[Federal Register Volume 68, Number 96 (Monday, May 19, 2003)]
[Proposed Rules]
[Pages 27008-27009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 315 and 601

[Docket No. 98D-0785]


Draft Guidances for Industry on Medical Imaging Drug and 
Biological Products; 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 three draft guidances for industry on ``Developing 
Medical Imaging Drug and Biological Products.'' These draft guidances 
are intended to assist developers of medical imaging drug and 
biological products (medical imaging agents) in planning and 
coordinating their clinical investigations and preparing and submitting 
investigational new drug applications (INDs), new drug applications 
(NDAs), biologics license applications (BLAs), abbreviated new drug 
applications (ANDAs), and supplements to NDAs or BLAs. The draft 
guidances provide information on how FDA will interpret and apply 
certain provisions in the agency's regulations on in vivo 
radiopharmaceuticals used for diagnosis and monitoring of diseases and 
conditions.

DATES: Submit written or electronic comments on the draft guidances by 
June 18, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidances to the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Office of Communications, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist either office in 
processing your request. Submit written comments on the draft guidances 
to the Dockets Management Branch (HFA-305), Food and Drug

[[Page 27009]]

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidances.

FOR FURTHER INFORMATION CONTACT: Kyong Kang, Center for Drug Evaluation 
and Research (HFD-160), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-7510, or George Q. Mills, Center for 
Biologics Evaluation and Research (HFM-573), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
5097.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 14, 1998 (63 FR 55067), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Developing Medical Imaging Drugs and Biologics'' 
(the medical imaging draft guidance). In a document published in the 
Federal Register of January 5, 1999 (64 FR 457), FDA reopened the 
comment period on the medical imaging draft guidance until February 12, 
1999. In a document published in the Federal Register of February 16, 
1999 (64 FR 7561), FDA extended the comment period until April 14, 
1999.
    FDA received numerous written comments on the medical imaging draft 
guidance. In addition, the agency held public meetings on January 25 
and March 26, 1999, to discuss various issues concerning the medical 
imaging draft guidance. In the Federal Register of July 31, 2000 (65 FR 
46674), the agency published a notice announcing the availability of a 
revised draft guidance.
    After considering the comments that FDA received on the revised 
draft guidance, the agency has decided to issue the guidance again as a 
draft for comment. The agency has divided the draft guidance into three 
parts to make it more user-friendly. These three draft guidances are 
intended to assist developers of medical imaging agents in planning and 
coordinating their clinical investigations and preparing and submitting 
INDs, NDAs, BLAs, ANDAs, and supplements to NDAs or BLAs.
    Part 1 of ``Medical Imaging Drug and Biological Products,'' 
entitled ``Conducting Safety Assessments,'' discusses how to conduct 
safety assessments of medical imaging agents. Part 2, entitled 
``Clinical Indications,'' discusses how clinical development programs 
for medical imaging agents can be tailored to reflect the use of these 
agents for diagnosis and monitoring of diseases and conditions. Part 3, 
entitled ``Design, Analysis, and Interpretation of Clinical Studies,'' 
discusses how to design a clinical development program for a medical 
imaging agent, including selecting subjects, and how to acquire, 
analyze, and interpret medical imaging data. Collectively, once 
finalized these draft guidances will provide information on how FDA 
will interpret and apply certain provisions in the final rule, 
published in the Federal Register of May 17, 1999 (64 FR 26657), on the 
evaluation and approval of in vivo radiopharmaceuticals used in 
diagnosis and monitoring.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidances represent 
the agency's current thinking on different aspects of the development 
of medical imaging agents. They do not create or confer any rights for 
or on any person and do 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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidances. 
Submit a single copy of electronic comments or two paper copies of any 
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. The guidances and received comments 
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

IV. The Paperwork Reduction Act of 1995

    These guidances contain information collection provisions that 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 
guidances would not impose any additional reporting burden because 
information on the safety and effectiveness of medical imaging agents 
in applications for marketing approval and INDs is already required by 
existing regulations. In fact, clarification by the guidances of FDA's 
standards for evaluation of medical imaging agents is expected to 
reduce the overall burden of information collection. FDA received no 
comments on the analysis of information collection burdens stated in 
the notice of availability of the original draft guidance published in 
the Federal Register on October 14, 1998 (63 FR 55067). In the Federal 
Register of July 31, 2000 (65 FR 46674), the agency requested comments 
on the revised proposed collections of information. No comments were 
received.

    Dated: May 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12370 Filed 5-16-03; 8:45 am]
BILLING CODE 4160-01-S