Draft Guidance for Industry on Internal Radioactive Contamination-Development of Decorporation Agents; Availability, 7747-7748 [05-2821]
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Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices
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Dated: February 8, 2005.
Robert Sargis,
Reports Clearance, Officer.
[FR Doc. 05–2826 Filed 2–14–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0042]
Draft Guidance on the Open Public
Hearing; Food and Drug
Administration Advisory Committee
Meetings; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance
document entitled ‘‘The Open Public
Hearing; FDA Advisory Committee
Meetings.’’ This draft guidance is for
members of the public who choose to
participate in the open public hearing
(OPH) session of an FDA advisory
committee meeting. The draft guidance
is intended to answer more fully
questions about how the public may
participate at an OPH session, and it
includes topics such as meeting logistics
and administrative requirements.
DATES: Submit written or electronic
comments on this draft guidance by
June 15, 2005. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to
Linda Ann Sherman, Advisory
VerDate jul<14>2003
17:50 Feb 14, 2005
Jkt 205001
Committee Oversight and Management
Staff (HF–4), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. 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comments on the draft guidance to the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 https://www.fda.gov.dockets/
ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Linda Ann Sherman, Office of the
Commissioner (HF–4), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1220, email: disclosure@oc.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance document entitled
‘‘The Open Public Hearing; FDA
Advisory Committee Meetings.’’
Guidance documents are prepared for
FDA staff, applicants/sponsors, and the
public that describe the agency’s
interpretation of, or policy on, a
regulatory issue. Every committee
meeting includes an OPH during which
interested persons may present relevant
information or views orally or in writing
21 CFR 14.25(a). The hearing is
conducted in accordance with 21 CFR
14.29. FDA encourages the participation
from all public speakers in its
decisionmaking processes. The draft
guidance is intended to answer more
fully questions about how (including
topics such as meeting logistics and
administrative requirements) the public
may participate at an OPH session. This
includes, but is not limited to, general
members of the public; individuals or
spokespersons from the regulated
industry; consumer advocacy groups;
and professional organizations,
societies, or associations.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices (21 CFR 10.115). The
draft guidance, when finalized will
represent the agency’s current thinking
on an FDA advisory committee open
public hearing. 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 statute
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
PO 00000
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Fmt 4703
Sfmt 4703
7747
comments on the draft guidance. Two
paper 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. Received comments may be
seen 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
https://www.fda.gov/oc/advisory/
default.htm in the policy and guidance
section of FDA’s advisory committee
Intranet Web site.
Dated: February 8, 2005.
William K. Hubbard,
Associate Commissioner for Policy and
Planning.
[FR Doc. 05–2822 Filed 2–14–05; 8:45 am]
BILLING CODE 4160–01–S
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.
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
E:\FR\FM\15FEN1.SGM
15FEN1
7748
Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices
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 selfaddressed 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 https://
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. Longterm 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.
VerDate jul<14>2003
17:50 Feb 14, 2005
Jkt 205001
‘‘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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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:/
/www.fda.gov/cder/guidance/index.htm
or https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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Activities: Submission for OMB
Review; Comment Request
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and Services Administration (HRSA)
publishes abstracts of information
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Office of Management and Budget
(OMB), in compliance with the
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E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 70, Number 30 (Tuesday, February 15, 2005)]
[Notices]
[Pages 7747-7748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2821]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/cder/guidance/index.htm or https://
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
