Submission for OMB Review; 30-Day Comment Request: Generic Clearance To Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), 18038-18039 [2014-07105]
Download as PDF
<![CDATA[
18038
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
Dated: March 11, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–06999 Filed 3–28–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Generic Clearance
To Support the Safe to Sleep
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
(NICHD)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Child Health and Human
Development, the National Institutes of
Health, has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on December 30, 2013, pages
79472–79473 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institute of Child Health and Human
Development, National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:10 Mar 28, 2014
Jkt 232001
To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Dr. Sarah L. Glavin, Deputy
Director, Office of Science Policy,
Analysis and Communication, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
National Institutes of Health, 31 Center
Drive, Room 2A18, Bethesda, Maryland
20892, or call a non-toll free number
(301) 496–1877 or Email your request,
including your address to glavins@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Generic
Clearance to Support the Safe to Sleep
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
(NICHD), 0925—NEW, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This is a request for a new
generic clearance that would be used for
submissions specific to the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD) Safe to Sleep (STS) public
education campaign. Submissions for
the STS campaign will be used to assess
the understanding and reach of STS
campaign materials and messages, and
to monitor and improve campaign
activities such as training workshops
and overall implementation. The
purpose of this information collection is
to monitor and modify campaign
activities, to plan future campaign
activities, to develop messages and
materials, and to develop distribution
and outreach strategies that are effective
at communicating their message to bring
about the intended response, awareness,
and/or behavioral change for the target
audiences. This generic clearance will
enable the NICHD to: (1) More
efficiently assess the implementation of
campaign activities; (2) better
understand the target audiences’
knowledge, attitudes, and beliefs toward
STS messages and materials; (3) better
understand how the campaign activities
have influenced the target audiences’
behaviors and practices; and (4) monitor
and improve activities such as trainings,
and material/message development.
Having a way to gather feedback on the
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
STS campaign activities is critical to
assessing the reach and effect of
campaign efforts. Data collected for the
campaign can inform where future STS
campaign resources can produce the
most meaningful results.
Data collected for the STS campaign
generic clearance will be used by a
number of audiences, including STS
campaign staff, NICHD leadership, STS
campaign collaborators, Federal Sudden
and Unexpected Infant Deaths (SUID)/
Sudden Infant Death Syndrome (SIDS)
Workgroup members, SUID/SIDS
stakeholders, clinical and maternal/
child health professionals, parents and
caretakers, and the general public.
These audiences may use the
information collections to: (1) Develop
new campaign messages, materials, and/
or training curricula; (2) monitor and
improve campaign activities; (3) make
decisions about campaign activities; (4)
inform current campaign activities; and
(5) inform and/or change practices and
behaviors of program participants.
Examples of the types of information
collections that could be included under
this generic clearance include: Focus
groups and in-depth interviews with
parents/caregivers and/or health
professionals to get feedback on
distribution and outreach activities,
and/or campaign messages; and Surveys
with parents/caregivers and/or health
professionals to: (1) Assess the
usefulness of the new STS campaign
materials, including print and on-line
materials and a video, (2) track outreach
experiences of program participants, (3)
assess training participants’ changes in
knowledge related to safe infant sleep
behavior and implementation of
outreach methods taught, and (4) assess
program participants’ resource needs.
The sub-studies for this generic will
be small scale, designed to obtain
results frequently and quickly to guide
campaign development and
implementation, inform campaign
direction, and be used internally for
campaign management purposes.
NICHD’s current scope and capacity for
STS generic sub-studies is non-existent
and this request would fill this gap.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
3,000.
Estimated Annualized Burden Hours
E:\FR\FM\31MRN1.SGM
31MRN1
18039
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
TABLE 1—ESTIMATES FOR ANNUAL BURDEN HOURS
Type of data collection
instrument
Number of
respondents
Frequency of
response
Average time
per response
Annual hour
burden
Focus Groups ..................................................................................................
Pre/Post Test ...................................................................................................
Survey ..............................................................................................................
Interview ...........................................................................................................
Tracking/Feedback Form .................................................................................
500
2,500
2,500
500
1,500
1
1
1
1
1
1
15/60
15/60
1
30/60
500
625
625
500
750
Total ..........................................................................................................
7,500
........................
........................
3,000
Dated: March 21, 2014.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis, and Communications, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, National
Institutes of Health.
[FR Doc. 2014–07105 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of a Single
Domain Human Anti-Mesothelin
Monoclonal Antibody for the Treatment
of Human Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive start-up option license to
practice the inventions embodied in
U.S. Patent Application 61/706,396
entitled ‘‘Mesothelin Antibodies and
Methods for Eliciting Potent Antitumor
Activity’’ [HHS Ref. E–236–2012/0–US–
01], PCT Application PCT/US2013/
059883 entitled ‘‘Mesothelin Antibodies
and Methods for Eliciting Potent
Antitumor Activity’’ [HHS Ref. E–236–
2012/0–PCT–02], and all related
continuing and foreign patents/patent
applications for the technology family,
to H2Bio, Inc. The patent rights in these
inventions have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive start-up
option licensed territory may be
worldwide, and the field of use may be
limited to:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
The use of the monoclonal antibody SD1
(and glycoengineered variants thereof) as an
antibody therapy for the treatment of
mesothelioma, pancreatic cancer, ovarian
cancer and lung adenocarcinoma. The
VerDate Mar<15>2010
18:10 Mar 28, 2014
Jkt 232001
Licensed Field of Use explicitly excludes the
use of the antibody in the form of an
immunoconjugate, including, but not limited
to, immunotoxins.
Upon the expiration or termination of
the exclusive start-up option license,
H2Bio, Inc. will have the exclusive right
to execute an exclusive
commercialization license which will
supersede and replace the exclusive
start-up option license with no greater
field of use and territory than granted in
the exclusive start-up option license.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
15, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4632; Facsimile: (301) 402–
0220; Email: lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns a monoclonal
antibody and methods of using the
antibody for the treatment of
mesothelin-expressing cancers,
including mesothelioma, lung cancer,
ovarian cancer and pancreatic cancer.
The specific antibody covered by this
technology is designated SD1, which is
a single domain, fully human
monoclonal antibody against
mesothelin.
Mesothelin is a cell surface antigen
that is preferentially expressed on
certain types of cancer cells. The SD1
antibody can selectively bind to these
cancer cells and induce cell death while
leaving healthy, essential cells
unharmed. This can result in an
effective therapeutic strategy with fewer
side effects due to less non-specific
killing of cells.
The prospective exclusive start-up
option license will be royalty bearing
and will comply with the terms and
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
conditions of 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive
start-up option license may be granted
unless 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
within fifteen (15) days from the date of
this published notice.
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
start-up option 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 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–07022 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Multivalent Vaccines for
Rabies Virus and Ebola and Marburg
(Filoviruses)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health (NIH),
Department of Health and Human
Services (HHS), is contemplating the
grant of a an exclusive license to
practice the following invention as
embodied in the following patent
applications: E–032–2011/0, Blaney et
al., ‘‘Multivalent Vaccines for Rabies
Virus and Filoviruses,’’ U.S. Patent
Application Number 61/439,046, filed
SUMMARY:
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18038-18039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: Generic
Clearance To Support the Safe to Sleep Campaign at the Eunice Kennedy
Shriver National Institute for Child Health and Human Development
(NICHD)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Child Health and Human
Development, the National Institutes of Health, has submitted to the
Office of Management and Budget (OMB) a request for review and approval
of the information collection listed below. This proposed information
collection was previously published in the Federal Register on December
30, 2013, pages 79472-79473 and allowed 60-days for public comment. No
public comments were received. The purpose of this notice is to allow
an additional 30 days for public comment. The National Institute of
Child Health and Human Development, National Institutes of Health, may
not conduct or sponsor, and the respondent is not required to respond
to, an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, or request more information on the
proposed project, contact: Dr. Sarah L. Glavin, Deputy Director, Office
of Science Policy, Analysis and Communication, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, National
Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland
20892, or call a non-toll free number (301) 496-1877 or Email your
request, including your address to glavins@mail.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Proposed Collection: Generic Clearance to Support the Safe to Sleep
Campaign at the Eunice Kennedy Shriver National Institute for Child
Health and Human Development (NICHD), 0925--NEW, Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD),
National Institutes of Health (NIH).
Need and Use of Information Collection: This is a request for a new
generic clearance that would be used for submissions specific to the
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) Safe to Sleep (STS) public education campaign.
Submissions for the STS campaign will be used to assess the
understanding and reach of STS campaign materials and messages, and to
monitor and improve campaign activities such as training workshops and
overall implementation. The purpose of this information collection is
to monitor and modify campaign activities, to plan future campaign
activities, to develop messages and materials, and to develop
distribution and outreach strategies that are effective at
communicating their message to bring about the intended response,
awareness, and/or behavioral change for the target audiences. This
generic clearance will enable the NICHD to: (1) More efficiently assess
the implementation of campaign activities; (2) better understand the
target audiences' knowledge, attitudes, and beliefs toward STS messages
and materials; (3) better understand how the campaign activities have
influenced the target audiences' behaviors and practices; and (4)
monitor and improve activities such as trainings, and material/message
development. Having a way to gather feedback on the STS campaign
activities is critical to assessing the reach and effect of campaign
efforts. Data collected for the campaign can inform where future STS
campaign resources can produce the most meaningful results.
Data collected for the STS campaign generic clearance will be used
by a number of audiences, including STS campaign staff, NICHD
leadership, STS campaign collaborators, Federal Sudden and Unexpected
Infant Deaths (SUID)/Sudden Infant Death Syndrome (SIDS) Workgroup
members, SUID/SIDS stakeholders, clinical and maternal/child health
professionals, parents and caretakers, and the general public. These
audiences may use the information collections to: (1) Develop new
campaign messages, materials, and/or training curricula; (2) monitor
and improve campaign activities; (3) make decisions about campaign
activities; (4) inform current campaign activities; and (5) inform and/
or change practices and behaviors of program participants.
Examples of the types of information collections that could be
included under this generic clearance include: Focus groups and in-
depth interviews with parents/caregivers and/or health professionals to
get feedback on distribution and outreach activities, and/or campaign
messages; and Surveys with parents/caregivers and/or health
professionals to: (1) Assess the usefulness of the new STS campaign
materials, including print and on-line materials and a video, (2) track
outreach experiences of program participants, (3) assess training
participants' changes in knowledge related to safe infant sleep
behavior and implementation of outreach methods taught, and (4) assess
program participants' resource needs.
The sub-studies for this generic will be small scale, designed to
obtain results frequently and quickly to guide campaign development and
implementation, inform campaign direction, and be used internally for
campaign management purposes. NICHD's current scope and capacity for
STS generic sub-studies is non-existent and this request would fill
this gap.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 3,000.
Estimated Annualized Burden Hours
[[Page 18039]]
Table 1--Estimates for Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of data collection instrument respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Focus Groups.................................... 500 1 1 500
Pre/Post Test................................... 2,500 1 15/60 625
Survey.......................................... 2,500 1 15/60 625
Interview....................................... 500 1 1 500
Tracking/Feedback Form.......................... 1,500 1 30/60 750
---------------------------------------------------------------
Total....................................... 7,500 .............. .............. 3,000
----------------------------------------------------------------------------------------------------------------
Dated: March 21, 2014.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis, and
Communications, Eunice Kennedy Shriver National Institute of Child
Health and Human Development, National Institutes of Health.
[FR Doc. 2014-07105 Filed 3-28-14; 8:45 am]
BILLING CODE 4140-01-P
