Acency There have been no consultations outside the agency since the previous clearance of this information collection requirement.
Assurance of Confidentiality None.
Sensitive Ouestions None.
Publication for Statistical Use Hone l
Estimate of Compliance Burden
- a. Number and Type of Respondents This information collection requirement affects approximately 2,000 medical licensees. Approximately 200 respondents are expected to submit ALARA programs for review annually.
- b. Record Retention Period The ALARA program should be maintained for the duration of the licensed activity. This retention period is necessary so that NRC can ensure tha,t all medical licensees have a formal commitment to the ALARA philosophy and a formal program for ensuring that personnel exposures are maintained ALARA.
- c. Copies Reouired Two copies of the program are required to be submitted.
- d. Estimated Hours Reouired to Respond to the Information Reouirement The average burden for preparation and submission of each program is estimated to be 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />. A total of approximately 200 programs are expected to be submitted annually. Thus, the total resulting burden for all licensees will be 800 hours0.00926 days <br />0.222 hours <br />0.00132 weeks <br />3.044e-4 months <br />. Since the program was established, a large percentage of affected licensees have submitted their programs under this one-time requirement. Thus, the annual number of respondents is expected to be less in future years. In addition, more widespread adoption of NRC's model ALARA program will result in a decrease in the per licensee and total burden,
- e. Estimated Cost to Respond The annual cost to each respondent to comply with this requirenent is estimated to be $140. The total annual cost to all affected licensees is estimated to be $28,000.
- f. Source of Burden Data and Method of Estimatina Burden This data is based on informal consultations by the staff with a small number of typical licensees and analysis of actual submissions received by NRC.
Estimate of Cost to the Federal Government Annual Cost - NRC Staff Review (Professional effort - 16 min / form 9 $60/hr) = $3,150 Annual Cost - Clerical Processing (Clerical effort - 10 min / form 0 $30/hr) =$ 999 Annual Administrative Costs See OMB Clearance (Postage, handling, envelopes, etc.) = $ No. 3150-0041 Annual Cost for Record Holdings (0.25 cu. f t x $209/cu. f t.) =$ 52 Annual Printing Costs =$ 180 Annual Cost for Storage of Forms in NRC Supply
($2.10 per 1,000) =$ 2
- Annual ADP Cost =$ l Total Annual Cost = $4,383 i
l l
l l
i b
_ _ . _ _._ _ - _ . _ ... - _. . ____ _ _ _.