ML19210B790
| ML19210B790 | |
| Person / Time | |
|---|---|
| Issue date: | 10/30/1979 |
| From: | Felton J NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Vakerics T O'CONNOR & HANNAN |
| Shared Package | |
| ML19210B791 | List: |
| References | |
| FOIA-79-362 SECY-79-234, SECY-79-234A, NUDOCS 7911120379 | |
| Download: ML19210B790 (3) | |
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UNITED STATES 8
NUCLEAR REGULATORY COMMISSION h
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- l gCT 3 01979 Thomas V. Vakerics, Esquire O'Connor & Hannan 1747 Pennsylvania Avenue, N.W.
Suite 600 IN RESPONSE REFER Washington, DC 20006 TO F0IA-79-362
Dear Mr. Vakerics:
This is in further response to your letter dated August 30, 1979 in which you requested, pursuant to the Freedom of Information Act, nine categories of documents.
The documents listed on the appendix are enclosed.
The document:
Proposed Revocation of Interim Enforcement Policy and Notice of Availability of Proposed Guideline for Nuclear Pharmacics Describing Activities that Require Registration as a Drug Establishment was originated by the Food and Drug Administration (FDA) and has been referred to the artment of Health, Education and Welfare for disclosure determination and direct response to you.
The document:
A draft undated memo regarding " Nuclear Pharmacies" by Vandy L. Miller, Chief, License Management Branch, Division of Fuel Cycle and Material Safety contains prelimipgy opinions and recommendations of the staff and has not been finalized. This information is being withheld from public disclosure pursuant to Exemption (5) of the freedom of Information Act (5 U.S.C. 552(b)(5)) and 10 CFR 9.5.(a)(5).
Pursuant to 10 CFR 9.9 of the Comm'ssion's regulations, it has been determined that the information withheld is exempt from production or disclosure, and that its production or disclosure is contrary to the public interest. The persons responsible for this denial are the undersigned and Mr. William J. Dircks, Director, Office of Nuclear Materials Safety and Safeguards.
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This denial may be appealed to the Commission's Executive Director for Operations within 30 days from the receipt of this letter. As provided in 10 CFR 9.11, any such appeal must be in writing, addressed to the Executive Director for Operations, U.S. fluclear Regulatory Commission, Washington, DC 20555, and should clearly state on the envelope and in the letter that it is an " Appeal from the Initial F0IA Decision."
Sincerely,
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J. M. Felton, Director Division of Rules and Records Office of Administration 700 --
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;,D FOIA-79-362 WOftfj,b4 APPENDIX A 1.
SECY-79-234 - COOPERATIVE RELATIONSHIPS WITH OTHER FEDERAL AGENCIES IN THE MEDICAL AREA, dated 3/30/79 2.
SECY-79-234A - COOPERATIVE RELATIONSHIPS WITH OTHER FEDERAL AGENCIES IN THE MEDICAL READ - SECOND QUARTERLY REPORT, dated 8/16/79 p-1317
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August 30, 1979 C. a ETLY oS e e-iS 70>
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Mr. Daniel J.
Donoghue EREEDOM OF INFORMATION i
Director Office of Administration ACT* REQUESI U.S. Nuclear Regulatory Commission gp-g.J f, L Washington, D.C.
20555
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Freedom of Information Act Request
Dear Mr. Donoghue:
Pursuant to the Freedom of Information Act, 5 U.S.C.
552, it is hereby requested that the NRC provide copies of the following documents to the undersigned:
1.
All documents in the possession of the NRC which refer to chemical grade and/or pharmaceutical grade Xenon-133 including documents containing any as
- gas, sessment of similar-ities and differences between chemical grade and pharmaceutical grade Xenon-133 and the appropriate uses of chemical grade and/or pharmaceutical grade Xenon-133.
2.
All documents which refer to a liaison agreement or understanding between the NRC and the Food and Drug Adminis-tration ("FDA") relating to the division of jurisdictional anu enforcement responsibilities between the NRC and the FDA in relation to the investigation or regulation of radiopharmaceu-ticals.
3.
All licenses issued by the NRC relating to the use of Xenon-133, including licences issued to Union Carbide, General Electric, New England Nuclear, and all federal facili-ties, including federal hospitals and the Oak Ridge facilities.
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All documents relating to communications received tw*"
the NRC concerning Xenon-133, including communications b
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+7 NRC licensees other than Nuclear Pharmacy, Inc.
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5.
All documents relating to the NRC investigation which resulted in a notice of violation sent by the NRC to Nuclear Pharmacy, Inc., dated August 17, 1979, including any documents which relate or refer to communications or complaints concerning the handling of Xenon-133 gas by Nuclear Pharmacy, Inc.
6.
All documents which relate to practices and pro-cedures of public and private hospitals and federal health care facilities in the United States in regard to the use of Xenon-133, their sources of Xenon-133 (whether chemical grade or pharmaceutical grade), and their authority and limitations as to the acquisition, processing and use of Xenon-133.
7.
All documents which relate to testing procedures for Xenon-133 which will demonstrate sterility, freedom from pyrogins, radionucleic purity and/or any other tests which may be required by the NRC or the FDA, or test procedures which are generally available to demonstrate whether Xenon-133 gas is of a pharmaceutical or chemical grade.
8.
All documents which relate to procedures which must be followed, including procedures required by the NRC and/or FDA, in order to render Xenon-133 safe for human use.
9.
All documents which contain or refer to statements that (a) Union Carbide Xenon-133 is not fit for human use and/or (b) that Xenon-133 obtained from Union Carbide which was pro-cessed by Nuclear Pharmacy, Inc., was not fit for human use after the Xenon-133 was processed by Nuclear Pharmacy, Inc.
The documents described above are believed to be publicly available and within the custody of the Office for Operations, Fuel Facility and Materials Safety Branch, Office of Inspection and Enforcement and within the custody of the Region III Office of the NRC.
Richard Bachman, an attorney on the NRC legal staff, should have general knowledge of the location of the requested documents.
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August 30, 1979 Page Three If any portion of this request is denied, it is further requested that a detailed statement of the reasons for with-holding any suen documents, including an index which describes the nature of the documents, be made available to the under-signed.
It is respectfully requested that this Freedom of Infor-mation Act request be expeditiously processed and that a response to this request be made available within ten working days of receipt of the request by the NRC."
Very tru
- yours,
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Thomas V. Vakerics TVV/cym nn?
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