Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2951 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Defibrillating Device for MRI Procedures. 

Date: February 11, 2015. 

Time: 3:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals 

Place: National Institutes of Health, 6701 

Rockledge Drive, Room 7192, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Giuseppe Pintucci, Ph.D. 

Scientific Review Officer, Office of Scientific 

Review/DERA National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7192, Bethesda, MD 20892, 301–435–0287, 

Pintuccig@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: January 14, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–00820 Filed 1–20–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Mycobacterial genetics, 

biochemistry and drug discovery and 

development. 

Date: January 22, 2015. 

Time: 1:30 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Tera Bounds, DVM, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3214, 

MSC 7808, Bethesda, MD 20892, 301–435– 

2306, boundst@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: January 14, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–00821 Filed 1–20–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; NHLBI 

Mentored Clinical and Basic Science Review 

Committee. 

Date: February 19–20, 2015. 

Time: 10:30 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Westin Crystal City, 1800 

Jefferson Davis Highway, Arlington, VA 

22202. 

Contact Person: Keith A. Mintzer, Ph.D. 

Scientific Review Officer, Office of Scientific 

Review/DERA National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7186, Bethesda, MD 20892–7924, 301–594– 

7947, mintzerk@nhlbi.nih.gov 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: January 14, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–00819 Filed 1–20–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Start-up 

Exclusive License: Scopolamine for 

the Treatment of Depression and 

Anxiety 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR part 404, 

that the National Institutes of Health 

(NIH), Department of Health and Human 

Services, is contemplating the grant of a 

Start-Up Exclusive Patent License to 

Biohaven Pharmaceuticals Holding 

Company having its principal place of 

business in New Haven, Connecticut. 

The contemplated license would be for 

the inventions claimed in U.S. Utility 

Patent Number 8,859,585, issued 

October 14, 2014 (filed May 25, 2005), 

PCT Patent Application Number PCT/

US2006/19335, filed May 18, 2006, U.S. 

Patent Application Number 14/478,442, 

filed September 5, 2014, European 

Patent Number 1896025, issued 

December 28, 2011 (and validated in 

Germany, France, and the United 

Kingdom), and Canadian Patent Number 

2610025, issued July 22, 2014 (filed May 

28, 2006). In addition, inventions 

claimed in any future applications 

claiming priority to or benefit of these 

patents and patent applications would 

also be subject to any license granted 

pursuant to this Notice. 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. The 

territory of the prospective Start-Up 

Exclusive Patent License Agreement 

may be worldwide and the field of use 

may be limited to use of scopolamine 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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