Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 15221 

carcinomas. Its expression is limited in 

normal tissue, but is prevalent in 

malignant tumors throughout their 

development. This confined expression 

makes it an attractive target for cancer 

immunotherapy. 5T4 is often found in 

colorectal, ovarian, and gastric tumors 

and thus has been used as a prognostic 

aid for these cancers. In addition, its 

role in antibody-directed 

immunotherapy for delivering response 

modifiers to tumors has been studied 

using murine monoclonal antibodies 

(mAbs) and the cancer vaccine TroVax 

(currently in clinical trials for multiple 

solid tumors) targets 5T4. The present 

invention describes the identification 

and characterization of two fully human 

mAbs (m1001 and m1002) that bind to 

5T4. Since the mAbs are fully human, 

they could have less immunogenicity 

and better safety profiles than the 

existing mouse and humanized 

antibodies. 

The prospective start-up exclusive 

commercial license is being considered 

under the small business initiative 

launched on October 1, 2011 and will 

comply with the terms and conditions 

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

The prospective start-up exclusive 

commercial 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 part 404. 

Any additional, properly filed, and 

complete applications for a license in 

the field of use filed in response to this 

notice will be treated as objections to 

the grant of the contemplated exclusive 

commercial license. Comments and 

objections submitted 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: March 17, 2015. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2015–06488 Filed 3–20–15; 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: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Grantee Data Technical 

Assistance (GDTA) Training Needs 

Assessment Survey for SAMHSA 

Grantees-NEW 

In 2014, the Center for Behavioral 

Health Statistics and Quality (CBHSQ) 

funded the GDTA contract to provide 

training and technical assistance to all 

grantees receiving funding from the 

Center for Substance Abuse Treatment 

(CSAT), the Center for Mental Health 

Services (CMHS), and some grantees 

receiving funding from the Center for 

Substance Abuse Prevention (CSAP) 

that fall under the GDTA contract. This 

currently only includes discretionary 

grants but is expected to include block 

grants in future years. Training and 

technical assistance from the GDTA 

contract will focus on helping grantees 

use their Government and Performance 

Results Act of 1993 (GPRA) data for 

performance management and 

monitoring, and services improvement. 

The information being collected in this 

needs assessment will inform CBHSQ 

regarding the types of activities 

SAMHSA’s grants use their funding for 

and what types of training activities 

they would like to receive in the future. 

Description of Forms: Forms will 

include two questions. The first 

question asks about the services 

provided under the grant. Answer 

options include activities such as 

behavioral health care services, 

screening, prevention activities, and 

services to specific populations. The 

second question asks respondents to 

identify topics for training and technical 

assistance they would like to receive 

from a pre-populated list. Answer 

options include items such as data 

collection, data entry, and using data in 

creative ways. Both questions have an 

option for respondents to write-in an 

answer that is not included in the list. 

Description of Respondents: The 

respondent universe for this data 

collection effort is one Project Director 

from each SAMHSA-funded grants 

being served by the GDTA contract. This 

currently only includes discretionary 

grants but is expected to include block 

grants in future years. There are 

currently 2,670 SAMHSA-funded 

discretionary grants served by the GDTA 

contract, therefore this is the number of 

respondents expected for this data 

collection effort. 

TABLE 1—ANNUAL BURDEN ESTIMATE

Form name Number of 

respondents 

Annual 

responses per 

respondent 

Total annual 

responses 

Hours per 

response 

Total annual 

hour burden 

Grantee Needs Assessment ................................................ 2,670 1 2,670 0.1 267 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by April 22, 2015 to the 

SAMHSA Desk Officer at the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB). To ensure timely receipt of 

comments, and to avoid potential delays 

in OMB’s receipt and processing of mail 

sent through the U.S. Postal Service, 

commenters are encouraged to submit 

their comments to OMB via email to: 

OIRA_Submission@omb.eop.gov. 

Although commenters are encouraged to 

send their comments via email, 

commenters may also fax their 

comments to: 202–395–7285. 

Commenters may also mail them to: 

Office of Management and Budget, 

Office of Information and Regulatory 

Affairs, New Executive Office Building, 

Room 10102, Washington, DC 20503. 

Summer King, 

Statistician. 

[FR Doc. 2015–06532 Filed 3–20–15; 8:45 am] 

BILLING CODE 4162–20–P 

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