Document ID: FDA-2009-D-0125-0010
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Researchers on Radioactive Drug Research Committee: Human Research without Investigational New Drug Application; Availability
Posted Date: 2010-08-02T04:00Z

[Federal Register: August 2, 2010 (Volume 75, Number 147)]
[Notices]               
[Page 45130-45131]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au10-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0125]

 
Guidance for Industry and Researchers on the Radioactive Drug 
Research Committee: Human Research Without an Investigational New Drug 
Application; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry and researchers entitled ``The 
Radioactive Drug Research Committee: Human Research Without an 
Investigational New Drug Application.'' This guidance provides 
information to those using radioactive drugs for certain research 
purposes to help determine whether research studies may be conducted 
under an FDA-approved radioactive drug research committee, or

[[Page 45131]]

whether research studies must be conducted under an investigational new 
drug application (IND). It also offers answers to frequently asked 
questions on conducting research with radioactive drugs, and provides 
information on the membership, functions, and reporting requirements of 
a radioactive drug research committee approved by FDA.

DATES:  Submit either electronic or written comments on agency 
guidances at any time.

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Orhan Suleiman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10901 New 
Hampshire Ave., Bldg. 22, rm. 2202, Silver Spring, MD 20993-0002, 301-
796-1471.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
researchers entitled ``The Radioactive Drug Research Committee: Human 
Research Without an Investigational New Drug Application.''
    In a document published in the Federal Register on July 25, 1975 
(40 FR 31298), FDA changed the conditions under which new radioactive 
drug and biological products could be used. First, the Agency 
terminated a 1963 order from the Commissioner of Food and Drugs (28 FR 
183, January 8, 1963) that had exempted radioactive new drug and 
biological products for investigational use in humans from new drug 
requirements (21 CFR part 312), as long as they were shipped consistent 
with regulations issued by the then Atomic Energy Commission (AEC). FDA 
and AEC had agreed that all radioactive drugs and biological products 
should now become subject to the same requirements for investigational 
use as other new drugs under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) and section 351 of the Public Health 
Service Act (42 U.S.C. 262). Simultaneously, the Agency issued 
regulations (Sec.  361.1 (21 CFR 361.1)) explaining when radioactive 
drugs for basic science and medical research would not be subject to 
the same requirements for investigational use as other new drugs.
    Today, research studies with a radioactive drug or biological 
product may be conducted in a number of ways: (1) Under an IND (part 
312), (2) exempt from IND requirements (Sec.  312.2), or (3) under 
certain conditions, with the supervision and approval of an FDA-
approved Radioactive Drugs Research Committee (RDRC) (Sec.  361.1).
    This guidance discusses the conditions under which research with a 
radioactive drug may be conducted under Sec.  361.1. Appendices to the 
guidance answer frequently asked questions about those conditions and 
provide additional information on RDRCs. Appendix A of the guidance 
answers questions on basic science research with radioactive drugs. 
Appendix B addresses approval by the RDRC and the information that must 
be submitted by investigators to the RDRC. Appendix C discusses the 
limits on the pharmacological dose, and Appendix D discusses the limits 
on the radiation dose. Each of these appendices also includes a summary 
of the regulations. Appendix E provides information on the membership, 
functions, and reports of an RDRC. The final appendix, Appendix F, is 
an RDRC review criteria checklist, indicating the areas on which the 
RDRC will focus when considering a proposed research study.
    In the Federal Register of June 3, 2009 (74 FR 26703), FDA 
announced the availability of a draft guidance for industry and 
researchers entitled ``The Radioactive Drug Research Committee: Human 
Research Without an Investigational New Drug Application.'' The notice 
gave interested persons an opportunity to comment by September 1, 2009. 
We received comments from seven institutions, organizations, and 
individuals. We have carefully considered the comments and, where 
appropriate, have made corrections, added information, or clarified the 
information in the guidance in response to the comments or on our own 
initiative.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on determining whether human research with a 
radioactive drug can be conducted under a radioactive drug research 
committee. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: July 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-18853 Filed 7-30-10; 8:45 am]
BILLING CODE 4160-01-S