ML20056D309

Requests Approval for Proposed MOU Between NRC & Us Fda. Recommends Approval

ML20056D309
Person / Time
Issue date:	07/26/1993
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-93-205, NUDOCS 9308110392
Download: ML20056D309 (12)

Text

-

e e e o,. c

, e a e o e 1. c...... 1 c

,, a c n m Tu c r a.

~

e

. 5Eb hh h

O f * "%,

4 f.

A

.i n

eoc t

.e><ciee,ereee POLICY ISSUE July 26, 1993 (Notation Vote)

SECY-93-205 FOR:

The Co.amissioners FROM:

James M. Taylor Executive Director for Operations

{

1

SUBJECT:

PROPOSED MEMORANDUM 0F UNDERSTANDING BETWEEN THE FOOD AND DRUG ADMINISTRATION AND THE NUCLEAR REGULATORY COMMISSION PURPOSE:

l I

To request approval for the proposed Memorandtm of Understanding (MOV) between the U.S. Nuclear Regulatory Commission and the U.S. Food and Drug Administration (FDA).

BACKGROUND:

Both the FDA and NRC have responsibility for regulating medical devices and radiopharmaceuticals containing radioactive material. As a consequence of our related areas of regulation, there is a need to clarify our respective roles, to foster better interaction between us, and to develop mechanisms of information exchange, to better accomplish our respective missions.

During the Incident Investigation Team (IIT) investigation involving the therapy misadministration at Indiana Regional Cancer Center, there were instances of confusion over the ability to share information between the two agencies.

In an effort to formalize the mechanisms for the exchange of information between the FDA and NRC, to prevent confusion in the future, and to proceed with action 3c of the staff action plan contained in COMSECY 023, representatives of FDA and NRC staff met and developed a proposed MOU (enclosure).

It should also be noted that Wayne Kerr, Chairman of the Organization of Agreement States, was given an opportunity to comment on the draft 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 this MOV completed by August 6, 1993.

Therefore, the staff requests that the Commission approve the proposed MOU. A joint signing ceremony with the FDA Commission would be planned.

I

Contact:

James A. Smith, NMSS NOTE:

TO BE MADE PUBLICLY AVAILABLE 301-504-2613 WHEN THE FINAL SRM IS MADE AVItILABLE au,,.)a.

h 0308M 03M~VIPg l

g

4 The Commissioners RECOMMENDATION:

That the Commission approve the MOU between NRC and FDA.

COORDINATION:

The Office of the General Counsel has no legal obje tion to this document.

Ik aaes

. ' T4 o 1

,e xecutiveeDirector

/

for Operations

Enclosure:

Proposed MOV 1

Commissioners' comments or consent should be provided directly to trw Office of the Secretary by COB Thursday, July 29, 1993.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Tuesday, July 27, 1993, with an infor-mation copy to the Office of the Secretary.

If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

I DISTRIBUTION:

Commissioners OGC OCAA OIG I

OPA OCA OPP REGIONAL OFFICES EDO

~

SECY 4

I 4

r M

FINAL DRAFT:

7/26/93 MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S.

NUCLEAR REGULATORY COMMISSION AND THE U.S.

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION l

The Nuclear Regulatory Commission (NRC) and the Food and Drug Adrainistration (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 these products are the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Biological Evaluation and Research (CBER).

The organizations in l

NRC that are principally responsible for these products are the Office of Nuclear Materials Safety and Safeguards (NMSS) and the Office of State Programs (OSP). For their respective authorities, l

the agencies hereby agree as follows:

I Purpose and Scope A.

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

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

B.

This MOU covers only those medical devices, 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

" biologic" is used in the Public Health Service Act (42 USC 262).

A biological product is either a drug or a i

device and is described in Part II, FDA, of this MOU.

l The terms " byproduct material," " source material," and l

"special nuclear material" are defined in Section l

11(e), (z), 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 j

(radioimmunoassay); and teletherapy and brachytherapy i

sources, systems, and accessory devices.

Biologics affected by this MOU include, but are not limited to:

I I

~~.

L i

i s

l l

7 f

t i licensed in vitro diagnostic kits (radioimmunoassay),

and radiolabeled biologics.

Drugs affected by this MOU

{

include all those that contain radioactive atoms derived from reactor byproduct material.

II.

' Authority and Reculatory Procram A.

FDA i

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

products, i.e.,

drugs, devices, and biologics.

1.

FDA/CDRH l

l The p.rincipal 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 i

Devices Act of 1992.

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

follows:

i "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 i

function of the body of man or other animals, and which does not-achieve its primary inteaded' 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:

i

{

l

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

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

(2) review of voluntary and mandatory medical device reports; and i

(3) enforcement activities such as routine and directed inspections, product removals, recalls, warning letters, and case actions such as seizure, injunction, prosecution, and civil penalties.

2.

FDA/CDER The principal statute under which FDA/CDER regulates drugs for human use is the Federal Food, Drug, and Cosmetic Act, as amended.

Section 201(g) (1) of the Federal Food, Drug, and Cosmetic Act, as 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 official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any I

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

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

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

t 3.

FDA/CBER

i d

I All biological products are either drugs or devices, and are regulated under both the Federal Food, Drug, and Cosmetic Act, as amended, and the Public Health Service Act.

i 21 CFR 600.3(h) defines biological products as follows:

"...any virus, therapeutic serum, toxin, or antitoxin, or analogous product applicable to the prevention, i

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; r

(2) review of voluntary and mandatory adverse reaction i

reports and biological product defect reports; (3) enforcement activities such as routine and i

directed inspections, product removals, recalls, warning letters, and case actions such as seizure, injunction, prosecution, and civil penalties.

B.

NRC 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 4

Act of 1969, as amended, and other applicable statutes.

l NRC responsibilities include protecting public health

[

and safety, protecting the environment, and i

safeguarding materials in the interest of national security.

i 1.

NRC/UMSS i

NMSS's responsibilities for the medical use of byproduct material include, but are not limited to:

l (1) licensing and inspection of medical, industrial, i

academic and commercial uses of byproduct i

material; b

i l

-~.

1 1

4 (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 nuclear and i

other radioactive materials; and (3) 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 material, or the radiation therefrom, to human beings in the practice of medicine.

i 2.

NRC/OSP j

l OSP's responsibilities for the medical use of byprod ct materials include, but are not limited to:

(1) negotiation of Agreements with States under section 274 of the Atomic Energy Act of 1954, as amended; 1

(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 l

(4) training of, and consultation with, Agreement States on radiological public health and safety issues.

3.

Acreement States 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 the NRC and the Governor of a State.

Agreement States use their own authority to regulate these materials.

l 1

III. Elements of Coordination e

s i

W A.

Notification of Product Complaints, Misadministrations, or Emeroency Situations Both agencies agree to promptly inform each other whenever they receive a report or otherwise become aware of a potential public health problem such as a malfunction, failure, reportable event, or a l

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 thar appropriate FDA and/or NRC actions are initiated on the basis of any necessary compliance or follow-up objectives.

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

B.

Coordination of Investications I

Upon request, FDA and NRC will assist each other, to the fullest extent possible, in the investigation of incidents or c7mplaints involving products of mutual l

regulatory concern.

For the purposes of this MOU, 1

investigations will be considered to include inspections in response to incidents or' events, as well l

as, to 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 inspections or observer invitations can be requested or

{

extended by either agency, when deemed necessary, to ensure that information obtained from an investigation i

is collected, shared and acted upon in a timely and j

coordinated manner.

Both agencies will make every reasonable effort to accommodate joint inspection er I

observer requests depending'upon-availability of

)

personnel and current FDA or NRC priorities.

Each i

agency will assign one or more persons to assure that investigations are coordinated in a manner that maximizes regulatory efficiency and minimizes duplication of effort.

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

1.

Investication Information Exchance Both agencies agree to an exchange of information with-respect to investigations.

The purpose of these exchanges is to provide expert technical assistance to either agency and to assist either agency by reducing or eliminating any duplication of effort.

The sharing of information between FDA and NRC (and Agreement States as appropriate) will be exercised to the extent

. s...

s

-4 authorized by law, and by 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 exchanged between the agencies and that fall within the definition of trade secret, or confidential commercial or financial information.

Both agencies 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 officers in accordance with 21 CFR 20.90.

If a request calls for a disclosure determination regarding proprietary information such as a Freedom of Information Act request, response to a Congressional inquiry, or in cases where either agency must comply with various regulatory or public information responsibilities, for any such information obtained from the other agency, that agency will be notified of the request.

The notified agency will be responsible for making any needed contact with the submitter of the protected information and accept the responsibility for evaluating the submitter's comments prior to rendering the disclosure determination.

To reserve the right of maximum control over actual disclosure of its own records, each agency shall retain 4

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

2. NRC Licensee and Acreement State Notifications

V Upen 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 Premarketina and Prelicensina Information Exchance 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 agencies 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 officers in accordance with 21 CFR 20.90.

This information will include, but is not limited to:

i) design, chemical and physical form of the material or the device; ii) manufacture / preparation; iii) prototype testing; iv) quality assurance and control; v) labeling per regulatory requirements; vi) intended use; vii) safety analysis; 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 notifications to manufacturers, operators, licensees, or patients.

FDA and NRC will also offer each other the opportunity to comment on regulations, regulatory guides or other communications that refer to activities, policies, or regulations of 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.

t d E.

Advisory Committees NRC and FDA will make the other agency aware of and, to the extent possible, allow participation by a i

representative from the other agency in any Advisory Committee which advises on issues related to this MOU.

l IV.

Name and Address of Participatina Acencies l

Food and Drug Administration f

5600 Fishers Lane Rockville, MD 20857 and the Nuclear Regulatory Commission Washington, D.C.

20555 l

V.

Liaison Officers i

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

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

These lists with current work and home phone numbers will be exchanged among the liaison officers.

Liaison officers are as follows:

A.

For the Food and Druc Administration Center for Devices and Radiological Health 1.

Director, Office of Compliance and Surveillance (currently:

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

301-427-1100 2.

Center for Drug Evaluation and Research (currently:

A.

Eric Jones, M.D.)

5600 Fishers Lane Rockville, MD 20857 Telephone:

301-443-3500 3.

Center for Biologic Evaluation and Research Deputy Director, Office of Compliance (currently: P. Michael Dubinsky) 1401 Rockville Pike Rockville, MD 20850 Telephone:

301-295-9066

s a B.

For the Nuclear Regulatory Commission Director, Office of Nuclear Material Safety and Safeguards

]

(currently:

Robert M. Bernero) i OWFN MS-6E-6 11555 Rockville Pike i

Rockville, MD 20852 Telephone: 301-504-3352 VI.

Annual Inter-Acenc1 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 f

authorized representatives of FDA and NRC.

It may be i

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 AND DRUG ADMINISTRATION BY BY

(

TITLE TITLE i

DATE DATE 1

..