Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exception From General Requirements for Informed Consent, 41580-41581 [2014-16672]
Download as PDF
<![CDATA[
41580
Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Notices
and that the total average burden hours
for a reconsideration request will be 24
hours. We estimate that we will receive
1 request annually for an appeal of a
user fee waiver determination, and that
the time needed to prepare an appeal
would be approximately 12 hours. We
have included in this estimate both the
time needed to prepare the request for
appeal and the time needed to create
and send a copy of the request for an
appeal to the Associate Director for
Policy at the Center for Drug Evaluation
and Research.
The burden for filling out and
submitting Form FDA 3397
(Prescription Drug User Fee Coversheet)
has not been included in the burden
analysis, because that information
collection is already approved under
OMB control number 0910–0297. The
collections of information associated
with a new drug application or biologics
license application have been approved
under OMB control numbers 0910–0001
and 0910–0338, respectively.
We have included in the burden
estimate the preparation and submission
of application fee waivers for small
businesses, because small businesses
requesting a waiver must submit
documentation to FDA on the number of
their employees and must include the
information that the application is the
first human drug application, within the
meaning of the FD&C Act, to be
submitted to the Agency for approval.
Because the Small Business
Administration (SBA) makes the size
determinations for FDA, small
businesses must also submit
information to the SBA. The submission
of information to SBA is already
approved under OMB control number
3245–0101.
In the Federal Register of March 4,
2014 (79 FR 12201), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comments. However, these comments
did not address the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
User fee waivers, reductions, and refunds for drug and
biological products
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
FD&C Act sections 735 and 736 .......................................
Reconsideration Requests .................................................
Appeal Requests ................................................................
100
3
1
1.2
1
1
120
3
1
16
24
12
1,920
72
12
Total ............................................................................
........................
..........................
........................
........................
2,004
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 11, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
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 oiral
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.
ADDRESSES:
[FR Doc. 2014–16709 Filed 7–15–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0062]
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exception From
General Requirements for Informed
Consent
SUPPLEMENTARY INFORMATION:
AGENCY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 August 15,
2014.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:58 Jul 15, 2014
Jkt 232001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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
E:\FR\FM\16JYN1.SGM
16JYN1
41581
Federal Register / Vol. 79, No. 136 / Wednesday, July 16, 2014 / Notices
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.
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
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 § 50.25
have been approved under 0910–0130.
In the Federal Register of April 10,
2014 (79 FR 19915), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/21 CFR section
Number of
respondents
Written certification (sent to FDA)—
50.23(e)(3) ............................................
1 There
Number of
responses per
respondent
150
Total annual
responses
3
450
Average
burden per
response
Total hours
0.25
(15 minutes)
113
Total
operating and
maintenance
costs
$100
are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity/CFR section
Written certification (sent to IRB)—
50.23(e)(1) and (e)(2) ...........................
Informed
consent
information—
50.23(e)(4) ............................................
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
150
3
450
2
900
$0
150
3
450
1
450
100
1,350
100
Total ..................................................
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs associated with this collection of information.
Dated: July 10, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–16672 Filed 7–15–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Mar<15>2010
17:58 Jul 15, 2014
Jkt 232001
Total
operating and
maintenance
costs
PO 00000
Frm 00051
Fmt 4703
Sfmt 9990
E:\FR\FM\16JYN1.SGM
16JYN1
]]>Agencies
[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Pages 41580-41581]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16672]
-----------------------------------------------------------------------
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; Exception From
General Requirements for Informed Consent
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 August
15, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
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
[[Page 41581]]
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 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.
In the Federal Register of April 10, 2014 (79 FR 19915), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
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 operating and
Activity/21 CFR section respondents responses per responses per response Total hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to FDA)--50.23(e)(3)........ 150 3 450 0.25 113 $100
(15 minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden operating and
Activity/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: July 10, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16672 Filed 7-15-14; 8:45 am]
BILLING CODE 4164-01-P
