Document ID: FDA-2010-N-0062-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Medical Devices;
Exception From General Requirements for Informed Consent
Posted Date: 2017-08-22T04:00Z

[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39792-39793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17702]

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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; 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 or the Agency) 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 
September 21, 2017.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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.

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 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.
    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

[[Page 39793]]

naturally occurring cases of diseases or conditions that are identified 
in the Centers for Disease Control and Prevention'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. We 
estimate the operating and maintenance cost of $200 for copying and 
mailing the information to FDA.
    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.
    In the Federal Register of April 18, 2017 (82 FR 18294), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 per                     operating and
              21 CFR section                 respondents     responses per      responses               response            Total hours    maintenance
                                                               respondent                                                                     costs
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Written certification (sent to FDA)--                 150                3              450   0.25 (15 minutes)..........          113             $200
 50.23(e)(3).
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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\
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                                                     Number of
                                     Number of      disclosures    Total annual       Average
           21 CFR Part              respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
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Written certification (sent to               150               3             450               2             900
 IRB)--50.23(e)(1) and (2)......
Informed consent information--               150               3             450               1             450
 50.23(e)(4)....................
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    Total.......................  ..............  ..............  ..............  ..............           1,350
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17702 Filed 8-21-17; 8:45 am]
 BILLING CODE 4164-01-P