Agency Information Collection Activities: Submission for OMB Review; Comment Request, 15221 [2015-06532]
Download as PDF
<![CDATA[
15221
Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
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
Number of
respondents
Annual
responses per
respondent
Total annual
responses
Hours per
response
Total annual
hour burden
Grantee Needs Assessment ................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Form name
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
VerDate Sep<11>2014
16:51 Mar 20, 2015
Jkt 235001
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 9990
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
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Page 15221]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06532]
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Form name Number of responses per Total annual Hours per Total annual
respondents respondent responses response 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
