[Federal Register: June 22, 2004 (Volume 69, Number 119)]
[Notices]               
[Page 34683-34684]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn04-97]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-0785]

 
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 guidances for industry on ``Developing Medical 
Imaging Drug and Biological Products.'' These 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

[[Page 34684]]

investigational new drug applications (INDs), new drug applications 
(NDAs), biologics license applications (BLAs), abbreviated new drug 
applications (ANDAs), and supplements to NDAs or BLAs.

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

ADDRESSES: Submit written requests for single copies of the guidances 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your request. Submit written 
comments on the guidances 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for 

electronic access to the guidances.

FOR FURTHER INFORMATION CONTACT:
    Sally Loewke, Center for Drug Evaluation and Research (HFD-160), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-7510, or
    Kathleen Swisher, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 14, 1998 (63 FR 55067), FDA 
published a document announcing the availability of a draft guidance 
for industry entitled ``Developing Medical Imaging Drugs and 
Biologics.'' In a document published in the Federal Register of January 
5, 1999 (64 FR 457), FDA reopened the comment period on the 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 draft 
guidance. In the Federal Register of July 31, 2000 (65 FR 46674), the 
agency published a document announcing the availability of a revised 
draft guidance.
    After considering the comments that FDA received on the revised 
draft guidance, the agency decided to revise the draft guidance, divide 
it into three parts to make it more user-friendly, and issue the three 
parts as drafts for comment. In the Federal Register of May 19, 2003 
(68 FR 27008), FDA published a document announcing the availability of 
the three parts.
    Part 1 of ``Medical Imaging Drug and Biological Products,'' 
entitled ``Conducting Safety Assessments,'' provides recommendations on 
conducting safety assessments of medical imaging agents. Part 2, 
``Clinical Indications,'' provides recommendations on tailoring 
clinical development programs for medical imaging agents to reflect the 
use of these agents for diagnosis and monitoring of diseases and 
conditions. Part 3, ``Design, Analysis, and Interpretation of Clinical 
Studies,'' provides recommendations on designing a clinical development 
program for a medical imaging agent, including selecting subjects, and 
on acquiring, analyzing, and interpreting medical imaging data. 
Collectively, these guidances provide information and recommendations 
on how to develop all types of medical imaging agents and how to comply 
with 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. 
Having reviewed the comments that FDA received on each of the three 
parts, and having made appropriate changes, the agency is issuing final 
versions of these guidances.
    These 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 Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidances at any 
time. Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidances and received comments are available for public examination 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 documents at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 the 
submission of 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 announcement 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: June 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14077 Filed 6-21-04; 12:56 pm]

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