[Federal Register: February 15, 2005 (Volume 70, Number 30)]
[Notices]
[Page 7747-7748]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe05-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0033]
Draft Guidance for Industry on Internal Radioactive
Contamination--Development of Decorporation Agents; 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availability of a draft guidance for industry entitled ``Internal
Radioactive Contamination--Development of Decorporation Agents.'' This
draft document provides guidance to industry on the development of
decorporation agents for the treatment of internal radioactive
contamination when evidence is needed to demonstrate the effectiveness
of the agents, but human efficacy studies are unethical or infeasible.
In such instances, the Animal Efficacy Rule may be invoked to approve
new medical products not previously marketed or new indications for
previously marketed products. Specifically, this draft guidance
addresses chemistry, manufacturing and controls (CMC) information;
animal efficacy, safety pharmacology, and toxicology studies; clinical
pharmacology, biopharmaceutics, and human safety studies; and
postapproval commitments.
DATES: Submit written or electronic comments on the draft guidance by
May
[[Page 7748]]
16, 2005. General comments on agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. 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on the draft guidance to the Division of Dockets Management (HFA-305),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://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 guidance document.
FOR FURTHER INFORMATION CONTACT: Patricia A. Stewart, Center for Drug
Evaluation and Research (HFD-160), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7510.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Internal Radioactive Contamination--Development of
Decorporation Agents.'' This draft guidance is being issued to
facilitate the development of new decorporation agents or new uses of
previously marketed medical products for the treatment of internal
radioactive contamination.
Internal radioactive contamination can arise from accidents
involving nuclear reactors, industrial sources, or medical sources. The
potential for such accidents has been present for many years. Recent
events also have highlighted the potential for nonaccidental
radioactive contamination as a result of malicious, criminal, or
terrorist actions. Internal contamination occurs when radioactive
material is ingested, inhaled, or absorbed from a contaminated wound.
As long as these radioactive contaminants remain in the body, they may
pose significant health risks. Long-term health concerns include the
potential for the development of cancers of the lung, liver, thyroid,
stomach, and bone and, when a radioactive contaminant is inhaled, for
the development of fibrotic changes in the lung that may lead to
restrictive lung disease. The only effective method of reducing these
risks is removal of the radioactive contaminants from the body.
``Decorporation agents'' refer to medical products that increase
the rate of elimination or excretion of inhaled, ingested, or absorbed
radioactive contaminants. The effectiveness of most decorporation
agents for the treatment of internal radioactive contamination cannot
be tested in humans because the occurrence of accidental or
nonaccidental radioactive contamination is rare, and it would be
unethical to deliberately contaminate human volunteers with potentially
harmful amounts of radioactive materials for investigational purposes.
FDA is issuing this draft guidance to facilitate the development of
new decorporation agents or new indications for previously marketed
medical products that may be eligible for approval under the Animal
Efficacy Rule (21 CFR part 314, subpart I and 21 CFR part 601, subpart
H). As set forth in this rule, under certain circumstances animal
studies can be relied on to provide substantial evidence of
effectiveness of a product. Evaluation of the product for safety in
humans is still required, and cannot be addressed by animal studies
alone. The adequacy of human safety data will need to be assessed from
clinical pharmacology and safety studies conducted in humans. This
draft guidance addresses the design and conduct of the requisite CMC,
animal efficacy, safety pharmacology, toxicology, clinical
pharmacology, biopharmaceutics, and human safety studies needed to
support approval of new decorporation agents or new uses of previously
marketed medical products for the treatment of internal radioactive
contamination.
In addition, approval under the Animal Efficacy Rule is subject to
certain postapproval commitments, including submission of a plan for
conducting postmarketing studies that would be feasible should an
accidental or intentional release of radiation occur, postmarketing
restrictions to ensure safe use, if deemed necessary, and product
labeling information intended for the patient advising that, among
other things, the product's approval was based on effectiveness studies
conducted in animals alone. This draft guidance addresses the
postapproval commitments that would be needed for approval of a new
decorporation agent or for a new indication for a previously approved
agent under the Animal Efficacy Rule.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the agency's current thinking on the development of decorporation
agents for the treatment of internal radioactive contamination. 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance 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
draft guidance 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 document 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.
Dated: February 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2821 Filed 2-14-05; 8:45 am]
BILLING CODE 4160-01-S