[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Pages 19915-19917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08006]
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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
[[Page 19916]]
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 the collection
of information related to the use of investigational in vitro
diagnostic devices to identify chemical, biological, radiological, or
nuclear agents without informed consent in certain circumstances.
DATES: Submit either electronic or written comments on the collection
of information by June 9, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [email protected].
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.
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 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 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
[[Page 19917]]
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.
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 operating and
Activity/21 CFR Section respondents responses per responses Average burden per response Total hours maintenance
respondent costs
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Written certification (sent to FDA)-- 150 3 450 0.25 (15 minutes)........... 113 $100
50.23(e)(3).
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\1\ There are no capital costs associated with this collection of information.
Table 2--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 disclosures disclosures per disclosure Total hours maintenance
per respondent costs
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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
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Total............................................... .............. .............. .............. .............. 1,350 100
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\1\ There are no capital costs associated with this collection of information.
Dated: April 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08006 Filed 4-9-14; 8:45 am]
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