Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Notices 19331 

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 

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] 

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: 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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

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

Form/instrument Number of 

records 

Responses 

per record 

Total 

responses 

Hours per 

response 

Total hour 

burden 

FTDC Form—Biannual extraction of extant data x 10 

grantees ............................................................................ 10 2 20 16 320 

NCFAS—Administered twice for each family ...................... 267 2 534 .75 400.5 

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] 

BILLING CODE 4162–20–P 

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