[Federal Register Volume 74, Number 105 (Wednesday, June 3, 2009)]
[Notices]
[Page 26703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12832]



[[Page 26703]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry and Researchers on the Radioactive 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availability of a draft guidance for industry and researchers entitled 
``The Radioactive Drug Research Committee: Human Research Without an 
Investigational New Drug Application.'' This draft guidance provides 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 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:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by September 1, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:  Orhan Suleiman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 2206, Silver Spring, MD 20993-0002, 301-
796-1471.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and researchers entitled ``The Radioactive Drug Research Committee: 
Human Research Without an Investigational New Drug Application.''
    On July 25, 1975 (40 FR 31298), FDA changed the conditions under 
which new radioactive drug and biological products could be used. 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 (part 312 (21 CFR part 312)), as long as they were shipped 
consistent with regulations issued by the 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 
products 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 draft 
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, reports, and monitoring 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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 361.1 have been approved under OMB 
control number 0910-0053.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

IV. 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: May 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12832 Filed 6-2-09; 8:45 am]
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