ML20217P751
| 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) | |
Text
NRC FORM 464 Part i U.S. NUCLEAR REGULATORY COMMISSION
'sPCytoc NuMeFR E
FOIA/PA 98-86
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RESPONSE TO FREEDOM OF a
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INFORMATION ACT(FOIA)/ PRIVACY k
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ACT (PA) REQUEST TYPE b-
RESPONSE
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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 ~~
Agency records subject to the request that are identified in the listed appendices are already available for
'J A
public inspection and copying at the NRC Public Document Room.
APPENDICES ~
Agency records subject to the request that are identified in the listed appendices are being made available for I
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.
f ] None. Minimum fee threshold not met.
l...
I l]. You will receive a refund for the amount listed.[_] Fees waived.
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PART 1.8 -INFORMATION NOT LOCATED OR WITHHELD FROM DISCLOSURE
] No agency records subject to the request have been located.
Il Certain information in the requested records is being withheld from disclosure pursuant to the exemptions described in and for J
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
9804100177 980407
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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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- FO!A 98-86 '
1 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).
{
Package insert and Dose Rate Tabis, and 5) List of l
Theragenics Management personnel.
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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
[
proposed rule 10 CFR 35 re: use of Pd-103 for I
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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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 r
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e e
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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
)
l i
i e
t 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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