Agency Information Collection Activities; Proposed Collection; Comment Request; Exception From General Requirements for Informed Consent, 19915-19917 [2014-08006]
Download as PDF
<![CDATA[
19915
Federal Register / Vol. 79, No. 69 / Thursday, April 10, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondents
Form name
Patients .............................................
Controls .............................................
Case questionnaire ..........................
Control questionnaire .......................
Average
burden
per response
(in hours)
Total
[FR Doc. 2014–08014 Filed 4–9–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ACF Program Instruction:
Children’s Justice Act.
OMB No.: 0970–0425.
1
1
25/60
25/60
67
201
........................
LeRoy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
161
483
........................
........................
268
Description: The Program Instruction,
prepared in response to the enactment
of the Childrens Justice Act (CJA), Title
II of Public Law 111–320, Child Abuse
Prevention and Treatment Act
Reauthorization of 2010, provides
direction to the States and Territories to
accomplish the purposes of assisting
States in developing, establishing and
operating programs designed to
improve: (1) The assessment and
investigation of suspected child abuse
and neglect cases, including cases of
suspected child sexual abuse and
exploitation, in a manner that limits
additional trauma to the child and the
child’s family; (2) the assessment and
investigation of cases of suspected child
abuse-related fatalities and suspected
child neglect-related fatalities; (3) the
investigation and prosecution of cases of
child abuse and neglect, including child
sexual abuse and exploitation; and (4)
the assessment and investigation of
cases involving children with
disabilities or serious health-related
problems who are suspected victims of
child abuse or neglect. This Program
Instruction contains information
collection requirements that are found
in Public Law 111–320 at Sections
107(b) and 107(d), and pursuant to
receiving a grant award. The
information being collected is required
by statute to be submitted pursuant to
receiving a grant award. The
information submitted will be used by
the agency to ensure compliance with
the statute; to monitor, evaluate and
measure grantee achievements in
addressing the investigation and
prosecution of child abuse and neglect;
and to report to Congress.
Respondents: State Governments.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Application and Annual Report ........................................................................
52
1
60
3,120
Estimated Total Annual Burden
Hours: 3,120.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–08065 Filed 4–9–14; 8:45 am]
BILLING CODE 4184–01–P
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.
Notice.
sroberts on DSK5SPTVN1PROD with NOTICES
OMB Comment
ACTION:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
SUMMARY:
VerDate Mar<15>2010
18:14 Apr 09, 2014
Jkt 232001
PO 00000
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
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\10APN1.SGM
10APN1
sroberts on DSK5SPTVN1PROD with NOTICES
19916
Federal Register / Vol. 79, No. 69 / Thursday, April 10, 2014 / Notices
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information related to
the use of investigational in vitro
diagnostic devices to identify chemical,
biological, radiological, or nuclear
agents without informed consent in
certain circumstances.
DATES: Submit either electronic or
written comments on the collection of
information by June 9, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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
VerDate Mar<15>2010
18:14 Apr 09, 2014
Jkt 232001
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 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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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
E:\FR\FM\10APN1.SGM
10APN1
19917
Federal Register / Vol. 79, No. 69 / Thursday, April 10, 2014 / Notices
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/21 CFR Section
Written certification (sent to
FDA)—50.23(e)(3).
1 There
Number of
responses per
respondent
Number of
respondents
150
Total
annual
responses
3
Average
burden per
response
450
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 REPORTING BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR Section
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Total
operating and
maintenance
costs
Written certification (sent to IRB)—
50.23(e)(1) and (e)(2) ...........................
Informed
consent
information—
50.23(e)(4) ............................................
150
3
450
2
900
$0
150
3
450
1
450
100
Total ..................................................
........................
........................
........................
........................
1,350
100
1 There
are no capital costs associated with this collection of information.
Dated: April 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
The
Division of Program Coordination,
Planning, and Strategic Initiatives,
Office of the Director, NIH at dpcpsi@
od.nih.gov.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2014–08006 Filed 4–9–14; 8:45 am]
BILLING CODE 4160–01–P
SUPPLEMENTARY INFORMATION:
Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Announcement of Agency Decision:
Density of the Primary Living Space of
Captive Chimpanzees Owned or
Supported by the National Institutes of
Health (NIH) or Used in NIH-Supported
Research
This notice summarizes the
agency’s actions to obtain additional
scientific input and announces the
agency’s decision with respect to the
space density of the primary living
space of captive research chimpanzees
owned or supported by the National
Institutes of Health (NIH) or used in
NIH-supported research. The NIH has
prepared procedural guidance and
technical assistance for researchers,
facility staff, and agency staff to ensure
proper implementation of the agency’s
decisions. Investigators should follow
guidance (see NOT–OD–14–024 at
https://www.grants.nih.gov/grants/guide/
notice-files/NOT-OD-14-024.html)
regarding the submission of
applications, proposals, or protocols for
research involving chimpanzees.
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:14 Apr 09, 2014
Jkt 232001
In February 2012, the NIH charged a
working group of the Council of
Councils, a federal advisory committee,
to provide advice on implementing
recommendations made by the Institute
of Medicine (IOM) Committee on the
Use of Chimpanzees in Biomedical and
Behavioral Research in its 2011 report,
Chimpanzees in Biomedical and
Behavioral Research: Assessing the
Necessity. On January 22, 2013, the NIH
Council of Councils (Council) accepted
recommendations presented by the
Working Group on the Use of
Chimpanzees in NIH-Supported
Research in its report (see https://
dpcpsi.nih.gov/sites/default/files/FNL_
Report_WG_Chimpanzees_0.pdf) and
provided these recommendations to the
NIH. The NIH subsequently issued a
request for information, https://
www.gpo.gov/fdsys/pkg/FR-2013-02-05/
html/2013-02507.htm, to obtain broad
public input on the 28 Council
recommendations the NIH considered as
it determined how to implement the
IOM Committee’s recommendations.
In June 2013, the NIH announced its
decisions with respect to the Council of
Councils’ recommendations; see https://
dpcpsi.nih.gov/sites/default/files/NIH_
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
response_to_Council_of_Councils_
recommendations_62513.pdf. The
agency accepted 27 of the 28 Council
recommendations. Included in these
were 10 recommendations describing
the characteristics of a captive
environment that allow for and promote
a full range of behaviors that are natural
for chimpanzees—or ethologically
appropriate environments (EAE). The
NIH accepted 9 of the 10 Council’s
recommendations on EAE, including
recommendations on enclosure height,
foraging and diet, nesting materials,
enrichment, a staff to chimpanzee ratio,
staff training, and recordkeeping. The
NIH did not accept Recommendation
EA2—‘‘The density of the primary
living space of chimpanzees should be
at least 1,000 ft2 (93 m2) per individual.
Therefore, the minimum outdoor
enclosure size for a group of 7 animals
should be 7,000 ft2 (651 m2).’’—based
on comments received from the public.
Because of concerns about the scientific
basis for this recommendation and the
expected costs of implementing it, the
agency further reviewed the space
density requirements with respect to the
promotion of species-appropriate
behavior.
While a large number of commenters
who addressed Recommendation EA2
supported the recommendation, some
commenters emphasized the amount of
space recommended is the minimum
needed and larger enclosures that more
closely replicate the amount of space
available to chimpanzees in the wild are
E:\FR\FM\10APN1.SGM
10APN1
]]>Agencies
[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Pages 19915-19917]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08006]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0062]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exception From General Requirements for Informed
Consent
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of
[[Page 19916]]
information, including each proposed extension of an existing
collection of information, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on the collection
of information related to the use of investigational in vitro
diagnostic devices to identify chemical, biological, radiological, or
nuclear agents without informed consent in certain circumstances.
DATES: Submit either electronic or written comments on the collection
of information by June 9, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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.
Medical Devices; Exception From General Requirements for Informed
Consent--21 CFR 50.23 (OMB Control Number 0910-0586)--Extension
In the Federal Register of June 7, 2006 (71 FR 32827), FDA issued
an interim final rule to amend its regulations to establish a new
exception from the general requirements for informed consent, to permit
the use of investigational in vitro diagnostic devices to identify
chemical, biological, radiological, or nuclear agents without informed
consent in certain circumstances. The Agency took this action because
it was concerned that, during a potential terrorism event or other
potential public health emergency, delaying the testing of specimens to
obtain informed consent may threaten the life of the subject. In many
instances, there may also be others who have been exposed to, or who
may be at risk of exposure to, a dangerous chemical, biological,
radiological, or nuclear agent, thus necessitating identification of
the agent as soon as possible. FDA created this exception to help
ensure that individuals who may have been exposed to a chemical,
biological, radiological, or nuclear agent are able to benefit from the
timely use of the most appropriate diagnostic devices, including those
that are investigational.
Section 50.23(e)(1) (21 CFR 50.23(e)(1)) provides an exception to
the general rule that informed consent is required for the use of an
investigational in vitro diagnostic device. This exception applies to
those situations in which the in vitro investigational diagnostic
device is used to prepare for, and respond to, a chemical, biological,
radiological, or nuclear terrorism event or other public health
emergency, if the investigator and an independent licensed physician
make the determination and later certify in writing that: (1) There is
a life-threatening situation necessitating the use of the
investigational device, (2) obtaining informed consent from the subject
is not feasible because there was no way to predict the need to use the
investigational device when the specimen was collected and there is not
sufficient time to obtain consent from the subject or the subject's
legally authorized representative, and (3) no satisfactory alternative
device is available. Under the rule, these determinations are made
before the device is used, and the written certifications are made
within 5 working days after the use of the device. If use of the device
is necessary to preserve the life of the subject and there is not
sufficient time to obtain the determination of the independent licensed
physician in advance of using the investigational device, Sec.
50.23(e)(2) provides that the certifications must be made within 5
working days of use of the device. In either case, the certifications
are submitted to the Institutional Review Board (IRB) and, under Sec.
50.23(e)(3) (76 FR 36989, June 24, 2011), to FDA within 5 working days
of the use of the device.
Section 50.23(e)(4) provides that an investigator must disclose the
investigational status of the device and what is known about the
performance characteristics of the device at the time test results are
reported to the subject's health care provider and public health
authorities, as applicable. Under Sec. 50.23(e)(4), the investigator
provides the IRB with the information required by Sec. 50.25 (21 CFR
50.25) (except for the information described in Sec. 50.25(a)(8)) and
the procedures that will be used to provide this information to each
subject or the subject's legally authorized representative.
From its knowledge of the industry, FDA estimates that there are
approximately 150 laboratories that could perform testing that uses
investigational in vitro diagnostic devices to identify chemical,
biological, radiological, or nuclear agents. FDA estimates that in the
United States each year there are approximately 450 naturally occurring
cases of diseases or conditions that are identified in the Centers for
Disease Control's list of category ``A'' biological threat agents. The
number of cases that would result from a terrorist event or other
public health emergency is uncertain. Based on its knowledge of similar
types of submissions, FDA estimates that it will take about 2 hours to
prepare each certification.
Based on its knowledge of similar types of submissions, FDA
estimates that it will take about 1 hour to prepare a report disclosing
the investigational status of the in vitro diagnostic device and what
is known about the performance characteristics of the device and submit
it to the health care provider and, where appropriate, to public health
authorities.
The June 7, 2006, interim final rule refers to previously approved
collections of information found in FDA regulations. These collections
of
[[Page 19917]]
information are subject to review by OMB under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
Sec. 50.25 have been approved under 0910-0130.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual operating and
Activity/21 CFR Section respondents responses per responses Average burden per response Total hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to FDA)-- 150 3 450 0.25 (15 minutes)........... 113 $100
50.23(e)(3).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden operating and
Activity/21 CFR Section respondents disclosures disclosures per disclosure Total hours maintenance
per respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written certification (sent to IRB)--50.23(e)(1) and 150 3 450 2 900 $0
(e)(2).................................................
Informed consent information--50.23(e)(4)............... 150 3 450 1 450 100
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 1,350 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Dated: April 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08006 Filed 4-9-14; 8:45 am]
BILLING CODE 4160-01-P
