Document ID: FDA-2010-N-0062-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Exception From
General Requirements for Informed Consent
Posted Date: 2014-07-16T04:00Z

[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Pages 41580-41581]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16672]

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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 August 
15, 2014.

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 emailed 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

Exception From General Requirements for Informed Consent--(OMB Control 
Number 0910-0586)--Extension

    In the Federal Register of June 7, 2006 (71 FR 32827), FDA issued 
an 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 applies 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

[[Page 41581]]

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 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) and, under Sec.  
50.23(e)(3) (76 FR 36989, June 24, 2011), to FDA 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 Sec.  50.23(e)(4), 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 April 10, 2014 (79 FR 19915), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                 Activity/21 CFR section                    respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to FDA)--50.23(e)(3)........             150               3             450            0.25             113            $100
                                                                                                            (15 minutes)
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\1\ There are no capital costs associated with this collection of information.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                  Activity/CFR section                      respondents     disclosures     disclosures   per disclosure    Total hours     maintenance
                                                                          per respondent                                                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to IRB)--50.23(e)(1) and                 150               3             450               2             900              $0
 (e)(2).................................................
Informed consent information--50.23(e)(4)...............             150               3             450               1             450             100
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............           1,350             100
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\1\ There are no capital costs associated with this collection of information.

    Dated: July 10, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16672 Filed 7-15-14; 8:45 am]
BILLING CODE 4164-01-P