ML20217P751

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First Partial Response to FOIA Request for Documents. Documents Listed in App A,Already Available in Pdr.Documents Listed in App B,Being Released in Entirety
ML20217P751
Person / Time
Issue date: 04/07/1998
From: Racquel Powell
NRC OFFICE OF ADMINISTRATION (ADM)
To: Jacqueline Thompson
AFFILIATION NOT ASSIGNED
Shared Package
ML20217P754 List:
References
FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100177
Download: ML20217P751 (5)
v • d • e


Text

NRC FORM 464 Part i U.S. NUCLEAR REGULATORY COMMISSION E'sPCytoc NuMeFR FOIA/PA 98-86

  1. [aso\ Ag)0' n RESPONSE TO FREEDOM OF 1

I a

S J INFORMATION ACT(FOIA)/ PRIVACY k '..**/ ACT (PA) REQUEST

RESPONSE

TYPE b- ^

REQUESTER DATE Justine Thompson IAPR 071998 PART l. -INFORMATION RELEASED (See checked boxes)

] No additional agency records subject to the request have been located.

] Requested records are available through another public distribution program. See Comments section.

r ' APPENDICES ~~

'J Agency records subject to the request that are identified in the listed appendices are already available for A public inspection and copying at the NRC Public Document Room.

APPENDICES ~

' I Agency records subject to the request that are identified in the listed appendices are being made available for

~

H public inspection and copying at the NRC Public Document Room.

Q EnciosMis information on how you may obtain access to and the charges for copying records located at the NRC Public Document Room 2120 L Street, NW, Wa'shington, DC.

M Agency records subject to the request are enclosed.

]- Records subject to the request that contain information originated by or of interest to another Federal agency have been referred to that agency (see comments section) for a disclosure determination and direct response to you.

Q We are continuing to process your request.

] This completes NRC's action on your request.

PART l.A - FEES

(-]- Fees cuoVNT * - ~ ~

[ ] You will be billed by NRC for the amount listed.

lf . ].. None. Minimum fee threshold not met.

I l]. You will receive a refund for the amount listed.

[_] Fees waived.

7 --

PART 1.8 -INFORMATION NOT LOCATED OR WITHHELD FROM DISCLOSURE

] No agency records subject to the request have been located.

IlJCertain information in the requested records is being withheld from disclosure pursuant to the exemptions described in and for the reasons stated in Part ll.

]- This determination may be appealed within 30 days by writing to the FOIA/PA Officer. U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 Clearly state on the envelope and in the letter that it is a "FOIA/PA Appeal."

PART l.C CCMMENTS (Use attached Comments continuation page if required) l FDyL 3

!MGiNOT f RLLDOM O IN MMION T AND PHr OF F ICL R RusselFA owen' L #'

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9804100177 980407 '

PDR FOIA THOMPSON 98-86 PDR NRC FORM 464 Part 1 (3-1998) PRINTED ON RECYCLED PAPER This form was designed using inFormg

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Re: FO!A 98-86 ' !

APPENDIX A .

RECORDS ALREADY AVAILABLE IN THE PDR l

l' ACCESSION  !

L fiCL DAIC NUMBER DESCRIPTION /PAGE COUNT I

-1, 11/30/88 . 8904190105 Letter from H. Cooper, TI.eragenics Corp, to N.

s j- McElroy, NRC, regarding Modifications to Title 10  ;

E Part 35.400, with attachments: 1) FDA 510K I approval letter, 2) Georgia sealed source  ;

registration,3) TheraSeed product literature,4) . {

l Package insert and Dose Rate Tabis, and 5) List of  !

Theragenics Management personnel. i

! i

2. 12/20/88 8911290100 Memorandum from William G. Mcdonald to Eric l S. Beckjord; subject: Petition for Rulemaking (PRM-35-7) Filed by Theragenics Corporation; j providing copy of petition for review; requesting  !

i determination that petition qualifies for fast-track j rulemaking. ; Note: previously in Central File; can

l. now be released. (1 page) l l
3. 02/22/89 8911290186 Memo from Denton, GPA to Beckjord, RES re:

j Proposed Amendment to 10 CFR 35.400: Adding i l Palladium-103 for interstitial Treatment of Cancer (PRM-35-7)(1 page)

j. i
4. 03/28/69 8904190078 Proposed rule 10 CFR 35, "Pd-103 for Interstitial  ;

Treatment of Cancer" (8 pages). i

5. 04/07/89 8906080176 Memo from Beckjord, RES to J.B. Breaux, forwards

, proposed amend to 10 CFR35 re: reducing burden  ;

on medical use licensees planning to use Pd-103 '

source for interstitial treatment of cancer (4 pages).

6. 04/17/89 8911290061 Proposed rule 10 CFR 35, "Pd-103 for interstitial Treatment of Cancer" (2 pages). ,
7. 05/08/89 8905150202 Ltr from O.W. Linton, American College of Radiology, providing comments supporting

[

I proposed rule 10 CFR 35 re: use of Pd-103 for interstitial treatment of cancer (1 page).

8. 8/25/89 8911290114 Memo from Denton, GPA to Beckjord, RES re:

providing final concurrence on PRM-35-7. (2 pages)

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9. 8/29/89 8911290118 Memo Norry, ADM to Beckjcvd, RF 4 re: Review of the Final Rule on Palladiur.i-103 for Interstitial Treatment of Cancer (1 page)
10. 09/26/89 8910180242 "Pd-103 for interstitial Treatment of Cancer,"

10CFR35 final rule, regulations amended to add Pd-103 as sealed source in seeds to list of  ;

brachytherapy sources permitted for use in  !

treatment of ct cer l7 pages).

11. 11/21/89 8911290148 Memo from Beckjord, REO to Mcdonald, ADM re:  !

Petition for Rulemaking (PRM-35-7) Filed by

{

Theragenics Corporation (1 page) l l

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I Re: FOIA 98-86 APPENDIX B RECORDS BEING RELEASED IN THElR ENTIRETY NQ DATE DESCRIPTION /PAGE COUNT

1. 11/30/88 Ltr. to McElroy, NRC from Cooper, Theragenics Corp, re: Modifications to Title 10, Part 35.400. NOTE: The letter from FDA and the Georgia sealed source registration is provided as it has comments written on it.

(11 pages)

2. 01/19/89 Comments from Donna-Beth Howe on 1/19/89 memo from Tse, RES to Various re: Draft Proposed Rule: Pallidium-103 for Brachytherapy.

(7 pages)

3. 01/23/89 Note to Tse, NRC from Baggett, NRC re: Draft Proposed Rule:

Palladium-103 for Brachytherapy (5 pages)

4. 01/23/89 Memo fron L. Bolling to A. Tse, subject: Draft Proposed Rulo.

Palladium-103 for Brachytherapy. (1 page)

5. Undated Memo, concurred in on 2/13/89, from E. Beckjord to V. Stello, subject:

Proposed Amendment to 10 CFR 35,.400: Adding Palladium 103 for Interstitial Treatment of Cancer (PRM-35-7). (15 pages)

6. 02/14/89 Memo from Beckjord, RES to Various re: Proposed Amendment to 10 CFR 35.400: Adding Palladium-103 for interstitial Treatment of Cancer (PRM-35-7); requesting office concurrence. (2 pages)
7. 03/23/89 Memo from Beckjord, RES to Stello, EDO re: Proposed Amendment to 10 CFR Part 35.400, Adding Palladium-103 For Interstitial Treatment of Cance.r (PRM-35-7) (6 pages) 8 04/06/89 54 FR 13892, Fe@ral Register notice for proposed rule (2 pages)
9. 04/'.0/89 Routing and Transmittal slip from A. Tse to K. Ruhlman, providing an advanced copy of the draft Regulatory Analysis associated with the proposed rule and a copy of the Federal Register notice. (1 page) '
10. 07/06/89 Memo from A. Tse to Various re: Review of Draft Final Amendment i Concerning Palladium-103 (PRM-35-7). (7 pages) l 11, 7/24/89 Memo from B. Shelton to D. Meyer, subject: Request for Comment / Concurrence on the Final Rule,10 CFR 35, Palladium-103 for

)

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Interstitital T*aatment of Cancer. (1 page)

12. 08/16/89 Marked up '/ersion of Memo from Be2jord, RES to Va,fous re: Request j Concunc; ice on Final Amendment ta 10 CFR 35.400 (11 pages) '
13. 08/21/89 Memo from Beckjord, RES to Various re: Request Cocurrence on Final Amendment to 10 CFR 35.400. (22 pages) i
14. 09/12/89 Memo from Bernero, NMSS to Beckjord, RES re: Request Concurrence on Final Amendment to 10 CFR 35.400. (2 pages) i
15. 09/19/89 Memo from Beckjord, RES to Taylor, EDO re: Final Amend aent to 10 '

CFR 35.400 Adding Palladium-103 for Interstitial Treatment of Cancer (PRM-35-7). (6 pages)

16. 10/05/89 Routing and transmittal slip from A. Tse to M. Lesar re: publication of a final amendment (PRM-35-7) (1 page)
17. 10/24/89 Note from A.Tse to several individuals providing a copy of the Federal Register notice for the final rule (54 FR 41819, October 12,1989).

(1 page)

18. 11/03/89 Note from A. Tse to Sharon Mott providing a copy of the Federal Register notice on Pd-103 source (1 page)
19. 11/03/89 Note from A. Tse to Herbert w. Mower, Sc.D., providing a copy of the Federal Register notice on Pd-103 source (1 page)
20. 11/03/89 Ltr from Bahadur, RES to Cooper, Theragenics Corporation, providing a copy of the Federal Register notice for the final amendment to 10 CFR 35.400 (54 FR 41819, October 12,1989). (2 pages)
21. 11/21/89 Ltr from Tse, NRC to Curran, AAPM re: Providing a copy of Federal Register notice,54 FR 41819, October 12,1989. (1 page)
22. Undated Draft: Theragenics Corporation; Receipt of Petition for Rulemaking. (5 pages)
23. 9/29/95 Part 35 - Statements of Consideration, Palladium-103 for Interstittial Treatment of Cancer. (3 pages) 9 9

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