ML20133B525

Informs NRC of Staff Plans for Renewal of MOU Between NRC & Us Dept of Health & Human Svcs,Fda,

ML20133B525
Person / Time
Issue date:	12/30/1996
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-96-269, SECY-96-269-R, NUDOCS 9701030238
Download: ML20133B525 (21)

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POLICY ISSUE (NEGATIVE CONSENT)

December 30, 1996 SECY-96-269 IQ:

The Commissioners fBQM:

James M. Taylor, Executive Director for Operations

SUBJECT:

RENEWAL OF THE MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S.

NUCLEAR REGULATORY COMMISSION AND THE FOOD AND DRUG ADMINISTRATION PURPOSE:

To inform the Commission of the staff's plans for renewal of the 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 (FDA), dated August 26, 1993 (Attachment 1).

BACKGROUND:

Generally speaking, both the FDA and NRC have responsibility for regulating medical devices and pharmaceuticals containing radioactive materials. As a consequence of our related areas of regulation, there was a need to clarify our respective roles to foster better interaction and develop mechanisms of information exchange, to better accomplish our respective missions.

In an effort to formalize and facilitate the exchange of information between NRC and the FDA, representatives of the FDA and NRC staff met periodically to develop a proposed MOU. On May 6, 1993, during the hearing before the Senate Committee on Governmental Affairs, concerning the Federal regulation of medical radiation uses, Senator John Glenn, Chairman of the Committee, expressed a desire to have the M0V completed expeditiously. On August 26, 1993, Ivan Selin, NRC Chairman, and David Kessler, Commissioner of FDA, signed the M00.

f CONTACT: Torre Taylor, NMSS NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN D

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l DISCUSSION:

Section VIII of the MOU requires, in part, that the agencies evaluate the effectiveness of the MOU every 3 years, at which time either agency has the option to renew, modify, or cancel the MOU.

Since signing the MOU, information on devices and drugs under review by one or i

both agencies has been exchanged more efficiently and expeditiously because of l

agreements and assurances in the M00. The staffs have participated in joint meetings with researchers and industry representatives in areas such as intravascular brachytherapy, high-dose-rate remote afterloading brachytherapy, and software-controlled therapy planning systems. On a routine basis, the.

staffs communicate information regarding misadministratiors, medical device i

failures, and other issues of mutual regulatory concern.

As required by Section VI of the MOU, NRC and FDA Liaison Officers have met annually to evaluate the effectiveness of the MOU. At every meeting, it has been concluded that the MOU has been effective in fostering information exchange and interaction between NRC and FDA, and has assisted both agencies in accomplishing their respective missions.

In addressing the requirements of Section III of the MOU, during the third annual meeting, held August 8,1996, the MOV Liaison Officers agreed that the MOU should be renewed with no changes.

COORDINATION:

This paper has been coordinated with the Office of the General Counsel, which has no legal objection.

RECOMMENDATION:

Unless directed otherwise by the Commission, within 2 weeks of the date of this paper, the NRC staff intends to issue letters (Attachment 2) to the FDA Liaison Officers, confirming NRC's intent to renew the MOU. Unless FDA fails to confirm its intent to renew the MOV or requests modifications to the M00, these letters will effectively renew the MOU. Upon renewal of the MOU, the staff intends to publish a Federal Reaister notice of renewal (Attachment 3).

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lor ecutive irector for Operations Attachments:

1) FDA/NRC MOV

2) Letters to FDA Liaison Officers

3) Proposed FRN

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SECY NOTE: In the absence of instructions to the contrary, SECY will notify the staff on January 16, 1997 that the Commission, by negative consent, assents to the action proposed in this paper.

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MEMORANDUM OF UNDERSTARING l

BETWEEN THE U.S. NUCLEAR REGULATORY COMMISSION AND THE

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

!l FOOD AND DRUG ADMINISTRATION I

The Nuclear Regulatory Commission (NRC) and the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) have regulatory responsibilities concerning medical devices, drugs, and biological products utilizing byproduct, source, or special nuclear material.

The organizations in FDA that are principally responsible for regulating these products are the Center for Devices and Radiological Health (CDRN), the Center for Drug Evaluation and Research (CDER), and the Center for Biological Evaluation and Research (CBER).

The organizations in NRC that are principally responsible for regulating these products are the Office of Nuclear Materials Safety and Safeguards (NMSS), the Office of Nuclear-Reactor Regulation (NRR), and the Office of State Programs,(OSP). For their respective authorities, the agencies hereby agree as follows:

I.

Purnose and Scone A.

The purpose of this Memorandum of Understanding (h0U) is to coordinate existing NRC and FDA regulatory programs for medical devices, drugs, and biological p-educts utilizing byproduct, source, or special nuclear material.

These regulatory programs include activities for evaluating and authorizing the manufacture, sale, distribution, licencing, and labeled intended use of such products.

5.

This MOU covers only those medical devices (including I

utilization facilities used for medical therapy), drugs and biological products utilizing byproduct, source, or special nuclear material regulated under the Atomic Energy Act of 1954, as amended.

The terms " drug" and

" device" are defined in the Federal Food, Drug, and Cosmetic Act, as amended (21 USC 321(g) and (h)), and is used in the Public Health Service Act (42

" biologica USC 262).

A biological product is either a drug or a device and is described in Part II, FDA, of this MOU."

The terms " byproduct material," " source material," and "special nuclear material" are defined in Section 11(a), (s), and (aa) of the Atomic Energy Act of 1954, as amended, and described in Part II, NRC, of this MOU.

, Medical devices affected by this MOU include, but are not limited to: in vitro diagnostic kits (radioimmunoassay); utilization facilities licensed to ATTACHMENT 1 e--.

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4 perform medical therepy; and teletherapy and brachytherapy sources, systems, and accessory devices.

Biologics affected by this MOU include, but are not limited to: licensed in vitro diagnostic kits (radioimmunoassay), and certain radiolabeled biologics for in-vivo use.

Drugs affected by this MOU include all those that contain byproduct, source, or special nuclear material.

i II.

Authority and Reaulatory Procram A.

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FDA is responsible for assuring the safety, effectiveness, and proper labeling of medical

products, i.e.,

drugs, devices, and biologics.

1.

FDA/CDRH The principal statute under which FDA/CDRH regulates devices is the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990 and the Medical Devices Act of 1992.-

Section 201(h) of the Federal Food, Drug, and Cosmetic Act, as amended, defines " device" as follows:

"The term " device"*** means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar-or related article, including any component, part, or accessory, which is --

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."

FDA/CDRH programs intended to ensure the safety and effectiveness of devices include, but are not limited to, the following:

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. (1) review of investigational device exemptions (IDE),

presarket notification (510(k)), presarket approval (PMA);

(2) review of. voluntary and mandatory medical device reports; and (3) enforcement activities such as routine and directed inspections, product rwmovals, recalls, 4

warning letters, and case actions such as seizure, injunction, prosecution, and civil penalties.

2.

FDA/CDER The principal statute under which FDA/CDER regulates 4

drugs for human use is the Federal Food, Drug, and Cosmetic Act, as amended.

Section 201(g)(1) of the Federal Food, Drug, and i'

Cosmetic Act, an amended, defines " drug" as follows:

The term " drug" means (A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or 1

official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis,. cure, mitigation, treatment, or prevention l

of disease in man or other animals; and (C) articles i

(other than food) intended to affect the structure or j

any function of the body of man or other animals; and 1

(D) articles int 9nded for ure as a component of any j

articles specified in clause (A), (B), or (C).

FDA/CDEP functions intended to ensure the effectiveness, safety, and quality of drugs for human f

use include, but are not limited to, the fo11' wing:

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i (1) review of clinical and bioavailability studies, l

manufacturing processes, and testing methods; i

l (2) review of voluntary and mandatory adverse reaction reports and drug product defect reports; j

j (3) enforcement activities such as routine and directed inspections, product removals, recalls, warning letters, and case actions such as seizure, s

2 injunction, prosecution, and civil penalties.

3.

FDA/CEER i

The principle statute under which FDA/CBER regulates i

biological products is the Public Health Service Act.

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" However, all biological prodnets have also been defined as either drugs or devices under tae *ederal Food, I

Drug, and Cosmetic Act, as amended.

As provided in Section 351(a) of the Public Health Service Act, 21 CFR 600.3 (h) defines biological products as follows:

...any virus, therapeutic serum, toxin, or antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man..."

FDA/CBER functions intended to ensure the effectiveness, safety, and quality of biological products for human use include, but are not limited to, the following:

(1) review of clinical and bioavailability studies, manufacturing processes, and testing methods; (2) review of voluntary and mandatory adverse reaction reports and biological product defect reports; (3) enforcement acLivities such as routine and directed inspections, product removals, recalls, warning letters, and case actions such as seizure, injunction, prosecution, and civil penalties.

B.

HEC NRC is responsible for licensing and regulating nuclear facilities and material and for conducting research in support of the licensing and regulatory process, as mandated by the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and in accordance with the National Environmental Policy Act of 1969, as amended, and other applicable statutes.

NRC responsibilities include protecting public health and safety, protecting the environment, and safeguarding materials in the interest of national security.

1.

KRC/MMSS NMSS's responsibilitios for the medical use of l

byproduct, source, or special nuclear material include, but are not lini.*.ed to:

(1) licensing and inspection of medical, industrial, academic and commercial uses of byproduct, source, or special nuclear material;

. (2) development and implementation of NRC policy for the regulation of activities involving safety, quality, approval, and inspection and enforcement regarding the use and handling of byproduct, source, or special nuclear material; (3) reviewing of sealed sources or devices to provide reasonable assurances that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property; and 4

(4) monitoring and investigation, as necessary, of misadministrations as defined in 10 CFR 35.2, which occur during the intentional internal or external administration of byproduct, source, or special nuclear material, or radiation therefrom, to human beings in the practice of medicine.

2.

NRC/OSP OSP's responsibilities for the medical use of byproduct, source, or special nuclear material include, but are not limited to:

(1) negotiation of Agreements with States under secti.on 274 of the Atomic Energy Act of 1954, as amended; (2) evaluation of the program of a new Agreement State to determine if it is adequate to protect the public health and safety, and if it is compatible with the NRC program; (3) periodic evaluation of the Agreement State programs to determine continued adequacy and compatibility; and (4) training of, and consultation with, Agreement states on radiological public health and safety issues.

3.

NRC/NRR NRR's responsibilities for the medical use of utilization facilities, include, but are not limited to:

(1) licensing and inspection of utilization facilities for medical therapy, pursuant to 10 CFR 50.21 and 10 CFR 50.41; and

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• (2) development and implementation of NRC policy for the regulation of activities involving safety, quality, approval, and inspection and enforcement regarding the use of utilization facilities for medeial therapy.

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4.

Aaremment States l

Under section 274 of the Atomic Energy Act of 1954, as amended, the Commission is authorized to discontinue its regulatory authority for certain radioactive materials if a state has a program that is adequate to protect the public health and safety and compatible with NRC's program.

The transfer of this regulatory authority is executed through an Agreement between the Chairman of NRC and the Governor of a State.

Agreement States use their own authority to regulate these materials.

III. Elements of Coordination A.

Notification of Product Coenlaints. Misadministrations, or Emeraancy situations Both agencias agree to promptly inform each other whenever they receive a report or otherwise become aware of a potential public health problem such as a m:lfunction, failure, reportable event, or a misadministration involving products of mutual regulatory concern.

Each agency will assign one or more contact persons in order to ensure that such information is promptly exchanged and that appropriate FDA and/or NRC actions are initiated on the basis of a..y necessary compliance or follow-up objectives.

ach organization will promptly notify the other when there is a change in an assigned contact person.

B.

Coordination of Irzvestinations Upon request, FDA a.M NRC will assist each other, to the fullest extent possible, in the investigation of incidents or complaints involving products of mutual regulatory concern. For the purposes of this MOU, investigations will be considered to include inspections in response to incidents or events, as well as, formal investigations initiated in accordance with each agency's internal procedures.

(Agreement States will be involved as appropriate to the specific situation.)

During the term of this agreement, joint

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inspections or observer invitations can be requested or

, extended by either agency, when deemed necessary, to a

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I ensure that information obtained from an investigation is collected, shared and acted upon in a timely and coordinated manner.

Both agencies will make every reasonable effort to accommodate joint inspection or observer requests depending upon availability of i

personnel and current FDA or NRC priorities.

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agency will assign one or more persons to assure that investigations are coordinated in a manner that j

maximizes regulatory efficiency and minimizes duplication of effort.

Each agency will promptly notify the other when there is a change in an assigned j

contact person.

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1. Investiaation Information Exchance i

Both agencies agree to an exchange of information with respect to investigations.

The purpose of i

these exchanges is to provide expert technical j

assistance to either agency and to assist either agency by reducing or eliminating any duplication of f

effort.

The sharing of information between FDA and NRC (and Agreement States as appropriate) will be j

exercised to the extent authorized by law, and by l

NRC and FDA directives, statutes, and regulations, and will be consistent with the respective agency's mission.

Both agencies recognize the need to protect from public disclosure, data and information that are i

j exchanged between the agencies and that fall within a

the definiticn of trade secret, or confidential I

j commercial or financial information.

Both agencies i

agree to exchange proprietary information in l

accordance with applicable regulations.

If FDA i

provides NRC with trade secret information, there shall be an additional written agreement in the form l

of an exchange of letters between the appropriate 1

i liaison officers in accordance with 21 CFR 20.90.

j If a request calls for a disclosure determination l

1 regarding proprietary information such as a Freedom of Information Act request, response to a i

Congressional inquiry, or in cases where either i

agency must comply with various regulatory or public i

information responsibilities, for any such j

information obtained from the other agency, that i

agency will be notified of the request.

The j

notified agency will be responsible for making any needed contact with the submitter of the protected information and accept the responsibility for j

evaluating the submitter's comments prior to rendering the disclosure determination.

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. To reserve the right of maximum control over actual disclosure of its own records, each agency shall retain legal authority and the commensurate responsibility over disclosure of those documents provided to the other agency.

Upon request, FDA and NRC will:

a) provide copies of Establishment or User Site Inspection Reports; b) provide copies of all analytical data and correspondence of significance related to 1

investigations or activities associated with an area of mutual regulatory concern; c) provide copies of official legal or compliance actions taken against firms or licensees of mutual interest; and 1

d) participate in meetings with regulated industry covering issues of mutual regulatory concern.

2. NRC Licensee and Aareement State Notifications Upon request, NRC will promptly notify NRC licensees and Agreement State Program Directors of any public health issues or other important user communications initiated by FDA as the result of joint investigations or other activities involving products of mutual regulatory concern.

C.

Product Pr==arketina and Prelicensina Information Exchange To the extent practicable the two agencies will share information concerning new technology or methods under development or review, including devices, drugs, or biologics, for which regulations have not yet been developed, or is related to the mission of the other agency.

Both agenciec agree to exchange proprietary information in accordance with applicable regulations.

If FDA provides NRC with trade secret information, there shall be an additional written agreement in the form of an exchange of letters between the appropriate liaison officerr in accordance with 21 CFR 20.90.

This information may include, but is not limited to:

1) design, chemical and physical form of the material or the device;

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l ii) manufacture / preparation; iii) prototype testing; iv) quality assurance and control; v) labeling per regulatory requirements; vi) intended use; vii) safety analysis; l

viii) installation; ix) servicing; x) leak testing; xi) operating instructions; and xii) emergency / safety instructions.

D.

Sharina of Other Information FDA and NRC will offer each other the opportunity to comment on special notifications to manufacturers, operators, licensees, or patients.

FDA and NRC will also offer each other the opportunity to comment on i

regulations, regulatory guides or other communications that refer to activities, policies, or regulations of I

the other agency.

If practicable, the documents will be provided prior to issuance.

Either agency may request additional information when deemed necessary to complete its mission.

E.

Advisory Committees NRC and FDA will make the other agency aware of and, to the extent possible, allow participation by a representative from the other agency in any Advisory Committee which advises on issues related to this MOU.

IV.

Name and Eddress of Particiuatina Aaencias Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 and the Nuclear Regulatory Commission Washington, D.C. 20555 V.

Liaison Officers Each liaison officer will establish and maintain a call list of responsible persons within his or her organization.

l These call lists will designate specific persons for day-to-day contact on matters related to this NOU.

These lists I

with current work and home phone numbers will be exchanged i

. among the ISrlmar, cff'mers.

The nsis will be updated every six months or whenever.a ljasson efflear's or day-to-day contact person's phone.cumbe.r ctanges.

l Liaison officers are as fo13owsr A.

For the Food and Druo Administration l

1.

Center for Devices and Radiological Health l

Diractor, Office of Compliance and Surveillance (currently:

Mr. Ronald M. Johnson) 1390 Piccard Drive Rockville, MD 20850 Telephone:

301-594-2100 2.

Center for Drug Evaluation and Research Director, Office of Compliance (currently:

Charma A. Konnor) 5600 Fishers Lane Rockville, MD 20857 i

Telephone:

301-594-0054 l

l 3.

Center for Biologic Evaluation and Research Deputy Director, Office of Compliance (currently: P. Michael Dubinsky) 1401 Rockville Pike i

Rocky.ille, MD 20850 l

Telephone:

301-594-2066 B.

For the Nuclear Reaulatory Commission Director, Office of Nuclear Material Safety and Safeguards (currently:

Robert M. Bernero)

OWFN MS-6E-6 11555 Rockville Pike Rockville, MD 20852 Telephone: 301-504-3352 VI.

Annual Inter-Anency Meetina The liaison officers shall meet at least annually to evaluate the activities related to this MOU and make recommendations to agency heads on its effectiveness.

FDA and NRC will host the meeting on alternating years.

VII. Other Laws and Matters Nothing in this Memorandum of Understanding shall be deemed to restrict, modify, or otherwise limit the application or enforcement of any laws of the United States with respect to matters specified herein, nor shall anything in the

. Memorandum be construed as modifying the existing authority of either agency.

VIII. Effective Date. Modification and Termination of MOU This MOU will take effect when it has been signed by the authorized representatives of FDA and NRC.

It may be modified by mutual written consent or terminated by either agency upon a sixty (60) day advance written notice to the other agency.

The agencies agree to evaluate the agreement every three (3) years, at which time either agency would have the option of renewing, modifying or canceling the MOU.

APPROVED AND ACCEPTED FOR THE APPROVED AND ACCEPTED FOR THE NUCLEAR REGULATORY COMMISSION FOOD UG LATION BY M BY f /M M

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Mr. Philip J. Frappaolo, Deputy Director Office of Compliance Center for Devices and Radiological Health U.S. Department of Health and Human Services Food and Drug Administration 2098 Gaither Road Rockville, MD 20850

Dear Mr. Frappoalo:

This letter is to confirm that the U.S. Nuclear Regulatory Commission intends to renew the Memorandum of Understanding (MOU) between itself and the U.S. Department of Health and Human Services. Food and Drug Administration (FDA). At the third annual meeting under the MOU, held August 8.1996, NRC and the FDA evaluated the efficacy of the MOU and determined that it has been effective in promoting interaction and facilitating information exchange between the two agencies, thereby allowing both agencies to better accomplish their respective missions.

During the meeting, the liaison officers from both the FDA and NRC agreed that the MOU should be renewed.

I would appreciate confirmation, by letter, that the FDA agrees with the renewal of the MOU.

Sincerely.

$k pff Carl J. Pa) erie 1To. Director Office of Vuclear Material Safety and Safeguards A

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WASHINGTON, D.C. 30666-4001 Ms. Betty L. Jones. Deputy Director Office of Compliance Center for Drug Evaluation and Research j

U.S. Department of Health and iluman Services Food and Drug Administratio".

7520 Standish Place. Room. 254 Rockville. MD 20855

Dear Ms. Jones:

q This letter is to confirm that the U.S. Nuclear Regulatory Commission intends to renew the Memorandum of Understanding (MOU) between itself and the U.S. Department of Health and Human Services. Food and Drug Administration (FDA). At the third annual meeting under the MOU, held August 8,1996, NRC and the FDA evaluated the efficacy of the MOV and determined that it has been effective in promoting interaction and facilitating information exchange between the two agencies, thereby allowing both agencies to better accomplish their respective missions. During the meeting, the liaison officers from both the FDA and NRC agreed that the MOU should be renewed.

I would appreciate i

confirmation, by letter, that the FDA agrees with the renewal of the MOU.

Sincerely,

/W $ k Carl J. Paperiel Director Office of Nuclear Material Safety and Safeguards i

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NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. aose64001 Mr. P. Michael Dubinsky. Deputy Director Office of Compliance Center for Biologics Evaluation and Research U.S. Department of Health and Human Services Food and Drug Administration 1401 Rockville Pike Rockville. MD 20852

Dear Mr. Dubinsky:

This letter is to confirm that the U.S. Nuclear Regulatory Comission intends to renew the Memorandum of Understanding (MOU) between itself and the U.S. Department of Health and Human Services. Food and Drug Administration (FDA). At the third annual meeting under the MOU. held August 8. 1996. NRC and the FDA evaluated the efficacy of the MOU and determined that it has been effective in promoting interaction and facilitating information exchange between the two agencies, thereby allowing both agencies to better accomplish their respective missions.

During the meeting, the liaison officers from both the FDA and NRC agreed that the MOU should be renewed.

I would appreciate confirmation, by letter that the FDA agrees with the renewal of the MOU.

Sincerely.

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Carl J. Paperie irector Office of Nucle aterial Safety and Safeguards l

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MEMORANDUM TO:

David L. Heyer. Chief Rules Review & Directives Branch Division of Freedom of Information &

i Publications Services. ADM FROM:

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

SUBJECT:

RENEWAL OF MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S.

NUCLEAR REGULATORY COMMISSION AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES F0DD AND DRUG ADMINISTRATION Please arrange for publication of the attached Federal Reaister notice.

announcing the renewal of the Memorandum of Understanding between the U.S.

Nuclear Regulatory Commission and the U.S. Department of Health and Human Services. Food and Drug Administration.

Attachment:

FR Notice

Contact:

Torre Taylor. NMSS (301) 415-7900

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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 i

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 roles of the FDA and NRC, and the coordination bt. tween the two agencies. The MOU was noticed in the Federal Reaister on September 8,1993 (58 FR 47300). This notice announces the renewal of the MOU, with no changes.

FOR FURTHER INFORMATION, CONTACT:

Larry W. Camper, Office of Nucidar Material Safety and Safeguards MS 6-H-3, 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) i I