Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Notices 26703 

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Draft Guidance for Industry and 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. 

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availability of a draft guidance for 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This draft guidance provides 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draft guidance by September 1, 2009.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single copies of the draft guidance to the 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the draft guidance to the Division of 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electronic access to the draft guidance 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 (§ 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 (§ 312.2), or (3) 

under certain conditions, with the 

supervision and approval of an FDAapproved Radioactive Drugs Research 

Committee (RDRC) (§ 361.1). 

This guidance discusses the 

conditions under which research with a 

radioactive drug may be conducted 

under § 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/Guidance

ComplianceRegulatoryInformation/ 

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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