Proposed Collection; 60-Day Comment Request; Process Assessment Review of the Division of Acquired Immunodeficiency Syndrome (DAIDS) Critical Events Policy Implementation (CEPI) Program (NIAID), 19633-19634 [2014-07960]
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19633
Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices
receive due consideration, the
prospective trainee is encouraged to
complete all relevant fields. The
information is for internal use to make
decisions about prospective fellows and
students that could benefit from the
DCEG program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
175.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Number of
respondents
Summer Students ....................................................................
Full-time Fellows ......................................................................
Dated: April 3, 2014.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–07957 Filed 4–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
TKELLEY on DSK3SPTVN1PROD with NOTICES
Proposed Collection; 60-Day Comment
Request; Process Assessment Review
of the Division of Acquired
Immunodeficiency Syndrome (DAIDS)
Critical Events Policy Implementation
(CEPI) Program (NIAID)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
VerDate Mar<15>2010
17:54 Apr 08, 2014
Jkt 232001
Number of
responses
per respondent
300
150
1
1
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Lyndi Lahl, RN, MS,
Office for Policy in Clinical Research
Operations, DAIDS, NIAID, 6700B
Rockledge Drive, Room 4254, Bethesda,
MD 20852, or call non-toll-free number
301–435–3756, or Email your request,
including your address to: Lynda.Lahl@
nih.gov. Formal requests for additional
plans and instruments must be
requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Process
Assessment Review of the Division of
Acquired Immunodeficiency Syndrome
(DAIDS) Critical Events Policy
Implementation (CEPI) Program, 0925New, National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This is a new data collection
to assess the CEPI program’s progression
to fulfillment of its program goals and
will assess whether the CEPI program is
implemented and functioning as
intended. The program goals for CEPI
are: (1) Awareness & Accessibility—The
target populations (DAIDS Staff,
extramural researchers, external
stakeholders) are aware of the DAIDS
Critical Events (CE) policy and manual
and associated documents and whether
the policy and associated documents are
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Average burden
per response
(in hours)
20/60
30/60
Total annual
burden hours
100
75
readily accessible.; (2)
Understandability—The Critical Events
policy and manual clearly articulate
DAIDS expectations for CE policy
implementation by the target
populations. The CE policy and manual
should establish a common base of
understanding and promote positive
attitudes towards event reporting; and
(3) Applicability—Target populations
are able to correctly identify which
Critical Events have occurred at their
sites and are able to apply the CE policy
and manual to their events.
Findings will provide data to inform
DAIDS and Protection of Participants,
Evaluation and Policy (ProPEP)
leadership regarding further policy
deployment decisions. Information
collected will be used to determine how
effectively the CEPI Program meets
extramural researchers’ needs. By
assessing the CEPI Program, DAIDS will
determine how successfully it is
reaching its goals—to facilitate and
improve the quality of clinical research
conducted within the division. In
addition, the CEPI Program assessment
will determine whether previously
recommended improvements included
in the DPIP assessment were
successfully incorporated into the
policy rollout process. The results may
be used as a model for policy
development to facilitate compliance in
reporting certain incidents and
implementation in other National
Institutes of Health (NIH) Institutes and
Centers (ICs) and will be shared with all
interested divisions and institutes
within the NIH. There are no plans to
share this information with the public.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
386.
E:\FR\FM\09APN1.SGM
09APN1
19634
Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Data collection
DAIDS Staff, ER/ES ..........................
Survey ..............................................
Focus Group-IC Review ...................
Focus Group ....................................
Dated: April 3, 2014.
Brandie Taylor,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2014–07960 Filed 4–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Monoclonal Antibody Fragments for
Targeting Therapeutics to Growth Plate
Cartilage
Description of Technology: A child’s
growth is dependent on the proper
functioning of the growth plate, a
specialized cartilage structure located at
the ends of long bones and within the
vertebrae. The primary function of the
growth plate is to generate new
cartilage, which is then converted into
bone tissue and results in the
lengthening of bones. Current
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500
81
81
treatments for severe short stature and
skeletal growth disorders are limited.
Recombinant human growth hormone
(GH) is typically used but the results are
less than optimal and have potential
adverse effects. The instant invention
discloses that monoclonal antibodies
that bind to matrilin-3, a protein
specifically expressed in cartilage
tissue, could be used for treating or
inhibiting growth plate disorders, such
as a skeletal dysplasia or short stature.
Potential Commercial Applications: A
new treatment option for growth plate
disorders, such as skeletal dysplasia or
short stature.
Competitive Advantages: Avoidance
of the risks associated with systemic
treatment using growth hormone, such
as increased intracranial pressure,
slipped capital femoral epiphysis,
insulin resistance, and possibly type II
diabetes.
Development Stage:
• Early-stage.
• In vitro data available.
Inventors: Jeffrey Baron (NICHD), Sao
Fong (Crystal) Cheung (NICHD), Chun
Kin Julian Lui (NICHD), Dimiter S.
Dimitrov (NCI), Zhongyu Zhu (NCI).
Intellectual Property: HHS Reference
No. E–003–2014/0—US Application No.
61/927,904 filed 15 Jan 2014.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565; tongb@
mail.nih.gov.
Collaborative Research Opportunity:
The Eunice Kennedy Shriver National
Institute of Child Health and Human
Development and the National Cancer
Institute are seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize treatment of skeletal
disorders and short stature to increase
growth using targeting antibodies. For
collaboration opportunities, please
contact Joseph Conrad III, Ph.D. at
jmconrad@mail.nih.gov.
Human Antibodies Against Middle East
Respiratory Syndrome Coronavirus
Description of Technology: No
effective therapeutics or vaccines are
available against Middle East
Respiratory Syndrome Coronavirus
(MERS-CoV). This technology is for
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
Average time
per response
1
1
1
30/60
10/60
90/60
Total
annual burden
hours
250
14
122
human antibodies targeting MERS-CoV.
Certain of these antibodies bind with
epitopes of the MERS-CoV receptor
binding domain (RBD) of MERS-CoV
spike (S) protein with high affinity and
are capable of neutralized the virus in
a pseudovirus assay. The MERS-CoV–S
protein is believed to be required for
binding and virus entry during MERSCoV infection. The human to human
aspect of transmission and the high
mortality rate associated with MERSCoV infection have raised concerns over
the potential for a future MERS-CoV
pandemic and emphasized the need for
development of effective therapeutics
and vaccines. The antibodies of this
technology represent candidate
antibody-based therapeutics for
treatment of MERS-CoV infection.
Potential Commercial Applications:
Antibody-based therapeutics for
treatment of MERS-CoV infection.
Competitive Advantages:
• No vaccine or other biologic
therapy is available.
• High binding (sub-nanomolar)
affinity.
• Relative safety and long half-lives.
Development Stage:
• Early-stage.
• In vitro data available.
Inventors: Dimiter Dimitrov (NCI),
Tianlei Ying (NCI), Tina Yu (NCI), Kwok
Yuen (University of Hong Kong).
Publications:
1. Zaki AM, et al. Isolation of a novel
coronavirus from a man with
pneumonia in Saudi Arabia. N Engl
J Med. 2012 Nov 8;367(19):1814–20.
[PMID 23075143]
2. Zhu Z, et al. Exceptionally potent
cross-reactive neutralization of
Nipah and Hendra viruses by a
human monoclonal antibody. J
Infect Dis. 2008 Mar 15;197(6):846–
53. [PMID 18271743]
3. Zhu Z, et al. Potent cross-reactive
neutralization of SARS coronavirus
isolates by human monoclonal
antibodies. Proc Natl Acad Sci U S
A. 2007 Jul 17;104(29):12123–8.
[PMID 17620608]
Intellectual Property: HHS Reference
No. E–002–2014/0—U.S. Patent
Application No. 61/892,750 filed 18 Oct
2013.
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19633-19634]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07960]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Process Assessment
Review of the Division of Acquired Immunodeficiency Syndrome (DAIDS)
Critical Events Policy Implementation (CEPI) Program (NIAID)
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity
for public comment on proposed data collection projects, the National
Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), will publish periodic summaries of proposed
projects to be submitted to the Office of Management and Budget (OMB)
for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Lyndi
Lahl, RN, MS, Office for Policy in Clinical Research Operations, DAIDS,
NIAID, 6700B Rockledge Drive, Room 4254, Bethesda, MD 20852, or call
non-toll-free number 301-435-3756, or Email your request, including
your address to: Lynda.Lahl@nih.gov. Formal requests for additional
plans and instruments must be requested in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Process Assessment Review of the Division of
Acquired Immunodeficiency Syndrome (DAIDS) Critical Events Policy
Implementation (CEPI) Program, 0925-New, National Institute of Allergy
and Infectious Diseases (NIAID), National Institutes of Health (NIH).
Need and Use of Information Collection: This is a new data
collection to assess the CEPI program's progression to fulfillment of
its program goals and will assess whether the CEPI program is
implemented and functioning as intended. The program goals for CEPI
are: (1) Awareness & Accessibility--The target populations (DAIDS
Staff, extramural researchers, external stakeholders) are aware of the
DAIDS Critical Events (CE) policy and manual and associated documents
and whether the policy and associated documents are readily
accessible.; (2) Understandability--The Critical Events policy and
manual clearly articulate DAIDS expectations for CE policy
implementation by the target populations. The CE policy and manual
should establish a common base of understanding and promote positive
attitudes towards event reporting; and (3) Applicability--Target
populations are able to correctly identify which Critical Events have
occurred at their sites and are able to apply the CE policy and manual
to their events.
Findings will provide data to inform DAIDS and Protection of
Participants, Evaluation and Policy (ProPEP) leadership regarding
further policy deployment decisions. Information collected will be used
to determine how effectively the CEPI Program meets extramural
researchers' needs. By assessing the CEPI Program, DAIDS will determine
how successfully it is reaching its goals--to facilitate and improve
the quality of clinical research conducted within the division. In
addition, the CEPI Program assessment will determine whether previously
recommended improvements included in the DPIP assessment were
successfully incorporated into the policy rollout process. The results
may be used as a model for policy development to facilitate compliance
in reporting certain incidents and implementation in other National
Institutes of Health (NIH) Institutes and Centers (ICs) and will be
shared with all interested divisions and institutes within the NIH.
There are no plans to share this information with the public.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 386.
[[Page 19634]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondents Data collection Number of responses per Average time Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
DAIDS Staff, ER/ES............ Survey.......... 500 1 30/60 250
Focus Group-IC 81 1 10/60 14
Review.
Focus Group..... 81 1 90/60 122
----------------------------------------------------------------------------------------------------------------
Dated: April 3, 2014.
Brandie Taylor,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2014-07960 Filed 4-8-14; 8:45 am]
BILLING CODE 4140-01-P
