Agency Information Collection Activities; Proposed Collection; Comment Request; Exception From General Requirements for Informed Consent, 7278-7279 [2010-3025]
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7278
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
Guidance for Industry on ‘‘How to
Submit a Protocol Without Data in
Electronic Format to the Center for
Veterinary Medicine’’—21 CFR 58.120
and 514.117(b) (OMB Control Number
0910–0524—Extension)
Protocols for nonclinical laboratory
studies (safety studies), are required
under 21 CFR 58.120 for approval of
new animal drugs. Protocols for
adequate and well-controlled
effectiveness studies are required under
21 CFR 514.117(b). Upon request by the
animal drug sponsors, the Center for
Veterinary Medicine (CVM) reviews
protocols for safety and effectiveness
studies. CVM and the sponsor consider
this to be an essential part of the basis
for making the decision to approve or
not approve an animal drug application
or supplemental animal drug
application. The establishment of a
process for acceptance of the electronic
submission of protocols for studies
conducted by sponsors in support of
new animal drug applications is part of
CVM’s ongoing initiative to provide a
method for paperless submissions.
Sponsors may submit protocols to CVM
in paper format. CVM’s guidance on
how to submit a study protocol permits
sponsors to submit a protocol without
data as an e-mail attachment via the
Internet. Further, this guidance also
electronically implements provisions of
the Government Paperwork Elimination
Act (GPEA). The GPEA required Federal
agencies, by October 21, 2003, to
provide the following: (1) The option of
electronic maintenance, submission, or
disclosure of information, if practicable,
as a substitution for paper and (2) the
use and acceptance of electronic
signatures, where applicable. FDA Form
3536 is used to facilitate the use of
electronic submission of protocols. This
collection of information is for the
benefit of animal drug sponsors, giving
them the flexibility to submit data for
review via the Internet.
The likely respondents are sponsors
of new animal drug applications.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section/FDA Form 3536
No. of
Respondents
514.117(b) and 58.120
1 There
Annual Frequency
per Response
40
Total Annual
Responses2
1.8
Hours per
Response
72
Total Hours
.20
14.4
are no capital costs or operating and maintenance costs associated with this collection of information.
submissions received between January 1, 2008, and December 31, 2008.
2 Electronic
The number of respondents in table 1
of this document is the number of
sponsors registered to make electronic
submissions (40). The number of total
annual responses is based on a review
of the actual number of such
submissions made between July 1, 2005,
and June 30, 2006, (72 x .20 hours per
response = 14.4 total hours).
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3026 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
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,
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
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
VerDate Nov<24>2008
14:39 Feb 17, 2010
Jkt 220001
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
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.
DATES: Submit written or electronic
comments on the collection of
information by April 19, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\18FEN1.SGM
18FEN1
7279
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
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 (hereinafter referred to as the
June 7, 2006, 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 will apply 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 June 7, 2006,
interim final 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) 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 the
June 7, 2006, interim final rule, 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 the burden of the
collection of information as follows:
TABLE 1.—ESTIMATED AVERAGE ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
of Responses
Total Annual
Responses
Hours per
response
Total hours
50.23(e)(1)(2)
150
3
450
2
900
50.23(e)(4)
150
3
450
1
450
Total
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
1350
are no capital costs or operating and maintenance costs associated with this collection of information
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 Centers
for Disease Controls’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
VerDate Nov<24>2008
14:39 Feb 17, 2010
Jkt 220001
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.
This interim final rule refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 50.25 have
been approved under 0910–0130.
PO 00000
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3025 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0496]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tobacco Product
Standard on Flavored Cigarettes
AGENCY:
Food and Drug Administration,
HHS.
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7278-7279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3025]
-----------------------------------------------------------------------
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 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 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.
DATES: Submit written or electronic comments on the collection of
information by April 19, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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.
[[Page 7279]]
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 (hereinafter referred to as the June 7, 2006,
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 will apply
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 June 7, 2006, interim final 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) 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 the June 7, 2006, interim final rule,
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 the burden of the collection of information as
follows:
Table 1.--Estimated Average Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section Respondents Responses Responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
50.23(e)(1)(2) 150 3 450 2 900
--------------------------------------------------------------------------------------------------------------------------------------------------------
50.23(e)(4) 150 3 450 1 450
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1350
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information
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 Centers for
Disease Controls'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.
This interim final rule refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 50.25 have been
approved under 0910-0130.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3025 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S
