Agency Information Collection Activities: Proposed Collection; Comment Request, 19331-19332 [2015-08272]
Download as PDF
Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
completely rescued by basolateral
addition of IFN-gamma. These results
suggest that IFN-gamma can be used to
reduce adverse events (retinal edema)
associated with the therapeutic use of
MEKis.
Potential Commercial Applications:
Treatment for or prevention of adverse
side effects in cancer patients
undergoing MEK inhibitor therapy.
Competitive Advantages: A simple
and unique mode of reducing or
eliminating ocular side effects in cancer
patients undergoing treatments with
MEK inhibitors.
Development Stage:
• Early-stage.
• In vitro data available.
Inventors: Sheldon S. Miller (NEI),
Arvydas Maminishkis (NEI), Charlotte
´
E. Reme (Merck KGaA).
Intellectual Property: HHS Reference
No. E–248–2012/0—
• US Provisional Application No. 61/
721,810 filed 02 Nov 2012.
• PCT Patent Application No. PCT/
US2013/068056 filed 01 Nov 2013.
Related Technologies: HHS Reference
No. E–169–2008/0—
• US Patent No. 8,697,046 issued 15
Apr 2014 (Methods of Administering
Interferon Gamma to Absorb Fluid From
the Subretinal Space; Li R, et al.).
• US Patent Application No. 14/
252,489 filed 14 Apr 2014.
Licensing Contact: Suryanarayana
Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
Lubiprostone To Treat Retinal Diseases
Associated With Fluid Accumulation in
Retina & Subretinal Space
Description of Technology: Use of
Lubiprostone for treating age-related
macular degeneration, chronic macular
edema, diabetic retinopathy, retinal
detachment, glaucoma, or uveitis by
decreasing excess fluid accumulation in
the retina and/or subretinal space (SRS)
is described. The retinal pigment
epithelium (RPE) is a highly pigmented,
terminally differentiated monolayer of
cells at the back of the eye. The RPE
performs numerous processes that are
critical for the maintenance of
photoreceptor cell health and function.
The pathological accumulation of fluid
beneath the RPE is a symptom and a
contributing factor in the loss of vision
in a variety of ocular conditions.
Previously, the inventors have shown
that human RPE contains apical and
basolateral membrane receptors that can
be activated to increase cell cAMP or Ca
followed by basolateral membrane
activation of CFTR or Ca-activated
chloride channels resulting in a
clinically significant increase in fluid
absorption across the RPE. For the first
VerDate Sep<11>2014
20:09 Apr 09, 2015
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time, using human RPE in vitro, the
inventors demonstrated that
lubiprostone can increase fluid
transport from the retinal to the
choroidal side of the RPE by activating
CLC–2 at the RPE basolateral membrane.
Further, they also showed that this
increase can be blocked by addition of
methadone, a specific CLC–2 channel
blocker. Lubiprostone added from either
the apical or basolateral side of the
epithelium. Methadone also increased
transepithelial potential (TEP) and this
increase is consistent with a
lubiprostone-induced increase in
basolateral membrane CLC–2
conductance and subsequent membrane
depolarization. These results suggest
lubiprostone can be a therapeutic in
retinal disease to increase fluid
absorption from retina and subretinal
space.
Potential Commercial Applications:
Treatment for or prevention of agerelated macular degeneration, chronic
macular edema, diabetic retinopathy,
retinal detachment, glaucoma, or uveitis
by decreasing the amount of fluid
present in the subretinal space (SRS).
Competitive Advantages: A simple
and novel therapeutic for retinal
diseases characterized by the abnormal
fluid accumulation in subretinal space.
Development Stage:
• Early-stage.
• In vitro data available.
Inventors: Sheldon S. Miller, Arvydas
Maminishkis, Jeffrey Adijanto, Tina M.
Banzon, and Qin Wan (all of NEI).
Intellectual Property: HHS Reference
No. E–283–2012/0—
• U.S. Provisional Application No.
61/777,073 filed 12 Mar 2013.
• PCT Patent Application No. PCT/
US2014/024724 filed 12 Mar 2014.
Related Technology: HHS Reference
No. E–169–2008/0—
• U.S. Patent No. 8,697,046 issued 15
Apr 2014 (Methods of Administering
Interferon Gamma to Absorb Fluid From
the Subretinal Space; Li R, et al.).
• U.S. Patent Application No. 14/
252,489 filed 14 Apr 2014.
Licensing Contact: Suryanarayana
Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
Dated: March 7, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–08290 Filed 4–9–15; 8:45 am]
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19331
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including 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) ways to enhance 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.
Proposed Project: Family Treatment
Drug Court Services Evaluation (OMB
No. 0930–0330)—REINSTATEMENT
In 2010, the Substance Abuse and
Mental Health Services Administration
(SAMHSA), Center for Substance Abuse
Treatment (CSAT), provided funding to
12 existing Family Treatment Drug
Courts (FTDCs) for enhancement and/or
expansion of their FTDC’s capabilities
to provide psycho-social, emotional and
mental health services to children (0–17
years) and their families who have
methamphetamine use disorders and
involvement in child protective
services. This program was authorized
in House Report 111–220 accompanying
HR 3293 in 2010. The Committee
language stated that ‘‘these grants will
support a collaborative approach,
including treatment providers, child
welfare specialists, and judges, to
provide community-based social
services for the children of
methamphetamine-addicted parents,’’
and were to be awarded to Family
Dependency Treatment Drug Courts.
E:\FR\FM\10APN1.SGM
10APN1
19332
Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Notices
SAMHSA is requesting to reinstate
OMB approval of instruments used in
the Children Affected by
Methamphetamine (CAM) grant
program through 2020 for a new cohort
of grantees under the new program
name of Family Treatment Drug Courts,
or FTDCs. The continued use of these
instruments will allow SAMHSA to
collect data on The FTDC grantees that
is not otherwise captured: The national
evaluation of the FTDC project will
collect data on: (1) Child Outcomes; (2)
Parent/Caregiver Outcomes; and (3)
Family Functioning. The results from
this data collection will serve to inform
future decisions regarding funding by
SAMHSA as well as establish an
evidence base for the practices
undertaken for other localities and
programs implementing Family
Treatment Drug Courts. The overall
reporting burden is estimated at 720.5
hours.
Providing children’s services in an
FTDC was a new activity for FTDCs and
the grantees. The purpose of the
evaluation was to monitor the grantees
progress and to measure their
performance on child, family and adult
outcomes. These outcomes were
compared to referent data available at
the local and/or State level, and to prepost measures for family functioning.
Previous data collection efforts have
measured occurrence of maltreatment
and substance exposed newborns, The
child/youth indicators related to
permanency assess whether they remain
in their home, the length of stay in
foster care (if they are out of their
home), the proportion who re-enter
foster care, the proportion who were
reunified, the length of time to
reunification and whether the children
and youth exit services with adoption or
legal guardianship if they are not
reunified with their parents. The adult
indicators related to recovery include
substance use, access to treatment,
treatment outcomes, employment and
criminal behavior. The results of the
evaluations were used by grantees to
measure the progress of their programs,
and aided their efforts to sustain the
activities once the grants ended.
To the greatest extent possible, the
data elements are operationally defined
using standard definitions in child
welfare and substance abuse treatment.
The use of standard data definitions
will reduce the data collection burden
on grantees as these variables are
collected through data collection
procedures that currently exist through
all publically funded child welfare and
substance abuse treatment systems. The
FTDC performance measures are data
currently collected by programs as part
of their normal operations (e.g.,
placement status in child welfare
services, substance abuse treatment
entry dates). Thus, minimal data
collection from clients will be required
as the grantees will be abstracting
existing data. The only new information
collected will be from the North
Carolina Family Assessment Scale
(NCFAS) assessment obtained from
participants during the intake and
discharge interviews. If needed, the
FTDC staff member may supplement
this information by obtaining
information from other staff that interact
with the client (i.e., the social worker
familiar with the family) or during a
home visit (if this is part of their
program activities).
It should be re-emphasized that the
FTDC projects are expansions or
enhancements of FTDC partnerships
that currently have existing
relationships (and information sharing/
confidentiality agreements) in place. It
is through this existing information
sharing forum that the FTDC grantees
will be able to obtain the requisite child
welfare and substance abuse treatment
performance measures. The grantees
will use electronic abstraction and
secondary data collection for elements
that are already being collected by
counties and States in their reporting
requirements of Federally-mandated
data.
Table 1 presents the estimated total
cost burden associated with the
collection of the FTDC data elements.
The following estimates represent the
number of anticipated participants
based on experience with the previous
CAM program. There are two sources of
data collection burden for the
performance system. First, FTDC staff
extracts data from secondary sources for
the child, parent/caregiver and family
functioning data elements for biannual
data uploads. The total number of
responses is two per year; with each
upload taking approximately 16 hours at
each site. In addition to the data
extraction, FTDC staff will complete 2
administrations (intake and discharge)
of the NCFAS for each family
(approximately 267 families per year
based on estimates extrapolated from
the CAM program). The NCFAS takes
approximately .75 hours to complete per
family per administration. The
estimated total cost of the time FTDC
staff will spend completing data
collection is $15,952 per year (total
number of staff hours, 720.5 hours,
multiplied by $22.14, the estimated
average hourly wages for social work
professionals as published by the
Bureau of Labor Statistics, 2013). See
Table 1.
TABLE 1—ANNUALIZED HOUR BURDEN
Number of
records
Form/instrument
Responses
per record
Total
responses
Hours per
response
Total hour
burden
FTDC Form—Biannual extraction of extant data x 10
grantees ............................................................................
NCFAS—Administered twice for each family ......................
10
267
2
2
20
534
16
.75
320
400.5
Total ..............................................................................
277
........................
554
........................
720.5
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Note: The estimated response burden includes the extractions and uploads to the FTDC Form and administration the North Carolina Family
Assessment Form.
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 2–1057, One Choke Cherry Road,
Rockville, MD 20857 or email her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
by June 9, 2015.
Summer King,
Statistician.
[FR Doc. 2015–08272 Filed 4–9–15; 8:45 am]
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Agencies
[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Notices]
[Pages 19331-19332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08272]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including 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) ways to enhance 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.
Proposed Project: Family Treatment Drug Court Services Evaluation (OMB
No. 0930-0330)--REINSTATEMENT
In 2010, the Substance Abuse and Mental Health Services
Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT),
provided funding to 12 existing Family Treatment Drug Courts (FTDCs)
for enhancement and/or expansion of their FTDC's capabilities to
provide psycho-social, emotional and mental health services to children
(0-17 years) and their families who have methamphetamine use disorders
and involvement in child protective services. This program was
authorized in House Report 111-220 accompanying HR 3293 in 2010. The
Committee language stated that ``these grants will support a
collaborative approach, including treatment providers, child welfare
specialists, and judges, to provide community-based social services for
the children of methamphetamine-addicted parents,'' and were to be
awarded to Family Dependency Treatment Drug Courts.
[[Page 19332]]
SAMHSA is requesting to reinstate OMB approval of instruments used
in the Children Affected by Methamphetamine (CAM) grant program through
2020 for a new cohort of grantees under the new program name of Family
Treatment Drug Courts, or FTDCs. The continued use of these instruments
will allow SAMHSA to collect data on The FTDC grantees that is not
otherwise captured: The national evaluation of the FTDC project will
collect data on: (1) Child Outcomes; (2) Parent/Caregiver Outcomes; and
(3) Family Functioning. The results from this data collection will
serve to inform future decisions regarding funding by SAMHSA as well as
establish an evidence base for the practices undertaken for other
localities and programs implementing Family Treatment Drug Courts. The
overall reporting burden is estimated at 720.5 hours.
Providing children's services in an FTDC was a new activity for
FTDCs and the grantees. The purpose of the evaluation was to monitor
the grantees progress and to measure their performance on child, family
and adult outcomes. These outcomes were compared to referent data
available at the local and/or State level, and to pre-post measures for
family functioning. Previous data collection efforts have measured
occurrence of maltreatment and substance exposed newborns, The child/
youth indicators related to permanency assess whether they remain in
their home, the length of stay in foster care (if they are out of their
home), the proportion who re-enter foster care, the proportion who were
reunified, the length of time to reunification and whether the children
and youth exit services with adoption or legal guardianship if they are
not reunified with their parents. The adult indicators related to
recovery include substance use, access to treatment, treatment
outcomes, employment and criminal behavior. The results of the
evaluations were used by grantees to measure the progress of their
programs, and aided their efforts to sustain the activities once the
grants ended.
To the greatest extent possible, the data elements are
operationally defined using standard definitions in child welfare and
substance abuse treatment. The use of standard data definitions will
reduce the data collection burden on grantees as these variables are
collected through data collection procedures that currently exist
through all publically funded child welfare and substance abuse
treatment systems. The FTDC performance measures are data currently
collected by programs as part of their normal operations (e.g.,
placement status in child welfare services, substance abuse treatment
entry dates). Thus, minimal data collection from clients will be
required as the grantees will be abstracting existing data. The only
new information collected will be from the North Carolina Family
Assessment Scale (NCFAS) assessment obtained from participants during
the intake and discharge interviews. If needed, the FTDC staff member
may supplement this information by obtaining information from other
staff that interact with the client (i.e., the social worker familiar
with the family) or during a home visit (if this is part of their
program activities).
It should be re-emphasized that the FTDC projects are expansions or
enhancements of FTDC partnerships that currently have existing
relationships (and information sharing/confidentiality agreements) in
place. It is through this existing information sharing forum that the
FTDC grantees will be able to obtain the requisite child welfare and
substance abuse treatment performance measures. The grantees will use
electronic abstraction and secondary data collection for elements that
are already being collected by counties and States in their reporting
requirements of Federally-mandated data.
Table 1 presents the estimated total cost burden associated with
the collection of the FTDC data elements. The following estimates
represent the number of anticipated participants based on experience
with the previous CAM program. There are two sources of data collection
burden for the performance system. First, FTDC staff extracts data from
secondary sources for the child, parent/caregiver and family
functioning data elements for biannual data uploads. The total number
of responses is two per year; with each upload taking approximately 16
hours at each site. In addition to the data extraction, FTDC staff will
complete 2 administrations (intake and discharge) of the NCFAS for each
family (approximately 267 families per year based on estimates
extrapolated from the CAM program). The NCFAS takes approximately .75
hours to complete per family per administration. The estimated total
cost of the time FTDC staff will spend completing data collection is
$15,952 per year (total number of staff hours, 720.5 hours, multiplied
by $22.14, the estimated average hourly wages for social work
professionals as published by the Bureau of Labor Statistics, 2013).
See Table 1.
Table 1--Annualized Hour Burden
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total hour
Form/instrument records record responses response burden
----------------------------------------------------------------------------------------------------------------
FTDC Form--Biannual extraction 10 2 20 16 320
of extant data x 10 grantees...
NCFAS--Administered twice for 267 2 534 .75 400.5
each family....................
-------------------------------------------------------------------------------
Total....................... 277 .............. 554 .............. 720.5
----------------------------------------------------------------------------------------------------------------
Note: The estimated response burden includes the extractions and uploads to the FTDC Form and administration the
North Carolina Family Assessment Form.
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 2-1057, One Choke Cherry Road, Rockville, MD 20857 or email her a
copy at summer.king@samhsa.hhs.gov. Written comments should be received
by June 9, 2015.
Summer King,
Statistician.
[FR Doc. 2015-08272 Filed 4-9-15; 8:45 am]
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