Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent, 18294-18296 [2017-07768]
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Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
purposes of surveillance, mitigation,
work planning, and supporting the
animal food standard requirements.
PETNet and LivestockNet reports
share the following common data
elements, the majority of which are drop
down menu choices: Product details
(product name, lot code, product form,
and the manufacturer or distributor/
packer (if known)), the species affected,
number of animals exposed to the
product, number of animals affected,
body systems affected, product
problem/defect, date of onset or the date
product problem was detected, the State
where the incident occurred, the origin
of the information, whether there are
supporting laboratory results, and
contact information for the reporting
member (i.e., name, telephone number
will be captured automatically when
member logs in to the system). For the
LivestockNet report, additional data
elements specific to livestock animals
will be captured: Product details
(indication of whether the product is a
medicated feed under 21 CFR
558.3(b)(8), product packaging, and
intended purpose of the product), class
of the animal species affected, and
production loss. For PETNet reports, the
only additional data field is the animal
life stage. The proposed SampleNet
reports will have the following data
elements, many of which are drop down
menu choices: Product information
(product name, lot code, guarantor
information, date and location of sample
collection, and product description);
laboratory information (sample
identification number, the reason for
testing, whether the food was reported
to the Reportable Food Registry, who
performed the analysis); and results
information (analyte, test method,
analytical results, whether the results
contradict a label claim or guarantee,
and whether action was taken as a result
of the sample analysis).
Description of Respondents:
Respondents to the collection of
information are Federal, State, and
Territorial regulatory and public health
Agency employees with membership
access to the Animal Feed Network.
In the Federal Register of March 15,
2016 (81 FR 13794), 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
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
PETNet .................................................................................
LivestockNet .........................................................................
SampleNet ...........................................................................
20
20
20
5
5
5
100
100
100
* 0.25
* 0.25
* 0.25
25
25
25
Total ..............................................................................
75
........................
........................
........................
........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* 15 minutes.
Our estimate is based on our
experience with the tracking network
over the past 3 years. We estimate that
we will receive an average of 5
submissions from 20 respondents for
each type of report, and that it will take
15 minutes (0.25 hour) per response.
Dated: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–07769 Filed 4–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2010–N–0062]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Exception From General Requirements
for Informed Consent
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
16:55 Apr 17, 2017
Jkt 241001
Submit either electronic or
written comments on the collection of
information by June 19, 2017.
ADDRESSES: You may submit comments
as follows:
DATES:
Food and Drug Administration
AGENCY:
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.
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
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18APN1.SGM
18APN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
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.
VerDate Sep<11>2014
16:55 Apr 17, 2017
Jkt 241001
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.
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.
SUPPLEMENTARY INFORMATION:
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,
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Fmt 4703
Sfmt 4703
18295
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 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
E:\FR\FM\18APN1.SGM
18APN1
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Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
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
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
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total operating
and
maintenance
costs
Written certification (sent to FDA)—
50.23(e)(3) ............................................
150
3
450
0.25
113
$200
Average
burden per
disclosure
Total hours
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
Written certification (sent to IRB)—50.23(e)(1) and (e)(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: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
provide advice and recommendations to
the Agency on FDA’s regulatory issues.
The meeting will be open to the public.
FDA is establishing a docket for public
comment on this document.
[FR Doc. 2017–07768 Filed 4–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2093]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
sradovich on DSK3GMQ082PROD with NOTICES
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Oncologic Drugs
Advisory Committee (ODAC). The
general function of the committee is to
SUMMARY:
VerDate Sep<11>2014
16:55 Apr 17, 2017
The meeting will be held on May
24, 2017, from 8 a.m. to 5 p.m. The
docket number is FDA–2017–N–1063.
The docket will close on May 23, 2017.
Comments received on or before May
10, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
DATES:
Jkt 241001
FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. You may submit
comments as follows:
ADDRESSES:
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\18APN1.SGM
18APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to FDA)--50.23(e)(3).. 150 3 450 0.25 113 $200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Part Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
