Proposed Collection; 60-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director), 72672-72673 [2020-25091]
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Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices
documenting electronic data files and
statistical analyses submitted to CVM to
support new animal drug applications.
These recommendations are intended to
reduce the number of revisions that may
be required for CVM to effectively
review data submissions. They are also
intended to simplify submission
preparation for sponsors by providing a
suggested documentation framework,
including a sample structure on how to
describe and organize the information
regarding the electronic data files and
statistical analysis programs.
This Level I guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Documenting
Electronic Data Files and Statistical
Analysis Programs.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this guidance refers to
previously approved collections of
information. These collections of
information are subject to review by
OMB under the PRA (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 514 have been approved
under OMB control number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidance-industry
or https://www.regulations.gov.
Dated: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25131 Filed 11–12–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1992]
Prospective Grant of an Exclusive
Patent License: Field-Deployable Mass
Spectrometer Diagnostic for SARS,
SARS–CoV–2 and Other Viruses,
Bacteria and Bacterial Serovar, and
Drug Impurities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is contemplating
the grant of an Exclusive Patent License
to practice the invention embodied in
the U.S. Patent listed in the
Supplementary Information section of
this notice to Advion, Inc. located in
Ithaca, New York.
DATES: Only written comments and/or
applications for a license which are
received by the Food and Drug
Administration’s Technology Transfer
Program on or before November 30,
2020 will be considered.
ADDRESSES: Inquiries and comments
relating to the contemplated Exclusive
Patent License should be directed to:
Ken Millburne, Food and Drug
Administration Technology Transfer
Program, Bldg. 1, Rm. 4213, Silver
Spring, MD 20993, 240–478–1662;
email: Kenneth.millburne@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
FDA Reference No.: E–2011–021:
‘‘Direct Impact Ionization (DII) Mass
Spectrometry.’’
I. U.S. Non-Provisional Application
13/271,182, filed October 11, 2011 (FDA
Reference No.: E–2011–021/US–02).
II. U.S. Patent granted April 22, 2014:
U.S. Patent 8,704,169 B2 (FDA
Reference No. E–2011–021/U.S.–02)
The patent rights in this invention
have been assigned to the Government
of the United States of America.
The prospective exclusive license
territory may be worldwide and in fields
of use that may be limited to
manufacture and commercialization of a
field-deployable mass spectrometer
diagnostic for the rapid detection of
SARS, SARS–CoV–2 and other viruses,
bacteria and bacterial serovar, and drug
impurities.
Above listed patent covers inventions
directed to a mass spectrometer for
analyzing samples suspected of having
microorganisms. It is also directed to
methods for generating a mass spectrum
profile of a sample.
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This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing. The prospective
exclusive license may be granted unless
within 15 days from the date of this
published notice, FDA 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.
In response to this notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this notice will be presumed
to contain business confidential
information and any release of
information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25142 Filed 11–12–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Special Volunteer and Guest
Researcher Assignment (Office of
Intramural Research, Office of the
Director)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
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
Office of Intramural Research (OIR),
Office of the Director (OD), 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.
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
SUMMARY:
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Federal Register / Vol. 85, No. 220 / Friday, November 13, 2020 / Notices
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Arlyn Garcia-Perez, Director
of Policy and Analysis, Office of
Intramural Research, Office of the
Director, National Institutes of Health, 1
Center Drive MSC 0140, Building 1,
Room 160, MSC–0140, Bethesda,
Maryland, 20892 or call non-toll-free
number (301) 496–1921 or (301) 496–
1381 or Email your request, including
your address to: GarciaA@od.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
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
SUPPLEMENTARY INFORMATION:
(OIR), Office of the Director (OD),
National Institutes of Health (NIH).
Need and Use of Information
Collection: Form Number: NIH–590 is a
single form completed by an NIH
official for each Guest Researcher or
Special Volunteer prior to his/her
arrival at NIH. The information on the
form is necessary for the approving
official to reach a decision on whether
to allow a Guest Researcher to use NIH
facilities, or whether to accept volunteer
services offered by a Special Volunteer.
If the original assignment is extended,
another form notating the extension is
completed to update the file. In
addition, each Special Volunteer and
Guest Researcher reads and signs an
NIH Agreement.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
422.
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: Special
Volunteer and Guest Researcher
Assignment form—EXTENSION OMB #
0925–0177, exp., date February 28,
2021, Office of Intramural Research
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
hour burden
hours
Type of respondents
Special Volunteer and Guest Researcher Assignment.
NIH Special Volunteer Agreement ....
NIH Guest Researcher Agreement ...
Special Volunteers and Guest researchers.
Special Volunteers ...........................
Guest Researchers ..........................
2,300
1
6/60
230
2,100
200
1
1
5/60
5/60
175
17
Totals .........................................
...........................................................
2,300
4,600
........................
422
Dated: November 4, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2020–25091 Filed 11–12–20; 8:45 am]
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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.
SUMMARY:
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Number of
respondents
Form name
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FOR FURTHER INFORMATION CONTACT:
Dianca Finch, Ph.D., 240–669–5503;
dianca.finch@nih.gov. Licensing
information and copies of the U.S.
patent application 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:
Identification of a New Human
Monoclonal Antibody That More
Potently Prevents Malaria Infection
Description of Technology:
Malaria is a major disease caused by
a parasite transmitted through the bite
of infected female mosquitoes. Globally,
an estimated 214 million cases of
malaria and 438,000 deaths from
malaria occur annually, with chidren in
African and South Asian regions being
most vulnerable. Approximately 1,500–
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2,000 cases of malaria are reported in
the United States each year, mostly in
returning travelers from malariaendemic countries. Among the
international travelers, military
personnel, diplomats, pregnant women,
children and older individuals with
weakened immune systems are more
likely to be at risk of malaria infection
and mortality.
Currently, there is no licensed vaccine
against Plasmodium falciparum, the
deadliest species of malaria parasites.
Antibodies can prevent malaria
infection by binding to sporozoites, the
infectious form of P. falciparum that is
transmitted to humans by the bites of
infected mosquitoes. The major target of
anti-sporozoite antibodies is the P.
falciparum circumsporozoite protein
(PfCSP), an abundant surface protein on
sporozoites that is essential for infecting
liver cells, which is the critical step for
initiating a productive infection. PfCSP
is comprised of an N-terminal domain,
a central region and the C-terminal
region.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
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[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Pages 72672-72673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25091]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Special Volunteer
and Guest Researcher Assignment (Office of Intramural Research, Office
of the Director)
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 Office of Intramural Research (OIR), Office of
the Director (OD), 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.
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
[[Page 72673]]
plans and instruments, submit comments in writing, or request more
information on the proposed project, contact: Dr. Arlyn Garcia-Perez,
Director of Policy and Analysis, Office of Intramural Research, Office
of the Director, National Institutes of Health, 1 Center Drive MSC
0140, Building 1, Room 160, MSC-0140, Bethesda, Maryland, 20892 or call
non-toll-free number (301) 496-1921 or (301) 496-1381 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: Special Volunteer and Guest Researcher
Assignment form--EXTENSION OMB # 0925-0177, exp., date February 28,
2021, Office of Intramural Research (OIR), Office of the Director (OD),
National Institutes of Health (NIH).
Need and Use of Information Collection: Form Number: NIH-590 is a
single form completed by an NIH official for each Guest Researcher or
Special Volunteer prior to his/her arrival at NIH. The information on
the form is necessary for the approving official to reach a decision on
whether to allow a Guest Researcher to use NIH facilities, or whether
to accept volunteer services offered by a Special Volunteer. If the
original assignment is extended, another form notating the extension is
completed to update the file. In addition, each Special Volunteer and
Guest Researcher reads and signs an NIH Agreement.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 422.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondents respondents responses per response (in hour burden
respondent hours) hours
----------------------------------------------------------------------------------------------------------------
Special Volunteer and Guest Special 2,300 1 6/60 230
Researcher Assignment. Volunteers and
Guest
researchers.
NIH Special Volunteer Special 2,100 1 5/60 175
Agreement. Volunteers.
NIH Guest Researcher Agreement Guest 200 1 5/60 17
Researchers.
---------------------------------------------------------------
Totals.................... ................ 2,300 4,600 .............. 422
----------------------------------------------------------------------------------------------------------------
Dated: November 4, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2020-25091 Filed 11-12-20; 8:45 am]
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