Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 31245-31246 [2016-11672]
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31245
Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
Comments on this Information
Collection Request must be received no
later than July 18, 2016.
DATES:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, 5600 Fishers
Lane, Rockville, MD 20857.
ADDRESSES:
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
FOR FURTHER INFORMATION CONTACT:
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Stem Cell Therapeutic Outcomes
Database OMB No. 0915–0310—
Revision.
Abstract: The Stem Cell Therapeutic
and Research Act of 2005, Public Law
(P.L.) 109–129, as amended by the Stem
Cell Therapeutic and Research
Reauthorization Act of 2015, P.L. 114–
104 (the Act), provides for the collection
and maintenance of human blood stem
cells for the treatment of patients and
research. HRSA’s Healthcare Systems
Bureau has established the Stem Cell
Therapeutic Outcomes Database.
Operation of this database necessitates
certain record keeping and reporting
requirements to perform the functions
related to hematopoietic stem cell
transplantation under contract to the
U.S. Department of Health and Human
Services (HHS). The Act requires the
Secretary to contract for the
establishment and maintenance of
information related to patients who
have received stem cell therapeutic
products and to do so using a
standardized, electronic format. Data is
collected from transplant centers by the
Center for International Blood and
Marrow Transplant Research and is
used for ongoing analysis of transplant
outcomes. The increase in burden is due
to an increase in the annual number of
Number of
respondents
Responses
per
respondent
transplants and increasing survivorship
after transplantation.
Need and Proposed Use of the
Information: HRSA uses the information
to carry out its statutory responsibilities.
Information is needed to monitor the
clinical status of transplantation and
provide the Secretary of HHS with an
annual report of transplant centerspecific survival data.
Likely Respondents: Transplant
Centers.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized Burden
Hours:
Total
responses
Hours per
response
Total burden
hours
Baseline Pre-Transplant Essential Data (TED) ...................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-Day Post-TED ...............................................................
6-Month Post-TED ...............................................................
12-Month Post-TED .............................................................
Annual Post-TED .................................................................
200
44
8,800
1.15
10,120
200
200
200
200
200
33
44
36
32
110
6,600
8,800
7,200
6,400
22,000
1
1
1.15
1.15
1.15
6,600
8,800
8,280
7,360
25,300
* Total ............................................................................
200
........................
59,800
........................
66,460
sradovich on DSK3TPTVN1PROD with NOTICES
* The Total of 200 is the number of centers completing the form. The same group of 200 centers completes each of the forms.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–11674 Filed 5–17–16; 8:45 am]
BILLING CODE 4165–15–P
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17:10 May 17, 2016
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
SUMMARY:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
Comments on this ICR should be
received no later than June 17, 2016.
DATES:
Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
ADDRESSES:
E:\FR\FM\18MYN1.SGM
18MYN1
31246
Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Network Allied Health Training
Program Performance Improvement
Measurement System (PIMS)
OMB No.: 0906–xxxx—NEW.
Abstract: The Rural Network Allied
Health Training Program will support
the development of formal, mature rural
health networks that focus on activities
that achieve efficiencies, expand access
to, coordinate and improve the quality
of essential health care services, and
strengthen the rural health care system
as a whole. This purpose will be
achieved through the recruitment,
clinical training, and retention of allied
health professionals.
This program will further support
integrated rural health networks that
can partner with local community
colleges and other accredited
educational institutions (such as
vocational and technical colleges) to
develop formal clinical training
programs.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to the Federal Office of Rural
Health Policy (FORHP), including: (a)
Access to care; (b) population
demographics; (c) staffing; (d)
consortium/network; (e) sustainability;
and (f) project specific domains. Several
measures will be used for this program.
All measures will speak to FORHP’s
progress toward meeting the goals.
Number of
respondents
Form name
Number of
responses per
respondent
Likely Respondents: The respondents
are recipients of the Rural Network
Allied Health Training Program grant
funding.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden
Hours:
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Rural Network Allied Health Training Program Performance Measures .................................................................
10
1
10
6.55
65.5
Total ..............................................................................
10
........................
10
........................
65.5
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–11672 Filed 5–17–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: The Development of an AntiGPC3 Chimeric Antigen Receptor
(CAR) Based on HN3 for the Treatment
of Human Cancers
National Institutes of Health,
Public Health Service, Department of
Health and Human Services.
AGENCY:
sradovich on DSK3TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
license to practice the inventions
embodied in:
SUMMARY:
VerDate Sep<11>2014
17:10 May 17, 2016
Jkt 238001
Intellectual Property: U.S. Provisional
Patent Application 61/654,232 entitled
‘‘High-affinity Monoclonal Antibodies
To Glypican-3 And Use Thereof’’ [HHS
Ref. E–136–2012/0–US–01]; PCT Patent
Application PCT/US2013/043633
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–
PCT–02]; Chinese Patent Application
201380039993.7 entitled ‘‘High-affinity
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012/0–CN–03]; Japanese Patent
Application 2015–515243 entitled
‘‘High-affinity Monoclonal Antibodies
To Glypican-3 And Use Thereof’’ [HHS
Ref. E–136–2012/0–JP–04]; South Korea
Patent Application 10–2014–7037046
entitled ‘‘High-affinity Monoclonal
Antibodies To Glypican-3 And Use
Thereof’’ [HHS Ref. E–136–2012/0–KR–
05]; Singapore Patent Application
11201407972R entitled ‘‘High-affinity
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012/0–SG–06]; United States Patent
Application 14/403,896 entitled ‘‘Highaffinity Monoclonal Antibodies To
Glypican-3 And Use Thereof’’ [HHS Ref.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
E–136–2012/0–US–07]; and all
continuing U.S. and foreign patents/
patent applications for the technology
family, to Lentigen Technology, Inc.
The patent rights to these inventions
have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive licensed
territory may be the United States,
Australia, Canada, the European Union,
Russia, China, Hong Kong, Japan,
Taiwan, South Korea and Singapore,
and the field of use may be limited to:
‘‘The development of a glypican-3
(GPC3) chimeric antigen receptor (CAR)based immunotherapy using autologous
(meaning one individual is both the
donor and the recipient) primary human
lymphocytes (T cells or NK cells)
transfected with a lentiviral or retroviral
vector, wherein the vector expresses a
CAR having (1) a single antigen
specificity and (2) comprising at least:
(a) the complementary determining
region (CDR) sequences of the anti-GPC3
antibody known as HN3; and (b) a T cell
signaling domain; for the prophylaxis
and treatment of GPC3-expressing
cancers.’’
E:\FR\FM\18MYN1.SGM
18MYN1
]]>Agencies
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31245-31246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11672]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than June 17,
2016.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to
[[Page 31246]]
OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Rural Network Allied Health
Training Program Performance Improvement Measurement System (PIMS)
OMB No.: 0906-xxxx--NEW.
Abstract: The Rural Network Allied Health Training Program will
support the development of formal, mature rural health networks that
focus on activities that achieve efficiencies, expand access to,
coordinate and improve the quality of essential health care services,
and strengthen the rural health care system as a whole. This purpose
will be achieved through the recruitment, clinical training, and
retention of allied health professionals.
This program will further support integrated rural health networks
that can partner with local community colleges and other accredited
educational institutions (such as vocational and technical colleges) to
develop formal clinical training programs.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data to the program and to
enable HRSA to provide aggregate program data required by Congress
under the Government Performance and Results Act of 1993. These
measures cover the principal topic areas of interest to the Federal
Office of Rural Health Policy (FORHP), including: (a) Access to care;
(b) population demographics; (c) staffing; (d) consortium/network; (e)
sustainability; and (f) project specific domains. Several measures will
be used for this program. All measures will speak to FORHP's progress
toward meeting the goals.
Likely Respondents: The respondents are recipients of the Rural
Network Allied Health Training Program grant funding.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Rural Network Allied Health 10 1 10 6.55 65.5
Training Program Performance
Measures.......................
-------------------------------------------------------------------------------
Total....................... 10 .............. 10 .............. 65.5
----------------------------------------------------------------------------------------------------------------
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-11672 Filed 5-17-16; 8:45 am]
BILLING CODE 4165-15-P
