[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to FDA)--                  150               3             450  0.25 (15 minutes)...........             113            $100
 50.23(e)(3).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.


                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............           1,350             100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-P