U.S. Nuclear Regulatory Commission

Policy and Guidance Directive FC 86-1, Revision 1, "Radioactive Drug Research Committees"

HPPOS-262 PDR-9306070215

Title: Policy and Guidance Directive FC 86-1, Revision 1,

"Radioactive Drug Research Committees"

See the memorandum from R. E. Cunningham to Distribution

dated August 28, 1989. This directive provides guidance

about review of requests from specific licensees (both

limited scope and broad scope) that want to administer

radioactive materials to humans for research purposes.

Background Information: Some research studies involve the

administration of radioactive materials to humans that are

within the purview of the Food and Drug Administration's

(FDA's) Radioactive Drug Research Committees (RDRCs). The

regulations establishing RDRCs and defining their role are

found in Section 361.1 of 21 CFR 361 revised April 1985,

and are contained in Enclosure 1. The most current listing

of FDA-approved RDRCs was revised July 27, 1988, and is

contained in Enclosure 2. Enclosure 3 is a letter from FDA

to the chair-person of each FDA-approved RDRC, clarifying

the role of RDRCs and the types of studies that come within

an RDRCs purview. Enclosure 4 contains a sample limited

scope license condition, and Enclosure 5 contains a broad

scope license condition.

Keep in mind that an RDRC, acting in its official role as a

committee approved by FDA, may deal only with research

projects involving drugs. Accordingly, research studies

that involve a bone mineral analyzer, brachytherapy

sources, or other sealed sources are not within the scope

of Section 361.1 of 21 CFR 361. Further, Section 361.1

excludes clinical studies with a diagnostic or therapeutic

benefit. However, FDA has indicated that "this regulation

does not in any way prohibit an institution from involving

its Radioactive Drug Research Committee in other policy

matters, ... if it so chooses" (40 FR 31304, July 25, 1975).

Every broad scope licensee authorized to perform "medical

research" is also authorized to perform human research

studies. Therefore, most broad scope licensees are

required to confirm access to an approved RDRC as part of

the NRC license application or renewal process. Some are

only authorized for medical uses and in vitro uses under 10

CFR Parts 35 and 31, respectively, and do not need to

confirm access to an RDRC. Note that the FDA allows an

RDRC at one institution to review and approve research

studies proposed to be done at another institution that

does not have its own RDRC. However, an RDRC at one

institution is not required, by FDA regulations, to assist

a second organization by reviewing its research proposals.

The NRC has received reports that several institutions have

decided that they did not want to accept responsibility for

having their RDRC review proposals from other organizations.

On occasion, non-medical institutions have proposed to

perform Section 361.1 human research studies. Typically,

these institutions do not have the required nuclear

medicine personnel to perform the studies. In the past,

such situations have been resolved after encouraging the

institution to associate with, or contract to, a nearby

medical institution in order to secure the appropriate

personnel and facilities. If the information specified

below has been supplied and we are satisfied that all

regulations are met, the proposed human research study may

be authorized.

Licensing: NRC has authorized its licensees to conduct

these types of studies provided certain criteria are met or

certain commitments are made.

1. Specific Licenses of Limited Scope - Be sure that:

a. The proposed authorized user is a physician as

defined in paragraph 35.2 of 10 CFR Part 35.

b. The proposed physician-user has adequate training

and experience. Any physician whose training and

experience meet or exceed those specified in Section 35.910

or 35.920 of 10 CFR Part 35 has adequate training and

experience. Physicians with less training and experience

must be considered on a case-by-case basis; contact the

Medical, Academic, and Commercial Use Safety Branch staff

for assistance.

c. The proposed research project meets all the

requirements of 21 CFR 361.1 and has been approved by an

FDA-approved RDRC. If the reviewer is unsure of whether

the RDRC has the authority to permit a proposed human

research study, as required in 21 CFR 361.1, contact the

Medical, Academic, and Commercial Use Safety Branch staff

for assistance.

d. The licensee has adequate facilities, equipment,

and radiation safety procedures for handling the

radioactive material proposed for use in the research

study. In most cases, the licensee will not need to supply

additional information because the typical RDRC research

study involves use of no more than several millicuries of

tritium or carbon-14 or other materials that require

radiation safety procedures similar to those required by

Section 35.100 of 10 CFR Part 35.

Enclosure 4 contains a sample license condition for a

limited scope medical license showing how a human research

study may be authorized.

2. Specific Licenses of Broad Scope - Be sure that:

a. The licensee's description of its Radiation Safety

Committee's (RSC's) criteria for selecting users should

describe criteria for those wanting to administer

radioactive materials to humans for research purposes.

These proposed users must be physicians as defined in

Section 35.2 of 10 CFR Part 35 and must have adequate

training and experience. If the licensee proposes to

accept training and experience that are less than those

described in Sections 35.910 and 35.920 of 10 CFR Part 35,

the reviewer must be sure that the criteria are adequate

and reasonable in light of the licensee's entire program

and should consult with the Regional section leader before

accepting the proposed criteria. The section leader may in

turn wish to consult with members of the ACMUI before

making a licensing decision.

b. The licensee's description of its RSC's criteria

for approving proposed uses of radioactive material shall

require, among other things, that research studies

involving the administration of radioactive materials to

humans are approved by a FDA-approved RDRC. In its review

of proposed RDRC studies, it is expected that the RSC will

also consider the need for special equipment and facilities

or for special radiation safety procedures.

Enclosure 5 contains a sample license condition for a broad

scope license showing how a human research study may be

authorized.

Regulatory references: 10 CFR 31, 10 CFR 35, 21 CFR 361

Subject codes: 1.3, 11.3, 11.5, 12.13

Applicability: Byproduct material