Proposed Collection; 60-Day Comment Request; Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute), 53885-53886 [2018-23313]
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53885
Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NINDS Diversity Training
Grant Application Review.
Date: November 16, 2018.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6001
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: William C. Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3204,
MSC 9529, Bethesda, MD 20892–9529, (301)
496–0660, benzingw@mail.nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Blueprint Neurotherapeutics
Review Meeting.
Date: November 28, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Georgetown Suites, 1111 30th Street
NW, Washington, DC 20007.
Contact Person: Joel A. Saydoff, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3205,
MSC 9529, Bethesda, MD 20892–9529, (301)
496–9223, joel.saydoff@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: October 18, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–23264 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Investigational Agent
Accountability Record Forms in the
Conduct of Investigational Trials for
the Treatment of Cancer (National
Cancer Institute)
AGENCY:
National Institutes of Health,
daltland on DSKBBV9HB2PROD with NOTICES
HHS.
ACTION:
Proposed Collection Title:
Investigational Agent Accountability
Record Forms in the Conduct of
Investigational Trials for the Treatment
of Cancer, 0925–0613, Expiration Date
3/31/2019, Revision, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The U.S. Food and Drug
Administration (FDA) holds the
National Cancer Institute (NCI), Division
of Cancer Treatment and Diagnosis/
Cancer Therapy Evaluation Program
(NCI/DCTD/CTEP) and the Division of
Cancer Prevention (DCP) responsible, as
a sponsor of investigational drug trials,
to assure the FDA that systems for
accountability are being maintained by
investigators in its clinical trials
program. Data obtained from the
Investigational Agent Accountability
Record Forms (aka. Drug Accountability
Record Forms—DARF) are used to track
the dispensing of investigational
anticancer agents from receipt from the
NCI to dispensing or administration to
patients. Requirements for the tracking
of investigational agents under an
Investigational New Drug Application
are outlined in Title 21 Code of Federal
Regulations (CRF) part 312. NCI and/or
its auditors use this information to
ensure compliance with federal
regulations and NCI policies.
Previously, the investigator registration
forms and process were part of this
submission. These forms were more
appropriately submitted and approved
under the CTEP Branch and Support
Contracts Forms and Surveys in July
2018 (OMB No. 0925–0753; Expiration
Date 7/31/2021). Thus, the investigator
registration forms are no longer
included in this request.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden are 3,033
hours.
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Charles Hall, Chief,
Pharmaceutical Management Branch,
Cancer Therapy Evaluation Program,
Division of Cancer Diagnosis and
Treatment, National Cancer Institute,
9609 Medical Center Drive, Bethesda,
Maryland, 20892 or call non-toll-free
number (240) 276–6575 or Email your
request, including your address to:
HallCh@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address 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 minimizes
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.
FOR FURTHER INFORMATION CONTACT:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Category of respondent
Individuals (DARF) ...........................................................................................
VerDate Sep<11>2014
18:10 Oct 24, 2018
Jkt 247001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
2,133
E:\FR\FM\25OCN1.SGM
16
25OCN1
Average time
per response
(in hours)
4/60
Total annual
burden hours
2,275
53886
Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Category of respondent
Average time
per response
(in hours)
Total annual
burden hours
Individuals (DARF-Oral) ...................................................................................
711
16
4/60
758
Total ..........................................................................................................
2,844
45,504
........................
3,033
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2018–23313 Filed 10–24–18; 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 invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing 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:
Peter Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
Recombinant Respiratory Syncytial
Virus Challenge Strain
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
Description of Technology
RSV is the most important viral agent
of severe respiratory tract disease
worldwide, especially in infants and
young children, and it also causes
severe disease in the elderly and in
immunocompromised individuals.
There are no licensed vaccines or
antivirals suitable for routine use.
VerDate Sep<11>2014
18:10 Oct 24, 2018
Jkt 247001
This invention relates to a reverse
genetics system and cDNA-derived virus
for a contemporary wild-type clinical
isolate of RSV of antigenic subgroup A,
termed RSV strain A/Maryland/001/11,
that was isolated in 2011 from an adult
with respiratory illness. The genomic
sequence was determined. A reverse
genetics system was created encoding a
recombinant, replication competent
RSV that contains a codon-optimized G
ORF, which was done to stabilize the
cDNA for replication in bacteria.
Because this virus was generated by
reverse genetics, it is a ‘‘clean’’ virus
with a well-defined passage history.
Clinical study material of this challenge
virus has been manufactured and is
available for use as an U.S. Food and
Drug Administration (FDA) regulated
Investigational New Drug (IND) in
clinical studies in adult volunteers
within and outside of the United States.
Preliminary clinical data confirmed that
this virus efficiently infects and
replicates in 95% of study participants
pre-selected for pre-existing RSV
antibody titers in the bottom 50% of the
range. The challenge virus causes mild
upper respiratory illness in the majority
of infected participants, typical for RSV
illness in otherwise healthy adults. This
provides a suitable challenge system for
evaluating antivirals, as well as vaccines
for older children and adults. This also
could be used for developing liveattenuated RSV vaccine candidates
based on this contemporary strain, using
the stabilized point mutations,
stabilized codon-deletions, and genedeletions that were previously used in
RSV strain A2.
This invention relates to a reverse
genetics system and the encoded RSV
vaccine challenge strain that infects and
causes disease in RSV-experienced
adults and is available for antiviral and
vaccine research.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications
PO 00000
• Vaccine development
• Viral diagnostics
Frm 00040
Fmt 4703
Sfmt 4703
• Vaccine research
Competitive Advantages
• Ease of manufacture
• Clinical trial material
• Low-cost vaccines
• Intranasal administration/needlefree delivery
Development Stage
• In vivo data assessment (human)
Inventors: Ursula Buchholz (NIAID),
Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–235–2018–0.
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; peter.soukas@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize for development of a
vaccine for respiratory or other
infections. For collaboration
opportunities, please contact Peter
Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov.
Dated: October 12, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–23311 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53885-53886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Investigational
Agent Accountability Record Forms in the Conduct of Investigational
Trials for the Treatment of Cancer (National Cancer Institute)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Cancer Institute (NCI) will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Charles
Hall, Chief, Pharmaceutical Management Branch, Cancer Therapy
Evaluation Program, Division of Cancer Diagnosis and Treatment,
National Cancer Institute, 9609 Medical Center Drive, Bethesda,
Maryland, 20892 or call non-toll-free number (240) 276-6575 or Email
your request, including your address to: [email protected]. Formal
requests for additional plans and instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address 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 minimizes 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.
Proposed Collection Title: Investigational Agent Accountability
Record Forms in the Conduct of Investigational Trials for the Treatment
of Cancer, 0925-0613, Expiration Date 3/31/2019, Revision, National
Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The U.S. Food and Drug
Administration (FDA) holds the National Cancer Institute (NCI),
Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation
Program (NCI/DCTD/CTEP) and the Division of Cancer Prevention (DCP)
responsible, as a sponsor of investigational drug trials, to assure the
FDA that systems for accountability are being maintained by
investigators in its clinical trials program. Data obtained from the
Investigational Agent Accountability Record Forms (aka. Drug
Accountability Record Forms--DARF) are used to track the dispensing of
investigational anticancer agents from receipt from the NCI to
dispensing or administration to patients. Requirements for the tracking
of investigational agents under an Investigational New Drug Application
are outlined in Title 21 Code of Federal Regulations (CRF) part 312.
NCI and/or its auditors use this information to ensure compliance with
federal regulations and NCI policies. Previously, the investigator
registration forms and process were part of this submission. These
forms were more appropriately submitted and approved under the CTEP
Branch and Support Contracts Forms and Surveys in July 2018 (OMB No.
0925-0753; Expiration Date 7/31/2021). Thus, the investigator
registration forms are no longer included in this request.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden are 3,033 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Category of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Individuals (DARF).............................. 2,133 16 4/60 2,275
[[Page 53886]]
Individuals (DARF-Oral)......................... 711 16 4/60 758
---------------------------------------------------------------
Total....................................... 2,844 45,504 .............. 3,033
----------------------------------------------------------------------------------------------------------------
Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2018-23313 Filed 10-24-18; 8:45 am]
BILLING CODE 4140-01-P
