Document ID: FDA-2010-N-0062-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Exception From General Requirements for Informed Consent
Posted Date: 2010-02-18T05:00Z

[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]               
[Page 7278-7279]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe10-38]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on 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.

DATES:  Submit written or electronic comments on the collection of 
information by April 19, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 7279]]

Medical Devices; Exception From General Requirements for Informed 
Consent--21 CFR 50.23 (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 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.
    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  of     Total Annual        Hours per
                    21 CFR Section                         Respondents           Responses           Responses           response         Total hours
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50.23(e)(1)(2)                                                        150                     3                450                  2                900
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50.23(e)(4)                                                           150                     3                450                  1                450
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                  Total                                                                                                                             1350
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information

    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 Centers for 
Disease Controls'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.
    This interim final rule 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 50.25 have been 
approved under 0910-0130.

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3025 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S