Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research, 51198-51199 [E6-14262]
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51198
Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Clinical Pharmacology Subcommittee
of the Advisory Committee for
Pharmaceutical Science; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Clinical
Pharmacology Subcommittee of the
Advisory Committee for Pharmaceutical
Science.
General Function of the
Subcommittee: To provide advice and
recommendations to the Committee for
Pharmaceutical Science on FDA’s
regulatory issues.
Date and Time: The meeting will be
held on October 18, 2006, from 8:30
a.m. to 5:30 p.m. and on October 19,
2006, from 8:30 a.m. to 1 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Mimi Phan, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD. 20857, 301–827–7001, FAX: 301–
827–6801, e-mail:
mimi.phan@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in
Washington, DC area), code
3014512539. Please call the Information
Line for up-to-date information on this
meeting. The background material will
become available no later than the day
before the meeting and will be posted
on FDA’s Web site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm under the heading
‘‘Advisory Committee for
Pharmaceutical Science (ACPS).’’ (Click
on the year 2006 and scroll down to
ACPS meetings.)
Agenda: On October 18, 2006, the
subcommittee will: (1) Receive an
update on previous Clinical
Pharmacology Subcommittee meeting
recommendations and an introduction
to three new topics of this meeting; (2)
discuss and provide comments on the
first new topic: The scope and strength
of evidence to support the inclusion of
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pharmacogenetic information on
Cytochrome P2D6 polymorphisms in a
revision of the label for tamoxifen to
improve the benefit/risk of the drug; and
(3) discuss and provide comments on
the second new topic: evaluation of
transporter-based drug interactions. On
October 19, 2006, the subcommittee will
consider the third new topic: The
impact of using prior knowledge on
drug development and regulatory
decisions. Prior knowledge of disease
change over time and covariates,
placebo variation and drug effects can
be used to make better decisions and
design more informative clinical trials.
Examples will be used to demonstrate
these principles.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the subcommittee. Written
submissions may be made to the contact
person on or before October 3, 2006.
Oral presentations from the public will
be scheduled between approximately
11:15 a.m. and 11:45 a.m. on both days.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentation should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 3, 2006.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Mimi Phan at
least 7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–14296 Filed 8–28–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory
Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The meeting of the
Psychopharmacologic Drugs Advisory
Committee scheduled for September 7,
2006, is cancelled. This amended
meeting was announced in the Federal
Register of August 17, 2006 (71 FR
47502).
FOR FURTHER INFORMATION CONTACT:
Cicely Reese, Center for Drug Evaluation
and Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7001,
FAX: 301–827–6776, e-mail:
cicely.reese@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting.
Dated: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–14293 Filed 8–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0331]
Draft Guidance for Institutional Review
Boards, Clinical Investigators, and
Sponsors; Exception from Informed
Consent Requirements for Emergency
Research
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Guidance for Institutional Review
Boards, Clinical Investigators, and
Sponsors; Exception from Informed
Consent Requirements for Emergency
Research.’’ This draft guidance, when
finalized, is intended to assist
Institutional Review Boards (IRBs),
clinical investigators, and sponsors in
the development and conduct of
emergency research.The draft guidance
E:\FR\FM\29AUN1.SGM
29AUN1
Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices
also describes the additional specific
human subject protection requirements
for emergency research. Elsewhere in
this issue of the Federal Register, FDA
is announcing a public hearing on
emergency research conducted without
informed consent under FDA
regulations.
Submit written or electronic
comments on the draft guidance by
October 30, 2006. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Policy (HF–11), Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit phone requests to 800–835–4709
or 301–827–1800. 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:
Carolyn Hommel, Good Clinical Practice
Program (HF–34), Food and Drug
Administration, 5600 Fishers Lane
Rockville, MD 20857, 301–827–3340.
SUPPLEMENTARY INFORMATION:
DATES:
jlentini on PROD1PC65 with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance entitled ‘‘Guidance for
Institutional Review Boards, Clinical
Investigators, and Sponsors; Exception
from Informed Consent Requirements
for Emergency Research.’’ This draft
guidance was developed to assist IRBs,
clinical investigators, and sponsors in
the development and conduct of
emergency research, that is, research in
emergency settings when an exception
from the informed consent requirements
is requested under FDA’s emergency
research regulation. Further, the draft
guidance describes the additional
specific human subject protection
requirements for emergency research,
such as community consultation and
public disclosure activities, the need for
the concurrence of a licensed physician,
use of data monitoring committees, use
of independent IRBs, and the
documentation of efforts to contact a
subject’s legally authorized
representative or family member
regarding the subject’s participation in
the study.
VerDate Aug<31>2005
17:07 Aug 28, 2006
Jkt 208001
In addition to the draft guidance, FDA
is holding a public hearing on
emergency research conducted without
informed consent under FDA
regulations. The public hearing is
designed to solicit the views of
individuals and groups affected by
challenges encountered in the conduct
of emergency research in the absence of
informed consent, including patient
advocacy groups, individuals who have
participated in clinical trials, IRB
members, sponsors, clinical
investigators, medical societies,
ethicists, and other interested parties.
FDA will consider comments and
suggestions received at the hearing
together with any comments received on
the draft guidance to determine whether
the current framework is adequate for
the ethical conduct of emergency
research, or whether modifications
would be appropriate.
Under the regulations in 21 CFR
50.24, and the conforming amendments
contained in 21 CFR parts 56, 312, 314,
601, 812, and 814, an exception may be
requested from the requirement to
obtain informed consent from each
subject, or the subject’s legally
authorized representative, prior to
enrollment in a clinical investigation.
The narrow exception applies to
emergency research for which, among
other things, the following conditions
exist: (1) An investigational new drug
application (IND) or investigational
device exemption application (IDE) is
required; (2) that involves human
subjects who have a life-threatening
medical condition (for which available
treatments are unproven or
unsatisfactory); (3) that involves
subjects who because of their medical
condition (e.g., unconsciousness) cannot
give informed consent; and (4) where, to
be effective, the intervention must be
administered before informed consent
from the subjects’ legally authorized
representative is feasible. Studies
involving an exception from the general
requirement of informed consent may
proceed only after a sponsor has
received prior written permission from
FDA, and the IRB has found and
documented that specific conditions
have been met.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the exception from informed consent
requirements for emergency research. 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
PO 00000
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51199
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 collections
of information in part 56 (21 CFR part
56) have been approved under OMB
control number 0910–0130, the
collections of information in part 312
(21 CFR part 312) have been approved
under OMB control number 0910–0014,
and the collections of information in
part 812 (21 CFR part 812) have been
approved under OMB control number
0910–0078. Modifications to these
approved information collection
requirements are underway or will be
made at the time that each information
collection is renewed. The agency
believes that this is appropriate because
this guidance has only a minor impact
on these existing collections of
information.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. 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: August 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–14262 Filed 8–25–06; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Pages 51198-51199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14262]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0331]
Draft Guidance for Institutional Review Boards, Clinical
Investigators, and Sponsors; Exception from Informed Consent
Requirements for Emergency Research
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Institutional
Review Boards, Clinical Investigators, and Sponsors; Exception from
Informed Consent Requirements for Emergency Research.'' This draft
guidance, when finalized, is intended to assist Institutional Review
Boards (IRBs), clinical investigators, and sponsors in the development
and conduct of emergency research.The draft guidance
[[Page 51199]]
also describes the additional specific human subject protection
requirements for emergency research. Elsewhere in this issue of the
Federal Register, FDA is announcing a public hearing on emergency
research conducted without informed consent under FDA regulations.
DATES: Submit written or electronic comments on the draft guidance by
October 30, 2006. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of the Commissioner,
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 phone requests to 800-835-4709 or 301-
827-1800. 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: Carolyn Hommel, Good Clinical Practice
Program (HF-34), Food and Drug Administration, 5600 Fishers Lane
Rockville, MD 20857, 301-827-3340.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Institutional Review Boards, Clinical Investigators, and
Sponsors; Exception from Informed Consent Requirements for Emergency
Research.'' This draft guidance was developed to assist IRBs, clinical
investigators, and sponsors in the development and conduct of emergency
research, that is, research in emergency settings when an exception
from the informed consent requirements is requested under FDA's
emergency research regulation. Further, the draft guidance describes
the additional specific human subject protection requirements for
emergency research, such as community consultation and public
disclosure activities, the need for the concurrence of a licensed
physician, use of data monitoring committees, use of independent IRBs,
and the documentation of efforts to contact a subject's legally
authorized representative or family member regarding the subject's
participation in the study.
In addition to the draft guidance, FDA is holding a public hearing
on emergency research conducted without informed consent under FDA
regulations. The public hearing is designed to solicit the views of
individuals and groups affected by challenges encountered in the
conduct of emergency research in the absence of informed consent,
including patient advocacy groups, individuals who have participated in
clinical trials, IRB members, sponsors, clinical investigators, medical
societies, ethicists, and other interested parties. FDA will consider
comments and suggestions received at the hearing together with any
comments received on the draft guidance to determine whether the
current framework is adequate for the ethical conduct of emergency
research, or whether modifications would be appropriate.
Under the regulations in 21 CFR 50.24, and the conforming
amendments contained in 21 CFR parts 56, 312, 314, 601, 812, and 814,
an exception may be requested from the requirement to obtain informed
consent from each subject, or the subject's legally authorized
representative, prior to enrollment in a clinical investigation. The
narrow exception applies to emergency research for which, among other
things, the following conditions exist: (1) An investigational new drug
application (IND) or investigational device exemption application (IDE)
is required; (2) that involves human subjects who have a life-
threatening medical condition (for which available treatments are
unproven or unsatisfactory); (3) that involves subjects who because of
their medical condition (e.g., unconsciousness) cannot give informed
consent; and (4) where, to be effective, the intervention must be
administered before informed consent from the subjects' legally
authorized representative is feasible. Studies involving an exception
from the general requirement of informed consent may proceed only after
a sponsor has received prior written permission from FDA, and the IRB
has found and documented that specific conditions have been met.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
exception from informed consent requirements for emergency research. 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. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information in part 56 (21 CFR part 56) have been
approved under OMB control number 0910-0130, the collections of
information in part 312 (21 CFR part 312) have been approved under OMB
control number 0910-0014, and the collections of information in part
812 (21 CFR part 812) have been approved under OMB control number 0910-
0078. Modifications to these approved information collection
requirements are underway or will be made at the time that each
information collection is renewed. The agency believes that this is
appropriate because this guidance has only a minor impact on these
existing collections of information.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. 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: August 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14262 Filed 8-25-06; 8:45 am]
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