Agency Information Collection Activities: Proposed Collection; Comment Request, 26773-26774 [2012-10882]

Download as PDF 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: VerDate Mar<15>2010 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