ML20217Q237
| ML20217Q237 | |
| Person / Time | |
|---|---|
| Issue date: | 09/12/1989 |
| From: | Bernero R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100351 | |
| Download: ML20217Q237 (2) | |
Text
_ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ,
Morris o
Bahadur
- / onc 'o, UNITED STATES Telford 8' '% NUCLEAR REGULATORY COMMISSION 4sh 5 E WASHINGTON, O. C. 20555 file k-
, ;;: ' ! %9 pt p , I 9.E9 MEM0PANDIN FOR: Eric S. Reckjord, Director Office of Nuclear Regulatory Research FROM: Robert M. Bernero, Director Office of Nuclear Materials Safety dnd Safeguards
SUBJECT:
REQUEST CONCURRENCE ON FINAL AMENDMENT TO 10 CFR 35.400 The Office of Nuclear Materials Safety and Safeguards concurs with the final rulemaking package in response to the petition for rulemaking (PRM-35-7), if Enclosure B, paragraph 2 is moaifiea to state that "The Food and Drug Administration pent.itted marketing of this Class II med cal device under Section 510(k) of the Fehral Food, Drug and Cosmetic Act as amended."
If you have any questions, please contact Donna-Beth Howe at Ext-20636.
},' L w Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguaras
&q:
9804100351 980407 PDR FOIA I Il THOMPSON 98-86 PDR ;
~
l u
ay? : t...
MEMORANDUM FOR: .Eric 5. Beckjora, Director Office of Nuclear Regulatory Research FROM:
Robert M. Bernero, Director Office of Nuclear Materials Safety and Safeguards
SUBJECT:
REQUEST CONCURRENCE ON FINAL AMENDMENT TO 10 CFR The Office of Nuclear Materials Safety and Safeguards concurs with the final rulemaking package in response to the petition for rulemaking (PRM-35-7), if Enclosure B, paragraph 2 is modified to state that "The Food and Drug Admini permittea marketing of this Class II medical device under Section 510(k) of the Federal Fooo, Drug and Cosmetic Act as amended."
If you have any questions, please contact Donna-Beth Howe at Ext-20636.
geti ,ud
- WPA Robert N. Bernero, Of rector Office of Nuclear Material Safety and Safeguards '
DISTRIBUTION NMSS-89C0467 w/o incoming DBHowe IMAB R/F hMSS R/F NMSS Dir. Off. R/F IMNS Central Files JEGlenn NM-Elroy NRC File Center CJenkins GSjoblem MLamastra CEstep RECunningham SBaggett JFunches D/ Sh D/NMSS
- See Previous Concurrence Motto RHBernero 9/g/89 09// 2./89
- 0FC:IMAB *:IMAB *
":IMAB *:IMAB
...._____....w........___ ...........:_IMAB :DD/IMN5*:D/IMN NAME:DBHowe:ht:ga SLBag ____..____.________......._____.4.*.____
................________gett:NMcElroy:MLamastra:JEGlenn:GSjoblom:RECunningham DATE:09/06/89 :09/06/89:_.......________...________...__.......____ ....____
09/07/89: 09/06/89 :09/06/89 :09/09/89:09/09/89 OFFICIAL RECORD COPY a
i