Document ID: FDA-2010-N-0062-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent
Posted Date: 2017-04-18T04:00Z

[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18294-18296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07768]

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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; 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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 the information collection regarding 
exception from the general requirements for informed consent.

DATES: Submit either electronic or written comments on the collection 
of information by June 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your

[[Page 18295]]

comment, as well as any attachments, except for information submitted, 
marked and identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0062 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Devices; Exception From 
General Requirements for Informed Consent.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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

[[Page 18296]]

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                        Number of                                                        Total operating
                  21 CFR Section                       Number of      responses per     Total annual    Average burden    Total hours    and maintenance
                                                      respondents       respondent       responses       per response                         costs
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Written certification (sent to FDA)--50.23(e)(3)..             150                3              450             0.25              113             $200
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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                        Average
           21 CFR Part               Number of      disclosures    Total annual     burden per      Total hours
                                    respondents   per respondent    disclosures     disclosure
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Written certification (sent to               150               3             450               2             900
 IRB)--50.23(e)(1) and (e)(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: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07768 Filed 4-17-17; 8:45 am]
 BILLING CODE 4164-01-P