ML20137R118
Text
~
> &?1H pno
- g,p n f.'..
iv o.-
ganton UNITED STATES
- ' ' 'o, , NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20555 p
MAY ? 01982 MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards TilRU: Richard E. Cunningham, Director h-Division of Fuel Cycle and Materi&T' Safety Vandy L. Miller, Chief l' 7/6/8" Material Licensing Branch Division of Fuel Cycle and Material Safety FROM: William J. Walker, Jr., Section Leader Material Licensing Branch Division of Fuel Cycle and Material Safety
SUBJECT:
TASKNO.(PSB): 810892 Enclosed is Revision No. 2 to the subject Task Work sheet. This revision adjusts the date for sending the proposed rule to your office. The original estimate called for forwarding the package to the Commission in June, a highly speculative target date when the task force was first constituted in October 1981. A significant expansion in scope of the task force's original assignments (e.g., integration of MIS concepts and development of two companion regulatory guides), new regulatory require-ments, (e.g. regulatory flexibility) and the recent inclusion of Regional representatives on the task force have caused delays in completing initial phases of the task force's work.
By copy of this memorandum Revision No. 2 to the Task Work sheet is provided to other interested parties.
l/ .' '
/ .x _
William J. 1 r, Jr., Aection Leader Material Lidensing Branch' Division of Fuel Cycle and Material Safety
Enclosures:
- 1. Task Work form
- 2. Schedule Revision #1
- 3. Schedule Revision #2 850923o403 85o906 PDR
@"soNao616
P I
, . ' . ' MEDICAL GENERAL LICEN"SE .
- A / .fjESICAL AND ACADEMIC SECTION TASK WORK g fgf3 Division of Fuel Cycle and Material Safety PPSAS No. : 1322E Task No. (PSB):810892 Date of Task: 8/15/81 Assigned Responsibility _: W.J. Walker, Section Leader NMSS-15 (Medical and Academic Licensing)
Level of Effort: Staff Weeks RESS-10 (74052) Task Force
$ E. Podolak (RESS)
D. Bozik (RESS)
Originated By: ThereisaneedtostreamlinetheprocessoE*1N8N8)(NN materials' users who's radiation safety programs are generically similar. The medical nuclear medicine license is of this type.
Description:
Qualified medical licensees would be authorized nuclear medicine groups I, II and III (10 CFR 35.100) under a general license.
This represents a much broader use of a general license than in the past.
Product (s): (1) Staff paper to Commission for policy considerations. -
(2) New, streamlined, license procedure.
Other Organization Inputs Required: RES, Sandia Corporation (Contractor)
Concurrences Required: SP, ELD, IE, RES, OPE Schedule with Major Milestones: ,
Beginning Date: ASAP First Draft: See attached Time / Schedule Estimates Second Draft:
5~ Final Draft: --
Final:
-Resource Implications: Resources to support this effort are not included in the current budget. They are being reprogramed by NMSS and RESS because it is felt that commutting resources at this time will make materials licensing more efficient in the future. Involvement of the medical licensing'section leader will cause some minor sli pages in medical licensing.
N l lDivisionDirectorSignature 9/
~ . l
- I[
. Original Schedule Time / Schedule Estimates for Medical General Licensing Completion 1981-82 October 30 Conduct regulatory analysis:
- 1. Value-impact statement
- 2. Small Business impact analysis
- 3. Paperwork reduction analysis
- 4. Write proposed changes to 10 CFR 35 IAW Periodic and systematic review fa regulations January 30 Write proposed rule and commission paper Write Safety Analysis-comparing level of safety from general. licensing to specific licensing
- 1. Get detail from i and E on types and frequences of non compliance -
- 2. Frequency of items in deficiency letters .
April 30 Obtain:
- 1. Agreement states comments
- 2. Paperwork reduction clearance
- 3. Rewrites as necessary
- 4. Medical Advisory Comittee Review
- 5. Meeting with Executive Committee-SNM June 4 Commission action-for publication in Federal Register 3 Months Comment period and OMB clearance 3 Months Analysis of comments and rewrites 1 Month Concurrances(noagreementstates) 1 Month Commission Action
/
l' l" Revision No. 1 SCHEDULE ESTIMATES FOR MEDICAL LICEt:SIf;G TAS!; FORCE Due to a reordering of priorities within the time frame previously submitted, the following revised schedule will be followed.
October 30 Regulatory Analysis Input
- 1. Preliminary Value/ Impact completed
- 2. Small business impact certification completed
- 3. Paperwork Reduction Analysis ongoing
- 4. Draf t of proposed changes to 10 CFR 35
. in accordance with periodic and systematic review of regulations under revision January 30 Proposed rule and Comission paper 3rd staff draf t Review of items of licensee non-compliance from IE completed Review of licensee deficiency letters completed Meeting with Executive Comittee of completed Society of Huclear Medicine January 26 M:!rch 19 Proposed rule and Commission paper to major flRC of fices for office concurrence Copies to ACMUI and Agreement States April 23 Comments on proposed rule and Commission paper due to Task Force from:
- 1. f1RC Offices
- 2. Agreement States May 21 Completion of resolution of conments and rewrites as necessary June 4- Proposed rule to Comission for publication in the Federal Register Paperwork Reduction Clearance prepared to go forward af ter Comission approval 3 months Coment period and OM3 clearance 3 months Analysis of coments and rewrites 1 month Concurrences (no Agreement States) 1 month Commission action 01/26/82
I'
' '- R2 vision No. 2
-;.i SCHEDULE ESTIMATES FOR MEDICAL LICENSING TASK FORCE Due to a reordering of priorities within the time frame previously submitted, the following revised schedule will be followed.
October 30 Regulatory Analysis Input
- 1. Final Value/ Impact completed
- 2. Small business impact certification completed
- 3. Paperwork Reduction Analysis completed
- 4. Draft of proposed changes to 10 CFR 35 in accordance with periodic and systematic review of regulations completed January 30 Proposed Rule and Comission paper completed Review of items of licensee non-compliance from IE completed Review of licensee deficiency letters completed Meeting with Executive Comittee of Society of Nuclear Medicine completed May 7 Proposed rule and Comission paper to major NRC offices for office concurrence completed Copies to ACMUI and Agreement States completed June 9 Comments on proposed rule and Comission paper due to Task Force from:
- 1. NRC Office
- 2. Agreement States June 23 Completion of resolution of comments and rewrites as necessary June 30 Proposed rule to the Director of NMSS July Proposed rule to the ED0 August Proposed rule to the Comission Paperwork Reduction Clearance prepared to go forward after Comission approval 3 months Coment period and OMB clearance 2 months Analysis of coments and rewrites 1 month Concurrences (noAgreementStates) 1 month Commission action 5/18/82
Revision No. 3
. SCHEDULE ESTIMATES FOR MEDICAL LICENSING TASK FORCE October 30 Regulatory Analysis Input
- 1. Final Value/ Impact completed
- 2. Small business impact certification completed
- 3. Paperwork reduction analysis completed
- 4. Draft of proposed changes to 10 CFR 35 in accordance with periodic and systematic review of regulations completed January 30 Proposed rule and Commission paper completed Review of items of licensee non-ccmpliance from IE completed Review of licensee deficiency letters completed Meeting with Executive Committee of Society of Nuclear Medicine completed May 7 Proposed rule and Commission paper to major NRC offices for office concurrence completed Copies to ACMUI and Agreement States completed June 9 Comments on proposed rule and Commission paper to be received from Agreement States completed
- August 30 Comments on proposed rule and Commission paper to be received from NRC Offices
- September 17 Completion of resolution of comments and rewrites as necessary Proposed rule to the Director of NMSS
- September 30 Proposed rule to the ED0
- 0ctober 31 Proposed rule to the Commission Paperwork Reduction Clearance prepared to go forward after Commission approval 3 months Comment period and OMB clearance 2 months Analysis of comments and rewrites 1 month Concurrences (no Agreement States) 1 month Commission action
- Revision No. 3 date 8/26/82
~ - . n.
Revised Task Work PurpnFe Cf*.Cubmission: N;w Task X Revised Task Date: August 26, 1982 Task itle: Proposed Revision of 10 CFR Part 35 on Human Task #: (PSB): 810892 Uses of Byproduct Material Task 3escriction: PPSAS #332134 Modify regulation of the medical use of byproduct material. The task will involve two-steps: (1) revise the regulations,10 CFR Part 35, to provide a single source of the requirements specifically related to human use of byproduct materials, and (2) revise the medical license review process. The latter step would allow use of an automated management information system (MIS).
Project Manager:
(Name/Of fice Symbol / Phone) William J. Walker, Jr., FCML, 74052 Product (s): 1) Staff paper to Commission for policy considerations.
- 2) New, streamlines, license procedure.
Other Organization Inputs Recuired: RES Concurrences Required: SP, ELD, IE, ADM, Regional Administrators Sch:dule:
Milestone Date .
See Attached Time / Schedule Estimates Resot ce Implications: (Provide for duration of Task by FY)
Re:uired Resources: FY8 : SY, $K; FY8 : SY, $K; FY8 : SY, $K l Bu:geted Resources: FY8[: SY, SK;FY8[: SY, $K;FY8[: SY, SK i i
Scarce (s) of Unbudgeted Funds (If Necessary): Resources to support this effort are not included in the current budget. They are being reprogramed by NMSS and RES because it is Felt that the committing resources at this time will make materials licensing more efficient 1 Ir:act(s) of Reprogranning (If Necessary): in the future. Involvement of the Medical I Licensing Section Leader will cause some minor slippages in medical licensing.
sd e Fpprc . al : - .- .
l Division Director NMSS Director Date: . Date:
Enclosure 1
$RT:.3b Ci.HERAFFECTEDPART(5); None d!M
.EDEPAL REGISTER CITATION: Not yet published
SUBJECT:
Medical Licenses for Human Use of Byproduct Material
SUMMARY
- Description. The proposed rule would completely revise Part
- 35. This part contains the requirements and procedures applicable to a physician or medical institution that seeks to obtain a -
license authorizing the human use of byproduct material. The '
proposed rule would simplify the medical licensing process by
. adopting a " performance standard" approach to medical licensing.
The proposed rule would set out all the requirements a Ikensee must meet yet allow tl.e licensee flexibility in meeting the requi rements. The proposed rule would be consistent with ,.
regulatory reform objectives while maintaining .the current ,, f level of protection to the health and safety of the medical worker. and the gensral public.
Objective. To simplify the medical licensing process and recute the administrative burden on the licensee and the NRC by (1) including all the requirements a medical licensee must meet in the regulations; (2) eliminatino or modifying administrative requirements not essential to safety; {5)' simplifying the '
application form which, together with an automated licensing system, will create a more efficient licensing process; and (4) reducing the paperwork burden for the licensee and the NRC.
Background. The medical use of byproduct material has increased substantially over the past 30 years in terms cf the number and types of procedures performed. To keep pace with radiation safety in a rapidly changing field, many requirements:were imposed as license conditions or implied in regulatory guides.
In addition, current practices require that each new and renewal application be complete without reference to any previous submittal. Over the past few years, the practice of nuclear medicine has become more sophisticated and radiation # '
safety methodology and procedures have become more uniform.
This permits NRC to propose simplifying the licensing process by codifying all requirements into a simple set of requirements contained in the proposed r,egulation and simplify the license
- application form to eliminate a detailed explanation of the procedures involved. An earlier rule on which the NRC was considering action that would clarify the responsibiliti.es of .
various echelons of nuclear medicine personnel has been ' incorporated into this proposed revision of Part 35'.
Legal Basis. 42 U.S.C. "2Til ,~ 2201', 2212, 2233.
4 e6
Cornission action on the proposbd rule is scheduled TI ETAILE:
' for.hn 1382. f7uG'g2,. .
C0!iTACT: Willf am 'J. Walker Nuclear Material Safety and Safeguards (301) 427-4232 b
C
. ,= e
. g"
. . . . ~~~. -
- ~ ~. ,,
4 . ,
e som e
e t
MO
- 60 .
. 9
- 0 g
- , M bqs
. t O
- ee
- W
.4
11/24/81 MEDICAL LICENSING TASK FORCE (RevisiontoPart35)
Telephone Organization Room Number _ ,
William J. Walker 42-74052 FCML 360 Willste Task Force Leader John R. Cook 42-74240 FCMC 418 Willste ,
Robert L. O'Connell 42-74211 FCTA 372 Willste Deborah Bozik 42-74566 RES 1050 Willste Edward M. Podolak 42-74561 RES 1044 Willste Norman McElroy 44-35966 RES 133 Nich Lane Francis X. (Chip) Cameron 44-35981 RES 367 Nich Lane Alfred W. Grella 49'-28119 IE 448A East-West Thomas F. Dorian -
49-28696 ELD 9704 NMBB John F. Klucsik 49-27688 ELD 9711 NMBB Ellen Kraus 42-74135 FC 590 Willste Technical Editor 966-2008 Maureen Moriarty 42-74214 FCML 395 Willste Marylou Blasizek (503) 229-5797 Oregon (SP)
Carol Connel (404)894-5795 Georgia (SP)
Mark Elliott 342-6700 IEAL*
Brad Wells 342-6700 IEAL Mail Stops FC -
396-SS
- International Energy Associates LtG 600 New Hampshire Avenue, N.W.
RES -
1130-SS Suite 600 Washington, D.C. 20037 IE -
'359-E/W ELD -
9604 NMBB
_