ML20136E879

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Submits Comments on Proposed Rev to 10CFR35 & Reg Guide 10.8 Re Preparation of Applications for Medical Programs & Requests Addl Info for Review
ML20136E879
Person / Time
Issue date: 03/21/1984
From: Grace J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To: Cunningham R
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20136D915 List: ... further results
References
FRN-50FR30616, RTR-REGGD-10.008, RULE-PR-35 AA73-1, NUDOCS 8404050044
Download: ML20136E879 (2)


Text

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(g UN11TD STATES NUCLEAR REGULATORY COMMISSION g.e Q ,.

N ; r[,,

y WASHINGTON, D. C. 20555 ,

?, March 21, 1984 I

? . . . . .,/

s) j (('p Richard E. Cunningham, Director

.HEMORANDUM FOR:

Division of Fuel Cycle and Material Safety, NMSS

.FR0M: J. Nelson Grace, Director Division of Quality Assurance, Safeguards, and Inspection Programs,.IE

SUBJECT:

REQUEST FOR REVIEW 0F DRAFT 10 CFR PART 35 AND DRAFT REVISION OF REGULATORY GUIDE 10.8, GUIDE FOR THE PREPARATION OF APPLICATIONS FOR MEDICAL PROGRAMS

'We have reviewed the proposed revision for 10 CFR Part 35 and Regulatory

- Guide 10.8 and have the following comments for your consideration.

Draft Commission payer p.5, line 13 from top

... licensees will 3e free to modify their procedures without NRC review or approval ..." and Draft Commission Paper p.5, lines 21 and 28 from top.

" A licensee will be cited for... failure to follow technically valid procedures."

It- is apparent fram the above two statements that since modified procedures v~,

will.not be reviewed by license reviewers, they will have to be reviewed during

. inspections to show that they are technically valid and for the licensee to meet

/ compliance. This ans the inspectors would have to spend more time during

{ inspections. dan /co/} Q 'L/ ,xf p p gryfg,w

' Proposed Rule p.21, last sentence.

3 - Why more stringent license requirements? Are the regulations deficient?

Y ,nD tmq /1.f.,'mA w Atw .JCTpi-Enclosure 1, p.107-635.80, item (d)4cnf / gg, ,,gjagy/tw This statement is vague as to what type of trans assurance is required. emcg, Met ,,p.h'/ /r;M edd/equipment ported h drMgst and quality Proposed revision 2, Regulatory Guide 10.8, p.24.

N 7"#

What guidance is given to supervised inoividuals when authorized. individuals t

are on vacation, etc. on#M cadk wg f,6,w.

e Proposed revision 2, to Regulatory Guide 10.8, p.53.

Add item 8 to inventory on new sources to be.placed in the safe. ed'AD.

Proposed revision 2, to Regulatory Guide 10.8, p.75.

First paragraph, third sentence. tA

, fg g f 4 IE needs a justification for this requirement. I CONTACT: H. Karagiannis, IE 492-9655

R. E. Cunningham 2 We will be glad to answer any questions you may hav regarping our comments.

( W W J. Ne on Grace, Director Divi on of Quality Assurance, Safeguards, and Inspection Programs, IE 1

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