[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published a document announcing the availability of a draft guidance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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