Proposed Information Collection Activity: Comment Request, 35549-35550 [2014-14566]
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35549
Federal Register / Vol. 79, No. 120 / Monday, June 23, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity: Comment Request
Title: Innovative Strategies for
Increasing Self-Sufficiency: Follow-Up
Data Collections.
OMB No.: 0970–0397.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing a data
collection activity as part of the
Innovative Strategies for Increasing SelfSufficiency (ISIS) evaluation. ISIS is an
evaluation of 9 promising career
pathways strategies to promote
education, employment, and selfsufficiency. The major goal of ISIS is to
increase the empirical knowledge about
the effectiveness of programs for lowincome individuals and families to
achieve educational credentials, attain
employment and advance to positions
that enable self-sufficiency.
ISIS is one project within the broader
portfolio of research that OPRE is
utilizing to assess the success of the
career pathways programs and models.
In addition to ISIS, this strategy
includes a multi-pronged research and
evaluation approach for the Health
Profession Opportunity Grants (HPOG)
Program to better understand and assess
the activities conducted and their
results. In order to maximize learning
across this portfolio, survey
development for the HPOG and ISIS
baseline and follow up surveys is being
coordinated, and the majority of the
data elements collected in these surveys
are similar.
Two data collection efforts have been
approved for ISIS, including one for
baseline data collection (approved
November 2011), a second for data
collection activities to document
program implementation, data
collection activities for an initial followup survey of participants to be
administered approximately 15 months
after random assignment, and data
collection through in-depth interviews
for a small sample of study participants
(approved August 2013). Additionally,
three related data collection efforts for
HPOG research were approved by OMB
under OMB #0970–0394. These include
approval of a Performance Reporting
System (PRS) (approved September
2011), for collection of additional
baseline data for the HPOG-Impact
study (approved October 2012), and for
collection of data for the National
Implementation Evaluation (approved
August 2013). Additionally, a new
request is being submitted at the same
time as this request.
This Federal Register Notice provides
the opportunity to comment on a
proposed new information collection
activity for ISIS—a second follow-up
survey for ISIS participants
approximately 36 months after program
enrollment. The purpose of the survey
is to follow-up with study participants
to document their education and
training experiences, employment
experiences, and parenting practices
and child outcomes for participants
with children.
Data collection activities to submit in
a future information collection request
include a third follow-up survey for ISIS
study participants approximately 60
months after study enrollment.
Previously approved collection
activities under 0970–0397 will
continue under this new request,
including additional data collection
using the following previously approved
instruments: The Basic Information
Form; the Self-Administered
Questionnaire; 15-Month Follow-Up
Survey; 15-Month Follow-Up Survey
Tracking Letters; Study Participant Indepth Interview Guide; and Study
Participant Check-in Call the estimated
number of study participants for the 15Month Survey and in-depth interviews
is reduced from the previous OMB
submission. Total sample size targets
were reduced at a number of ISIS
program sites to reflect actual study
enrollment experiences. The number of
in-depth interviews projected was also
reduced to incorporate experiences to
date recruiting participants.
Respondents: Individuals enrolled in
the ISIS study.
ANNUAL BURDEN ESTIMATES
[This information collection request is for a three-year period]
Total
number of
respondents
Instrument
Annual
number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Annual
burden
hours
1
1
1
3
1
1
.25
.33
0.833
0.083
1
.16
2
3
805
148
48
8
1
6
1
0.083
2,462
1,226
Previously Approved Instruments
Baseline data collection: Basic Information Form .............
Baseline data collection: Self-administered Questionnaire
15 Month Follow-up Survey ...............................................
15-Month Follow-up Survey Tracking Letters ....................
Study Participant In-depth Interview Guide .......................
Study Participant Check-in Call .........................................
24
24
2,900
1,782
144
144
8
8
967
594
48
48
Current Request for Approval
emcdonald on DSK67QTVN1PROD with NOTICES
36-Month Follow-up Survey ...............................................
36-Month Follow-up Survey Tracking Letters ....................
Estimated Total Annual Burden
Hours: 4,702.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
VerDate Mar<15>2010
17:33 Jun 20, 2014
Jkt 232001
7,386
7,386
2,462
2,462
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Email address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
E:\FR\FM\23JNN1.SGM
23JNN1
35550
Federal Register / Vol. 79, No. 120 / Monday, June 23, 2014 / Notices
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2014–14566 Filed 6–20–14; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0670]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Novel Influenza A (H7N9)
Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for
detection of the novel influenza A
(H7N9) virus (detected in China in
2013). FDA is issuing this Authorization
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
requested by Arbor Vita Corporation.
The Authorization contains, among
other things, conditions on the
emergency use of the authorized in vitro
diagnostic device. The Authorization
follows the April 19, 2013,
determination by the Secretary of Health
and Human Services (HHS) that there is
a significant potential for a public
health emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad and that involves the
novel influenza A (H7N9) virus. On the
basis of such determination, the
Secretary of HHS also declared on April
19, 2013, that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostics for
detection of the novel influenza A
(H7N9) virus subject to the terms of any
authorization issued under the FD&C
Act. The Authorization, which includes
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:33 Jun 20, 2014
Jkt 232001
an explanation of the reasons for
issuance, is reprinted in this document.
DATES: The Authorization is effective as
of April 25, 2014.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Luciana Borio, Assistant Commissioner
for Counterterrorism Policy, Office of
Counterterrorism and Emerging Threats,
and Acting Deputy Chief Scientist, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 4340,
Silver Spring, MD 20993–0002, 301–
796–8510 (this is not a toll free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
a military emergency, involving a
heightened risk to U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; 1 or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service Act (PHS Act) (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
1 As amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 (Public
Law 113–5), the Secretary of HHS may make a
determination of a public health emergency, or a
significant potential for a public health emergency,
under section 564 of the FD&C Act. The Secretary
of HHS is no longer required to make a
determination of a public health emergency under
section 319 of the PHS Act (42 U.S.C. 247d) to
support a determination made under section 564 of
the FD&C Act.
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 79, Number 120 (Monday, June 23, 2014)]
[Notices]
[Pages 35549-35550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14566]
[[Page 35549]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity: Comment Request
Title: Innovative Strategies for Increasing Self-Sufficiency:
Follow-Up Data Collections.
OMB No.: 0970-0397.
Description: The Administration for Children and Families (ACF),
U.S. Department of Health and Human Services (HHS), is proposing a data
collection activity as part of the Innovative Strategies for Increasing
Self-Sufficiency (ISIS) evaluation. ISIS is an evaluation of 9
promising career pathways strategies to promote education, employment,
and self-sufficiency. The major goal of ISIS is to increase the
empirical knowledge about the effectiveness of programs for low-income
individuals and families to achieve educational credentials, attain
employment and advance to positions that enable self-sufficiency.
ISIS is one project within the broader portfolio of research that
OPRE is utilizing to assess the success of the career pathways programs
and models. In addition to ISIS, this strategy includes a multi-pronged
research and evaluation approach for the Health Profession Opportunity
Grants (HPOG) Program to better understand and assess the activities
conducted and their results. In order to maximize learning across this
portfolio, survey development for the HPOG and ISIS baseline and follow
up surveys is being coordinated, and the majority of the data elements
collected in these surveys are similar.
Two data collection efforts have been approved for ISIS, including
one for baseline data collection (approved November 2011), a second for
data collection activities to document program implementation, data
collection activities for an initial follow-up survey of participants
to be administered approximately 15 months after random assignment, and
data collection through in-depth interviews for a small sample of study
participants (approved August 2013). Additionally, three related data
collection efforts for HPOG research were approved by OMB under OMB
0970-0394. These include approval of a Performance Reporting
System (PRS) (approved September 2011), for collection of additional
baseline data for the HPOG-Impact study (approved October 2012), and
for collection of data for the National Implementation Evaluation
(approved August 2013). Additionally, a new request is being submitted
at the same time as this request.
This Federal Register Notice provides the opportunity to comment on
a proposed new information collection activity for ISIS--a second
follow-up survey for ISIS participants approximately 36 months after
program enrollment. The purpose of the survey is to follow-up with
study participants to document their education and training
experiences, employment experiences, and parenting practices and child
outcomes for participants with children.
Data collection activities to submit in a future information
collection request include a third follow-up survey for ISIS study
participants approximately 60 months after study enrollment.
Previously approved collection activities under 0970-0397 will
continue under this new request, including additional data collection
using the following previously approved instruments: The Basic
Information Form; the Self-Administered Questionnaire; 15-Month Follow-
Up Survey; 15-Month Follow-Up Survey Tracking Letters; Study
Participant In-depth Interview Guide; and Study Participant Check-in
Call the estimated number of study participants for the 15-Month Survey
and in-depth interviews is reduced from the previous OMB submission.
Total sample size targets were reduced at a number of ISIS program
sites to reflect actual study enrollment experiences. The number of in-
depth interviews projected was also reduced to incorporate experiences
to date recruiting participants.
Respondents: Individuals enrolled in the ISIS study.
Annual Burden Estimates
[This information collection request is for a three-year period]
----------------------------------------------------------------------------------------------------------------
Total number Annual number Number of Average burden
Instrument of of responses per hours per Annual burden
respondents respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Previously Approved Instruments
----------------------------------------------------------------------------------------------------------------
Baseline data collection: Basic 24 8 1 .25 2
Information Form...............
Baseline data collection: Self- 24 8 1 .33 3
administered Questionnaire.....
15 Month Follow-up Survey....... 2,900 967 1 0.833 805
15-Month Follow-up Survey 1,782 594 3 0.083 148
Tracking Letters...............
Study Participant In-depth 144 48 1 1 48
Interview Guide................
Study Participant Check-in Call. 144 48 1 .16 8
----------------------------------------------------------------------------------------------------------------
Current Request for Approval
----------------------------------------------------------------------------------------------------------------
36-Month Follow-up Survey....... 7,386 2,462 1 1 2,462
36-Month Follow-up Survey 7,386 2,462 6 0.083 1,226
Tracking Letters...............
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 4,702.
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email
address: OPREinfocollection@acf.hhs.gov. All requests should be
identified by the title of the information collection.
The Department specifically requests comments on (a) whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including
[[Page 35550]]
whether the information shall have practical utility; (b) the accuracy
of the agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2014-14566 Filed 6-20-14; 8:45 am]
BILLING CODE 4184-09-P
