ML20138J350

Staff Requirements Memo Advising Commission Has Not Objected to Renewal of MOU Between NRC & Fda

ML20138J350
Person / Time
Issue date:	01/29/1997
From:	Hoyle J NRC OFFICE OF THE SECRETARY (SECY)
To:	Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
References
REF-10CFR9.7 NUDOCS 9702070086
Download: ML20138J350 (2)

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• • • • • • • • • • • eoos UNITED STATES jf NUCLEAR REGULATORY COMMISSipN RELEASED TOTHE PDR l

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January 29, 1997 3

OFilCE OF THE SECRETARY I

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MEMORANDUM TO:

Hugh L. Thompson,'Jr.

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Act g.xe ut Director for Operations l

FROM:

Jo C.

oyte, Secretary

SUBJECT:

STAFF REQUIREMENTS - SECY-96-269 - RENEWAL OF l

THE MEMORANDUM OF UNDERSTANDING BETWEEN THE 5

U.S. NUCLEAR REGULATORY COMMISSION AND THE FOOD AND DRUG ADMINISTRATION This is to advise you that the Commission has n+ objected to renewa] of the MOU between NRC and FDA subject to the following i

comments.

I 1.

While revision to the MOU is not necessary, the Commission i

interprets item II.B.2 (4) to mean that the Office of State Programs makes training available to Agreement State program personnel.

2.

The staff should notify the appropriate Congressional oversight committees of the renewal of the MOU.

3, The Federal Reaister notice should be modified as noted in the attachment.

Attachment:

As stated cc:

Chairman Jackson I

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Commissioner Rogers Commissioner Dicus Commissioner Diaz commissioner McGaffigan OGC OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

SECY NOTE:

THIS SRM AND SECY-96-269 WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.

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070005 9702070086 970129 l

PDR 10CFR

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[7590-01]

NUCLEAR REGULATORY COMMISSION MEMORANDUM 0F UNDERSTANDING BETWEEN THE U.S. NUCLEAR REGULATORY COMMISSION AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION AGENCY:

U.S. Nuclear Regulatory Commission 7

ACTION: Notice of renewal of Memorandum of Understanding (MOU) between the U.S. Nuclear Regulatory Commission and the U.S. Department of Health and Human Services, Food and Drug Administration (DHHS. FDA).

SUMMARY

The NRC and the DHHS FDA signed a MOU on August 26, 1993, which describes the respective roles of the FDA and NRC for' regulating; medical devicesT;a'ndiradiopharniaceuticalsicontaining radi.oactive~ materials, and the coordination between the two agencies.

The MOU was noticed in the Federal Reaister on September 8. 1993 (58 FR 47300).

This notice announces the 3-year renewal of the MOU. with no changes.

FOR FURTHER INFORMATION, CONTACT: Larry W. Camper. Office of Nuclear Material Safety and Safeguards, MS 6-4-3 T.-81Fc5. U.S. Nuclear Regulatory Commission.

Washington. DC 20555. Telephone 301-415-7231.

Larry W. Camper, Chief Medical. Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety. NMSS (date)