
[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18558-18559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7846]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0464] (Formerly Docket No. 2006D-0331)


Guidance for Institutional Review Boards, Clinical Investigators, 
and Sponsors: Exception From Informed Consent for Emergency Research; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for Institutional Review 
Boards, Clinical Investigators, and Sponsors: Exception from Informed 
Consent for Emergency Research.'' This guidance is intended to assist 
institutional review boards (IRBs), clinical investigators, and 
sponsors in the development, conduct, and oversight of research 
involving FDA-regulated products (e.g., drugs, biological products, 
devices) in emergency settings when an exception from the informed 
consent requirements is requested under the Code of Federal Regulations 
(CFR). FDA determined that

[[Page 18559]]

guidance is needed in interpreting and complying with these 
regulations, particularly in the areas of planning and conducting 
community consultation and public disclosure activities, and the 
establishment of informed consent procedures to be used when feasible. 
The guidance announced in this notice finalizes the draft guidance of 
the same title, dated July 2006.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002 (1-888-463-6332 or 301-796-
3400), or the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448 (1-800-835-4709 or 301-827-1800); or the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993 (1-800-
638-2041 or 301-796-7100). Send one self-addressed adhesive label to 
assist the office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sara Goldkind, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8340.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance entitled 
``Guidance for Institutional Review Boards, Clinical Investigators, and 
Sponsors: Exception From Informed Consent for Emergency Research.'' 
This guidance is intended to assist IRBs, clinical investigators, and 
sponsors in the development, conduct, and oversight of research 
involving FDA-regulated products (e.g., drugs, biological products, 
devices) in emergency settings when an exception from the informed 
consent requirements is requested under title 21 of the CFR (21 CFR 
50.24). The exception applies to investigations to determine the safety 
and/or effectiveness of FDA-regulated products used in emergency 
settings (emergency research). These investigations involve human 
subjects who have a life-threatening medical condition (for which 
available treatments are unproven or unsatisfactory), and who, because 
of their condition (e.g., traumatic brain injury), cannot give informed 
consent. The research involves an investigational product that, to be 
effective, must be administered before informed consent from the 
subjects' legally authorized representatives can be obtained.
    In the Federal Register of August 29, 2006 (71 FR 51198), FDA 
announced the availability of the draft guidance of the same title, 
dated July 2006. The same Federal Register (71 FR 51143) announced a 
public hearing, held on October 11, 2006, on emergency research 
conducted without informed consent under FDA's emergency research 
regulations.
    FDA received numerous comments on the draft guidance. All comments 
received during the comment period, questions received by Agency staff 
related to implementation of the regulations, and information presented 
at the public hearing have been carefully reviewed and, where 
appropriate, incorporated into the guidance. A summary of changes 
includes the following: (1) Additional discussion of the goals and 
purpose of community consultation and public disclosure, information 
that should be included, and how community consultation and public 
disclosure activities may be implemented; (2) clarification of 
``unproven'' and ``unsatisfactory'' with respect to available therapy; 
and (3) discussion of trial design issues (e.g., study endpoints, 
therapeutic window. This guidance incorporates comments received on 
earlier drafts of the guidance document, questions received by Agency 
staff related to implementation of the regulations, and information 
presented at the October 11, 2006, public meeting on emergency research 
studies.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. 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 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 21 CFR part 56 have been approved under 
OMB control number 0910-0130, the collections of information in 21 CFR 
part 312 have been approved under OMB control number 0910-0014, and the 
collections of information in 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: March 29, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7846 Filed 4-1-11; 8:45 am]
BILLING CODE 4160-01-P


