Agency Information Collection Activities: Proposed Collection; Comment Request, 26773-26774 [2012-10882]
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Federal Register / Vol. 77, No. 88 / Monday, May 7, 2012 / Notices
FOR FURTHER INFORMATION CONTACT:
Requests for a copy of the patent
application, inquiries, and comments
relating to the contemplated license
should be directed to: Susan Ano, Ph.D.,
Branch Chief, IDME, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Email: anos@mail.nih.gov; Telephone:
301–435–5515; Facsimile: 301–402–
0220.
The
invention relates to a drug delivery
system, compositions of, methods of
making the drug delivery system, and
methods of use as a drug delivery
platform. Ocular therapeutics that
require repeated intravitreal injections
are associated with eye infections,
retinal detachment, hemorrhaging,
endophthalmitis, and/or cataracts, while
topical solutions that require daily
application are associated with patient
non-compliance. This technology
describes a drug delivery platform that
can be designed to deliver therapeutics
to the eye over months to years.
Therefore, this technology can be used
to design a therapeutic implant that
reduces or eliminates patient noncompliance and/or improve patient
safety. The therapeutic implant has the
following advantages: (a) It is
bioerodible which makes it more
noninvasive than repeated intravitreal
injections and non-bioerodible
implants; (b) has a dual release system
that allows the release of two distinct
therapeutics or a single therapeutic at
different rates; (c) prolongs the
therapeutic dose of an agent across the
surface of the eye compared to topical
solutions; (d) reduces the risk of
additional eye damage compared to
repeated intravitreal injections; (e)
dispenses a therapeutic agent over a
long period of time resulting in increase
patient compliance and patient health;
and (f) is associated with reduced
systemic drug side-effects compared to
drugs applied systemically. Data are
available for rodents, rabbits, dogs, and
horses.
The field of use may be limited to
‘‘Episcleral Therapeutic Implant for
Ophthalmic Diseases’’.
The prospective worldwide exclusive
license will be royalty bearing and will
comply with the terms and conditions
of 35 U.S.C. 209 and 37 CFR 404.7. The
prospective exclusive license may be
granted unless, within fifteen (15) days
from the date of this published Notice,
NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
sroberts on DSK5SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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18:11 May 04, 2012
Jkt 226001
with the requirements of 35 U.S.C. 209
and 37 CFR 404.7.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: May 1, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–10836 Filed 5–4–12; 8:45 am]
BILLING CODE 4140–01–P
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: Healthy Transitions
Initiative Cross-Site Evaluation—NEW
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center of Mental Health
Services is responsible for the cross-site
evaluation of the Cooperative
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
26773
Agreements for State/Community
Partnerships to Integrate Services and
Supports for Youth and Young Adults
16–25 with Serious Emotional
Disturbances (SED) or Serious Mental
Illness (SMI), and Their Families
(Healthy Transitions Initiative—HTI)
that will collect data on program
implementation and youth and young
adult outcomes in the areas of
education, employment, housing,
mental health and co-occurring
disorders, and involvement with the
juvenile and criminal justice systems.
This cross-site evaluation design
includes a process and an outcome
evaluation and data will be collected
over a 3-year period from 7 grantee sites.
The cross-site evaluation is designed
to address the following questions.
Process Evaluation Questions
1. How closely does implementation
match the plan proposed in the grant?
2. What types of deviation from the
plan occur?
3. What effect do the deviations have
on the planned intervention and
performance assessment?
4. What facilitates a successful
transition between youth and adult
systems?
5. Is there a change from a ‘‘youthguided’’ model to a ‘‘youth and young
adult consumer-driven’’ model?
6. What is the extent of interagency
coordination and collaboration?
7. How are state and local-level
systems changing in response to the HTI
implementation? How does state and
local-level policy change affect the
implementation of the Initiative?
8. Who provides services (i.e.,
program staff, agency site)?
9. What services are being provided
(i.e., modality, type, intensity,
duration)?
10. Is there a viable cultural and
linguistic competence plan?
11. What are the individual
characteristics of the youth and young
adults (i.e., who is being served)?
12. In what settings (i.e., system,
community) are they being served?
Outcome Evaluation Questions
1. What is the effect of the HTI
intervention on the participants?
2. What is the effect of the HTI
intervention, compared to a sample of
similar young adults not participating in
the HTI intervention?
3. What program factors are associated
with the observed outcomes?
4. What individual factors are
associated with the observed outcomes?
5. How durable are the effects over 24
months?
E:\FR\FM\07MYN1.SGM
07MYN1
26774
Federal Register / Vol. 77, No. 88 / Monday, May 7, 2012 / Notices
Process Evaluation
The process evaluation is designed to
assess the fidelity of grantees to
implement their proposed program
model, and consists of young person
focus groups, young person surveys,
youth mentor focus groups, transitional
program personnel interviews and
surveys, and local and state
administrator interviews. Process
evaluation data will be collected in two
waves during FY 2012 and during FY
2014 and, with the exception of the state
administrator interviews, participants
are not expected to participate more
than one time during the 2 waves of
data collection.
Outcome Evaluation
The outcome evaluation is designed
to assess outcomes of youth and young
adults in regards to education,
employment, housing, mental health
and co-occurring disorders, and
involvement with the juvenile and
criminal justice systems. The outcome
evaluation will utilize both an enhanced
and standard data collection and a
longitudinal cohort design, and will
include a comparative study to assess
the effectiveness of HTI relative to a
similar sample of young persons who
did not receive HTI services. In the
standard data collection protocol,
outcome data will be collected for each
HTI young adult participant, at a
minimum of, at baseline at least every
6 months for up to 24 months for as long
as the participant remains in HTI
services. Enhanced outcome data will be
collected on a subsample of young
adults at 6 month intervals. The
enhanced protocol will continue even
after the young person from the
subsample has left or has been
discharged from HTI services, for up to
24 months. The baseline and follow up
outcome instruments include the
following key indicators: Demographic
information, service use, education,
employment/vocational training,
housing and living situation, clinical
outcomes, behavioral and other health,
trauma-related experiences, life skills,
parenting skills and supports,
involvement with juvenile or criminal
justice systems, and social and peer
relationships. While participants are
enrolled in HTI services, these data
collected by the HTI grantees as
specified in the RFA.
The HTI Data Center (HTI DC) will be
developed for data collection and
management. The HTI DC will be a
secure Web site that allows uploading of
data, real-time access to data by
grantees, and production of automated
reports for the sites. It is flexible for
local use and simplifies the
management, monitoring, and reporting
of data.
The summary burden reflects the
distinct number of respondents, total
annual burden, and total hourly cost of
the study.
SUMMARY BURDEN TABLE
Average annual number
responses/
respondent
Number of
distinct
respondents
Total annual
number of
responses
Average 3year burden
per response
(hours)
Total annual
burden
(hours)
Hourly wage
cost
a $7.25
Total hourly
cost*
Young Persons ............
Youth Mentors ..............
Transitional Program
Personnel .................
Local Administrators ....
State Administrators .....
320
84
1.10
0.33
796
28
1.55
1.25
547
35
49
21
7
0.33
0.67
0.67
23
14
9
1.41
1.50
0.54
23
21
3
d 22.69
e 23.54
351
476
220
Total Summary .....
481
3
871
........................
629
........................
5,389
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 8–1099, One Choke Cherry Road,
Rockville, MD 20857 or email a copy to
summer.king@samhsa.hhs.gov. Written
comments must be received before 60
days after the date of the publication in
the Federal Register.
Summer King,
Statistician.
[FR Doc. 2012–10882 Filed 5–4–12; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
sroberts on DSK5SPTVN1PROD with NOTICES
[Docket No. DHS–2012–0021]
Homeland Security Advisory Council
The Office of Policy, DHS.
Notice of partially closed federal
advisory committee meeting.
AGENCY:
ACTION:
The Homeland Security
Advisory Council (HSAC) will meet in
SUMMARY:
VerDate Mar<15>2010
18:11 May 04, 2012
Jkt 226001
person and members of the public may
participate by conference call on May
24, 2012. The meeting will be partially
closed to the public.
DATES: The HSAC will meet on
Thursday, May 24, 2012, from 9:00 a.m.
to 3:00 p.m. EDT. The portion of the
meeting from 9:00 a.m. to 12:45 p.m.
will be closed to the public. The
meeting will be open to the public from
1:00 p.m. to 3:00 p.m.
ADDRESSES: Written comments must be
submitted and received by May 22,
2012. Comments must be identified by
Docket No. DHS–2012–0021 and may be
submitted by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: HSAC@dhs.gov. Include
docket number in the subject line of the
message.
• Fax: (202) 282–9207.
• Mail: Homeland Security Advisory
Council, Department of Homeland
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
b 10.74
c 15.24
$3966
376
Security, Mailstop 0450, 245 Murray
Lane SW., Washington, DC 20528.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and DHS–2012–
0021, the docket number for this action.
Comments received will be posted
without alteration at https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received by the DHS
Homeland Security Advisory Council,
go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
HSAC Staff at hsac@dhs.gov or 202–
447–3135.
SUPPLEMENTARY INFORMATION: Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C. App.
The HSAC provides organizationally
independent, strategic, timely, specific
and actionable advice and
recommendations for the consideration
of the Secretary of the Department of
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26773-26774]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10882]
-----------------------------------------------------------------------
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: Healthy Transitions Initiative Cross-Site
Evaluation--NEW
The Substance Abuse and Mental Health Services Administration
(SAMHSA), Center of Mental Health Services is responsible for the
cross-site evaluation of the Cooperative Agreements for State/Community
Partnerships to Integrate Services and Supports for Youth and Young
Adults 16-25 with Serious Emotional Disturbances (SED) or Serious
Mental Illness (SMI), and Their Families (Healthy Transitions
Initiative--HTI) that will collect data on program implementation and
youth and young adult outcomes in the areas of education, employment,
housing, mental health and co-occurring disorders, and involvement with
the juvenile and criminal justice systems. This cross-site evaluation
design includes a process and an outcome evaluation and data will be
collected over a 3-year period from 7 grantee sites.
The cross-site evaluation is designed to address the following
questions.
Process Evaluation Questions
1. How closely does implementation match the plan proposed in the
grant?
2. What types of deviation from the plan occur?
3. What effect do the deviations have on the planned intervention
and performance assessment?
4. What facilitates a successful transition between youth and adult
systems?
5. Is there a change from a ``youth-guided'' model to a ``youth and
young adult consumer-driven'' model?
6. What is the extent of interagency coordination and
collaboration?
7. How are state and local-level systems changing in response to
the HTI implementation? How does state and local-level policy change
affect the implementation of the Initiative?
8. Who provides services (i.e., program staff, agency site)?
9. What services are being provided (i.e., modality, type,
intensity, duration)?
10. Is there a viable cultural and linguistic competence plan?
11. What are the individual characteristics of the youth and young
adults (i.e., who is being served)?
12. In what settings (i.e., system, community) are they being
served?
Outcome Evaluation Questions
1. What is the effect of the HTI intervention on the participants?
2. What is the effect of the HTI intervention, compared to a sample
of similar young adults not participating in the HTI intervention?
3. What program factors are associated with the observed outcomes?
4. What individual factors are associated with the observed
outcomes?
5. How durable are the effects over 24 months?
[[Page 26774]]
Process Evaluation
The process evaluation is designed to assess the fidelity of
grantees to implement their proposed program model, and consists of
young person focus groups, young person surveys, youth mentor focus
groups, transitional program personnel interviews and surveys, and
local and state administrator interviews. Process evaluation data will
be collected in two waves during FY 2012 and during FY 2014 and, with
the exception of the state administrator interviews, participants are
not expected to participate more than one time during the 2 waves of
data collection.
Outcome Evaluation
The outcome evaluation is designed to assess outcomes of youth and
young adults in regards to education, employment, housing, mental
health and co-occurring disorders, and involvement with the juvenile
and criminal justice systems. The outcome evaluation will utilize both
an enhanced and standard data collection and a longitudinal cohort
design, and will include a comparative study to assess the
effectiveness of HTI relative to a similar sample of young persons who
did not receive HTI services. In the standard data collection protocol,
outcome data will be collected for each HTI young adult participant, at
a minimum of, at baseline at least every 6 months for up to 24 months
for as long as the participant remains in HTI services. Enhanced
outcome data will be collected on a subsample of young adults at 6
month intervals. The enhanced protocol will continue even after the
young person from the subsample has left or has been discharged from
HTI services, for up to 24 months. The baseline and follow up outcome
instruments include the following key indicators: Demographic
information, service use, education, employment/vocational training,
housing and living situation, clinical outcomes, behavioral and other
health, trauma-related experiences, life skills, parenting skills and
supports, involvement with juvenile or criminal justice systems, and
social and peer relationships. While participants are enrolled in HTI
services, these data collected by the HTI grantees as specified in the
RFA.
The HTI Data Center (HTI DC) will be developed for data collection
and management. The HTI DC will be a secure Web site that allows
uploading of data, real-time access to data by grantees, and production
of automated reports for the sites. It is flexible for local use and
simplifies the management, monitoring, and reporting of data.
The summary burden reflects the distinct number of respondents,
total annual burden, and total hourly cost of the study.
Summary Burden Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average annual Average 3-year
Number of number Total annual burden per Total annual Hourly wage Total hourly
distinct responses/ number of response burden cost cost*
respondents respondent responses (hours) (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Young Persons........................... 320 1.10 796 1.55 547 \a\ $7.25 $3966
Youth Mentors........................... 84 0.33 28 1.25 35 \b\ 10.74 376
Transitional Program Personnel.......... 49 0.33 23 1.41 23 \c\ 15.24 351
Local Administrators.................... 21 0.67 14 1.50 21 \d\ 22.69 476
State Administrators.................... 7 0.67 9 0.54 3 \e\ 23.54 220
---------------------------------------------------------------------------------------------------------------
Total Summary....................... 481 3 871 .............. 629 .............. 5,389
--------------------------------------------------------------------------------------------------------------------------------------------------------
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 8-1099, One Choke Cherry Road, Rockville, MD 20857 or email a copy
to summer.king@samhsa.hhs.gov. Written comments must be received before
60 days after the date of the publication in the Federal Register.
Summer King,
Statistician.
[FR Doc. 2012-10882 Filed 5-4-12; 8:45 am]
BILLING CODE 4162-20-P
