Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent, 39792-39793 [2017-17702]
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Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
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for each presentation may be limited. If
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notify interested persons regarding their
request to speak by August 28, 2017.
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the Federal Advisory Committee Act (5
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Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17726 Filed 8–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[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.
The Food and Drug
Administration (FDA or the Agency) is
announcing that a proposed collection
SUMMARY:
VerDate Sep<11>2014
18:00 Aug 21, 2017
Jkt 241001
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.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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 lifethreatening 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, § 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 § 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
§ 50.23(e)(4), the investigator provides
the IRB with the information required
by § 50.25 (21 CFR 50.25) (except for the
information described in § 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
E:\FR\FM\22AUN1.SGM
22AUN1
39793
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
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
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:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Total
operating and
maintenance
costs
150
21 CFR section
3
450
0.25 (15 minutes) ...............
113
$200
Written certification (sent to
FDA)—50.23(e)(3).
1 There
are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR Part
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Written certification (sent to IRB)—50.23(e)(1) and (2) ......
Informed consent information—50.23(e)(4) .........................
150
150
3
3
450
450
2
1
900
450
Total ..............................................................................
........................
........................
........................
........................
1,350
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.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by September
21, 2017.
DATES:
[FR Doc. 2017–17702 Filed 8–21–17; 8:45 am]
BILLING CODE 4164–01–P
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 0910–0016 and
title ‘‘Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), Submission of Information to
a Master File in Support of Petitions;
and Electronic Submission Using Food
and Drug Administration Form 3503.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0258]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling),
Submission of Information to a Master
File in Support of Petitions; and
Electronic Submission Using Food and
Drug Administration Form 3503
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Sep<11>2014
21:20 Aug 21, 2017
Ila
Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Notice.
Jkt 241001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), Submission of Information to
a Master File in Support of Petitions;
and Electronic Submission Using Food
and Drug Administration Form 3503—
21 CFR 70.25, 71.1, and 171.1, and 21
CFR parts 172, 173, 179, and 180; OMB
Control Number 0910–0016—Extension.
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe,
unless: (1) The additive and its use, or
intended use, are in conformity with a
regulation issued under section 409 of
the FD&C Act that describes the
condition(s) under which the additive
may be safely used; (2) the additive and
its use, or intended use, conform to the
terms of an exemption for
investigational use; or (3) a food contact
notification submitted under section
409(h) is effective. Food additive
petitions (FAPs) are submitted by
individuals or companies to obtain
approval of a new food additive or to
amend the conditions of use permitted
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to FDA)-- 150 3 450 0.25 (15 minutes).......... 113 $200
50.23(e)(3).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
21 CFR Part respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
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)....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,350
----------------------------------------------------------------------------------------------------------------
\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
