Document ID: FDA-2010-N-0062-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Exception from General Requirements for Informed Consent
Posted Date: 2010-05-06T04:00Z

[Federal Register: May 6, 2010 (Volume 75, Number 87)]
[Notices]               
[Page 24960-24961]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my10-71]                         

[[Page 24960]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0062]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Exception From 
General Requirements for Informed Consent

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 7, 
2010.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0586. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Devices; Exception From General Requirements for Informed 
Consent--21 CFR 50.23 (OMB Control Number 0910-0586)--Extension

Background Information
    In the Federal Register of June 7, 2006 (71 FR 32827), FDA issued 
an interim final rule (hereinafter referred to as the June 7, 2006, 
interim final rule) to amend its regulations to establish a new 
exception from the general requirements for informed consent, to permit 
the use of investigational in vitro diagnostic devices to identify 
chemical, biological, radiological, or nuclear agents without informed 
consent in certain circumstances. The agency took this action because 
it was concerned that, during a potential terrorism event or other 
potential public health emergency, delaying the testing of specimens to 
obtain informed consent may threaten the life of the subject. In many 
instances, there may also be others who have been exposed to, or who 
may be at risk of exposure to, a dangerous chemical, biological, 
radiological, or nuclear agent, thus necessitating identification of 
the agent as soon as possible. FDA created this exception to help 
ensure that individuals who may have been exposed to a chemical, 
biological, radiological, or nuclear agent are able to benefit from the 
timely use of the most appropriate diagnostic devices, including those 
that are investigational.
     Section 50.23(e)(1) (21 CFR 50.23(e)(1)) provides an exception to 
the general rule that informed consent is required for the use of an 
investigational in vitro diagnostic device. This exception will apply 
to those situations in which the in vitro investigational diagnostic 
device is used to prepare for and respond to a chemical, biological, 
radiological, or nuclear terrorism event or other public health 
emergency, if the investigator and an independent licensed physician 
make the determination and later certify in writing that: (1) There is 
a life-threatening situation necessitating the use of the 
investigational device; (2) obtaining informed consent from the subject 
is not feasible because there was no way to predict the need to use the 
investigational device when the specimen was collected and there is not 
sufficient time to obtain consent from the subject or the subject's 
legally authorized representative; and (3) no satisfactory alternative 
device is available. Under the June 7, 2006, interim final rule, these 
determinations are made before the device is used, and the written 
certifications are made within 5 working days after the use of the 
device. If use of the device is necessary to preserve the life of the 
subject and there is not sufficient time to obtain the determination of 
the independent licensed physician in advance of using the 
investigational device, Sec.  50.23(e)(2) provides that the 
certifications must be made within 5 working days of use of the device. 
In either case, the certifications are submitted to the Institutional 
Review Board (IRB) within 5 working days of the use of the device.
    Section 50.23(e)(4) provides that an investigator must disclose the 
investigational status of the device and what is known about the 
performance characteristics of the device at the time test results are 
reported to the subject's health care provider and public health 
authorities, as applicable. Under the June 7, 2006, interim final rule, 
the investigator provides the IRB with the information required by 
Sec.  50.25 (21 CFR 50.25) (except for the information described in 
Sec.  50.25(a)(8)) and the procedures that will be used to provide this 
information to each subject or the subject's legally authorized 
representative.
    From its knowledge of the industry, FDA estimates that there are 
approximately 150 laboratories that could perform testing that uses 
investigational in vitro diagnostic devices to identify chemical, 
biological, radiological, or nuclear agents. FDA estimates that in the 
United States each year there are approximately 450 naturally occurring 
cases of diseases or conditions that are identified in the Centers for 
Disease Control's list of category `A' biological threat agents. The 
number of cases that would result from a terrorist event or other 
public health emergency is uncertain. Based on its knowledge of similar 
types of submissions, FDA estimates that it will take about 2 hours to 
prepare each certification.
    Based on its knowledge of similar types of submissions, FDA 
estimates that it will take about 1 hour to prepare a report disclosing 
the investigational status of the in vitro diagnostic device and what 
is known about the performance characteristics of the device and submit 
it to the health care provider and, where appropriate, to public health 
authorities.
    The June 7, 2006, interim final rule refers to previously approved 
collections of information found in FDA regulations. These collections 
of information are subject to review by OMB under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in Sec.  50.25 have been approved under 0910-0130.
    In the Federal Register of February 18, 2010 (75 FR 7278), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates this burden of the collection of information as 
follows:

[[Page 24961]]

                                                 Table 1.--Estimated Average Annual Reporting Burden\1\
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                                           No. of        Annual Frequency     Total Annual       Hours per                          Total Operating &
           21 CFR Section               Respondents        of Responses        Responses         Response        Total Hours        Maintenance Costs
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50.23(e)(1) and (e)(2)                             150                  3                450               2                900                    $0.00
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50.23(e)(4)                                        150                  3                450               1                450                  $100.00
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Total                                                                                                                     1,350                  $100.00
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    Dated: April 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10656 Filed 5-5-10; 8:45 am]
BILLING CODE 4160-01-S