2952 Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 

for treatment of neuropsychiatric 

indications. 

DATES: Only written comments and/or 

applications for a license that are 

received by the NIH Office of 

Technology Transfer on or before 

February 5, 2015 will be considered. 

ADDRESSES: Requests for a copy of the 

patent application, inquiries, comments 

and other materials relating to the 

contemplated Start-Up Exclusive license 

should be directed to: Susan Ano, Ph.D., 

Branch Chief, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

(301) 435–5515; Facsimile: (301) 402– 

0220; Email: anos@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: 

The subject invention describes the 

use of scopolamine for the treatment of 

depression, including major depressive 

disorder. Scopolamine is a known 

compound that has been employed in 

the treatment of nausea and motion 

sickness, as well as in conjunction with 

analgesics but the suitability of 

scopolamine for treating depression was 

unrecognized prior to this invention. 

An important feature of scopolamine, 

as a treatment for depression, is its fastacting nature. Currently available 

treatments can be ineffective in certain 

depression patients and typically do not 

show an effect in any patient until four 

weeks after first administration. 

However, preclinical data suggests that 

scopolamine has a rapid, wide-ranging 

and long lasting effect. This feature 

makes scopolamine highly desirable as 

a new treatment for depression. 

The prospective Start-Up Exclusive 

License Agreement is being considered 

under the small business initiative 

launched on October 1, 2011 and 

complies with the terms and conditions 

of 35 U.S.C. 209 and 37 CFR 404. The 

prospective exclusive license may be 

granted unless within fifteen (15) days 

from the date of this published notice, 

the NIH receives written evidence and 

argument that establishes that the grant 

of the license would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR 404. Complete applications 

for a license in the prospective field of 

use that are filed in response to this 

notice will be treated as objections to 

the grant of the contemplated Start-Up 

Exclusive Patent 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: January 13, 2015. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2015–00811 Filed 1–20–15; 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: Substance Abuse and 

Mental Health Data Archive (SAMHDA) 

Data Portal Applications—In Use 

Without Approval 

The Substance Abuse and Mental 

Health Administration (SAMHSA), 

Center for Behavioral Health Statistics 

and Quality (CBHSQ) funded the 

SAMHDA contract to promote the 

access and use of the nation’s substance 

abuse and mental health data on 

December 3rd, 1997. This includes 

public-use data files, file 

documentation, and access to restricteduse data files to support a better 

understanding of this critical area of 

public health. As a part of the SAMHDA 

initiative, the Data Portal was created 

and launched in January of 2013. The 

Data Portal provides researchers that 

need access to restricted-use data 

remote access to confidential data via a 

virtual desktop from a secure, approved 

location. Completions of an application 

process and project approval are 

required for Data Portal access. The 

information being collected in this 

needs assessment will provide CBHSQ 

the information required to determine 

whether a researcher is qualified to 

obtain access to the Data Portal, and 

restricted-use data collected under the 

Confidential Information Protection and 

Statistical Efficiency Act (CIPSEA). 

Description of Forms: Applications 

will include 18 questions and require 

the submission of CV’s. The application 

asks for information including the name 

of the organization that the researcher 

belongs to, name, title and contact 

information of the researcher and all 

subsequent researchers on the team, 

summaries of each applicants 

experience with restricted data and their 

CV’s, descriptions of the proposed 

research projects and methodology, 

what data is being requested and why, 

and any potential restricted variables 

that may be requested. 

Description of Respondents: The 

respondent universe for this data 

collection effort is researchers with a 

need for access to CBHSQ restricted-use 

data. These data include the National 

Survey on Drug Use and Health 

(NSDUH), the Drug Abuse Warning 

Network (DAWN), and NSDUH/DAWN 

supplement data. Respondents are 

researchers that have a need and want 

to provide this information. There are 

open calls for applications that occur 2 

times a year, and applications are 

accepted during a month long period. 

Anyone may apply. 

TABLE 1—ANNUAL BURDEN ESTIMATE

Form name Number of 

respondents 

Annual 

responses per 

respondent 

Total annual 

responses 

Hours per 

response 

Total annual 

hour burden 

Data Portal Application Needs Assessment ........................ 100 1 100 5 500 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2953 

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 March 23, 2015. 

Summer King, 

Statistician. 

[FR Doc. 2015–00843 Filed 1–20–15; 8:45 am] 

BILLING CODE 4162–20–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: National Evaluation 

of the Comprehensive Community 

Mental Health Services for Children 

and Their Families Program: Phase VI 

(OMB No. 0930–0307)—Revision 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Center of Mental Health 

Services is responsible for the national 

evaluation of the Comprehensive 

Community Mental Health Services for 

Children and Their Families Program 

(Children’s Mental Health Initiative— 

CMHI) that will collect data on child 

mental health outcomes, family life, and 

service system development. Data will 

be collected on nine (9) service systems, 

and approximately 2,106 children and 

families and providers/administrators, 

using 26 instruments. Data collection 

will be decreased by 26,960 hours due 

to program changes resulting from the 

closing of 19 communities funded in FY 

2009 that no longer require data 

collection and data collection for the 

Sector and Comparison Study. 

Data collection for this evaluation will 

be conducted over the next 3-year 

period. Child and family outcomes of 

interest will be collected at intake and 

at 6-month follow-up. The individual 

families will participate in the study for 

the remaining 12 months. The outcome 

measures include the following: Child 

symptomatology and functioning, 

family functioning, satisfaction, and 

caregiver strain. The service system data 

will be collected every 6 months during 

the remaining 3 years of the evaluation. 

Service utilization and cost data will be 

tracked and submitted to the national 

evaluation every 6 months using two 

tools—the Flex Fund Tool and the 

Services and Costs Data Tool—to 

estimate average cost of treatment per 

child, distribution of costs, and 

allocation of costs across service 

categories. Service delivery and system 

variables of interest include the 

following: Maturity of system of care 

development in funded system of care 

communities, adherence to the system 

of care program model, and client 

service experience. Internet-based 

technology such as data entry and 

management tools will be used in this 

evaluation. The measures of the national 

evaluation address annual 

Congressional reporting requirements of 

the program’s authorizing legislation, 

and the national outcome measures for 

mental health programs as currently 

established by SAMHSA. 

Changes: 

The previously approved Phase VI 

evaluation is composed of six core study 

components: (1) The System of Care 

Assessment that documents the 

development of systems of care through 

site visits conducted every 12–18 

months; (2) the Cross-Sectional 

Descriptive Study that collects 

descriptive data on all children and 

families who enter the CMHS-funded 

systems of care throughout the funding 

period; (3) the Child and Family 

Outcome Study that collects data 

longitudinally on child clinical and 

functional status, and family outcomes; 

(4) the Service Experience Study that 

collects data on family experience and 

satisfaction with services from a sample 

of children and families; (5) the Services 

and Costs Study that assesses the costs 

and cost-effectiveness of system of care 

services; and (6) the Sustainability 

Study, as well as and three special 

studies: the Alumni Networking Study, 

the Continuous Quality Improvement 

(CQI) Initiative Evaluation, and the 

Sector and Comparison Study. Earlier 

revisions eliminated one of the core 

studies, the Sustainability Study, and 

two of the special studies: the Alumni 

Networking Study and the Continuous 

Quality Improvement (CQI) Initiative 

Evaluation. 

This revision requests the elimination 

of the Sector and Comparison Study. 

The eliminated studies have provided 

data to the program and are no longer 

needed. The Sector and Comparison 

Study was conducted with a subsample 

of the FY 2008-funded CA awardees, 

which are not included in this revision. 

The average annual respondent 

burden is estimated below. The estimate 

reflects the average number of 

respondents in each respondent 

category, the average number of 

responses per respondent per year, the 

average length of time it will take to 

complete each response, and the total 

average annual burden for each category 

of respondent, and for all categories of 

respondents combined. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES