ML20216E574
| ML20216E574 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/1998 |
| From: | Catherine Haney NRC |
| To: | Swanson D AFFILIATION NOT ASSIGNED |
| References | |
| FRN-62FR42219, RULE-PR-35 NUDOCS 9804160245 | |
| Download: ML20216E574 (2) | |
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From: Catherine Haney p= ,, . $
To: internet:dswansonadruginfonet. pharm-epid.pitt.edu 3 4*}
Date: 4/15/98 9:51am ] M r.
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s "> ,f f Subjects 10 CFR Part 35 u ;- ,
tu As a result of the questions raised at the last ACMUI meeting,,I had onA of the working group members look into whether a change in 10 CFR 35.6 warn l warrented. Based on the information provided to me, I do not think that any l changes are needed. If you believe changes are still needed after reviewing the following, please let me know and explain why so I can investigate !
further. NOTE: I'll make sure this is discussed in the guidance document I associated with the rule. l l
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April 6, 1998 j
SUBJECT:
WHETHER A MEDICAL USE LICENSEE MUST OBTAIN A LICENSE LIENDMENT BEFORE PERFORMING RESEARCH INVOLVING HUMAN SUBJECTS WHICH IS FUNDED OR SUPPORTED BY THE FOOD AND DRUG ADMINISTRATION (FDA)
In connection with staff development of a proposed rule revising the medical use regulations at 10 CFR Part 35, an ACMUI member has raised an issue requiring interpretation of 10 CFR S 35.6. The specific issue is whether a medical use licensee performing research involving human subjects using byproduct material which is funded or supported by the FDA, must obtain a f license amendment pursuant to 10 CFR S 35.6 before conducting such research. '
Under S 35.6, medical use licensees may conduct such research provided that the research is conducted, funded, supportec, or regulated by another Federal agency which has implemented the Federal Policy for The protection of Human Subjects (Federal Policy). Otherwise, the licensee must apply for and receive approval of a specific amendment to its NRC license before conducting such research. (Also, whether or not a license amendment is required, licensees must obtain informed consent from human subjects and obtain prior review and approval of the research activities by an Institutional Review Board in accordance with the meaning of those terms under the Federal Policy.)
In 1991, FDA concurred in the final rule containing the Federal Policy and modified its regulations at 21 CFR Part 50 to conform to the Federal Policy to )
the extent permitted by the Federal, Food, Drug, and Cosmetic Act (and given the fact that FDA is a regulatory agency which rarely supports or conducts research under its regulations). Federal Policy for the Protection of Human Research Subjects, 56 Fed. Reg. 28003 (June 18, 1991); Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations, 56 Fed. Reg. 2802 (June 18, 1991), As stated in both of those cited notices of final rulemaking, FDA regulations share a >
common core with the Federal Policy and implement the fundamental principles embodied in that policy. In light of this, for the purposes of determining ,
! licensee compliance with S 35.6, a licensee using byproduct material in } , !
f conducting human research which is funded or supported by FDA, would not be [j l required to obtain a license amendment pursuant to 2 35.6 before conducting j such research. l l
9804160245 980415 PDR PR PDR 35 62FR42219
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April 6, 1998
SUBJECT:
WHETHER A MEDICAL USE LICENSEE MUST OBTAIN A LICENSE AMENDMENT BEFORE PERFORMING RESEARCH INVOLVING HUMAN SUBJECTS WHICH IS FUNDED OR SUPPORTED BY THE FOOD AND DRUG ADMINISTRATION (FDA)
In connection with staff development of a proposed rule revising the medical use regulations at 10 CFR Part 35, an ACMUI member has raised an issue i
requiring interpretation of 10 CFR S 35.6. The specific issue is whether a medical use licensee performing research involving human subjects using byproduct material which is funded or supported by the FDA, must obtain a license amendment pursuant to 10 CFR S 35.6'before conducting such research.
Under S 35.6, medical use licensees may conduct such research provided that the research is conducted, funded, supported, or regulated by another Federal i agency which han implemented the Federal Policy for The protectior ci Human
' Subjects (Federal Policy). Otherwise, the licensee must apply for and receive
! approval of a specific amendment to its NRC license before conducting such research. (Also, wl.ather or not a license amendment is required, licensees must obtain informed consent from human subjects and obtain prior review and approval of the research activities by an . Institutional Review Board in accordance with the meaning of those terms under the Federal Policy.)
In 1991, FDA concurred in the final rule containing the Federal Policy and modified its regulations at 21 CFR Part 50 to conform to the Federal Policy to l the extent permitted by the Federal, Food, Drug, and Cosmetic Act (and given l
the fact that FDA is a regulatory agency which rarely supports or conducts research under its regulations). Federal Policy for the Protection of Human Research Subjects, 56 Fed.. Reg. 28003 (June 18, 1991); Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for r Clinical Investigations, 56 Fed. Reg. 2802 (J une 18, 1991). As stated in L both of those cited notices of final rulemaking, FDA regulations share a common core with the Federal Policy and implement the fundamental principles embodied in that policy. In light of this, for the purposes of determining licensee compliance with 5 35.6, a licensee using byproduct material in
, conducting human research which is_ funded or supported by FDA, would not be l required to.obtain a license amendment pursuant to S 35.6 before conducting such research.
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CC: internet:stitt@madrad. radiology.wisc.edu, internet...
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