[Federal Register Volume 72, Number 32 (Friday, February 16, 2007)]
[Notices]
[Pages 7662-7664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0355]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
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 March 
19, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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--(OMB Control Number 0910-0586)--Extension

    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 is 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.
     FDA requested public comment on the information collection 
requirements in the June 7, 2006, interim final rule.
    The collection of information requirements for the June 7, 2006, 
interim final rule were approved under the emergency processing 
provisions of the Paperwork Reduction Act (PRA), and assigned OMB 
control 0910-0586. With this approval, OMB informed the agency that the 
preamble and solicitation of public comment by the June 7, 2006, 
interim final rule would serve as a 60-day notice for the 3 year 
extension of this collection of information. In addition, OMB also 
requested that FDA, in submitting its extension request, summarize 
comments received in response to the 60-day notice, describe how the 
agency will address substantive issues raised by the commenters, and 
provide an update on the status of the final rule. FDA is responding to 
OMB's requests below:
    FDA received 10 comments on the interim final rule, three of which 
related to the information collection requirements. The other comments 
on the rule will be addressed in the preamble to the final rule. FDA 
expects to publish the final rule in 2009.
    One comment suggested that the requirement that a laboratory 
certify to an institutional review board (IRB) that the testing was 
done in a life-threatening situation and that it was not feasible to 
obtain consent serves no purpose, since these issues have already been 
pre-determined by FDA and provide the basis for exemption. FDA 
disagrees. The certification requirement ensures that the laboratory 
documents for the IRB that it is complying with the requirements of the 
regulation. The comment also stated that the concurrence of an 
independent physician, which will occur post-

[[Page 7663]]

testing, adds no value to the certification. FDA also disagrees with 
this point: the information is necessary because it provides 
confirmation from an independent source that the regulations are being 
followed. This provision is found in other FDA regulations and is an 
important additional protection to the subjects in these trials. 
Lastly, the comment stated that providing the subject with consent 
information is of no value because at that time the subject can not 
choose whether to have the specimen tested since the test has already 
been performed. According to the comment, sending the subject a copy of 
the notice to the IRB should be sufficient. While the comment correctly 
states that subjects can not give informed consent after the test has 
been performed, providing subjects with this information demonstrates 
respect for the individual (one of the core principles in the Belmont 
Report and an important component of human subject protection) by fully 
informing them of the circumstances of the trial. It would not be 
appropriate to send the subject the information provided to the IRB 
because the type of information the IRB usually receives would not 
fully inform the subject about the trial; the IRB document is typically 
written in technical language that is likely to be less understandable 
to subjects.
    Another comment requested that Sec.  50.32(e)(4) explicitly require 
investigators to notify the jurisdictional public health authority upon 
suspicion of need for testing for a chemical, biological, radiological, 
or nuclear agent with the investigational device; and further that the 
language should reinforce that investigators must provide test results 
to the jurisdictional public health authority in accordance with State 
and/or Federal law. This comment falls out of the scope of the 
questions posed in the Federal Register notice and this type of 
reporting to public health authorities is beyond FDA's purview.
    The last comment encouraged FDA to consider increasing the length 
of time in which the written certification for the exception is 
required to be submitted, with the goal of easing the reporting burden. 
The certification is required to be submitted within 5 working days of 
the use of the investigational device. FDA believes that the 5-day 
reporting period is important because it helps ensure that IRBs will 
receive timely notice of instances in which this rule is used. In 
addition, the 5-day reporting period appears in other FDA human subject 
protection regulations that address other exceptions to the general 
requirement of obtaining informed consent and the agency believes that 
it is important to maintain consistency within its regulations wherever 
possible.
    The likely respondents for this collection of information are 
clinical laboratories and physicians.
    FDA estimates the burden of the collection of information as 
follows:

                             Table 1.--Estimated Average Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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50.23(e)(1) and                  150                  3                450                  2                900
 (e)(2)
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50.23(e)(4)                      150                  3                450                  1                450
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Total Hours                                                                                               1,350
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  Information.

    FDA is adding Sec.  50.23(e)(1) (21 CFR 50.23(e)(1)) to provide 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 IRB within 5 
working days of the use of the device.
    From its knowledge of the industry, FDA estimates that there are 
approximately 150 laboratories that could perform this type of testing. 
FDA estimates that in the United States each year there are 
approximately 450 naturally occurring cases of diseases or conditions 
that are identified in CDC'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.
    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. Based on its knowledge of similar types of submissions, 
FDA estimates that it will take about 1 hour to prepare this 
information and submit it to the health care provider and, where 
appropriate, to public health authorities.


[[Page 7664]]


    Dated: February 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2794 Filed 2-15-07; 8:45 am]
BILLING CODE 4160-01-S