I-134 60 Day FRN

26900

Federal Register / Vol. 89, No. 74 / Tuesday, April 16, 2024 / Notices

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:
Dawn Taylor-Mulneix at 301–767–5189,
or [email protected].
Licensing information may be obtained
by communicating with 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copies of unpublished information
related to the invention.
SUPPLEMENTARY INFORMATION:
Technology description follows:
SUMMARY:

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Human Monoclonal Antibodies That
Target Plasmodium Falciparum
Sporozoites
Description of Technology
Malaria is one of the world’s deadliest
infectious diseases, causing an
estimated 249 million cases and 608,000
deaths annually, with children in the
regions of Africa and South Asia being
most vulnerable. Approx 2,000 cases of
malaria are reported in the United States
each year, by travelers from malaria-risk
countries. Malaria is a mosquito-borne
parasitic disease transmitted through
the bite of infected female mosquitoes,
which introduces Plasmodium
sporozoites into the bloodstream of the
human host. There are five Plasmodium
parasite species that cause malaria in
humans, of which, the vast majority of
life-threatening cases are caused by
infection with Plasmodium falciparum
parasites.
Researchers at NIAID have developed
11 human monoclonal antibodies that
bind to a unique site on the
circumsporozoite protein (CSP) on
Plasmodium falciparum sporozoites that
is not targeted by any known
monoclonal antibodies. These

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antibodies do not bind to recombinant
forms of CSP and as such bind to a
processed or post-translational form of
the protein processed by the
sporozoites. In vivo studies have shown
several of these antibodies can
substantially reduce liver parasite
burden in a mouse model of malaria.
These antibodies can work
cooperatively with known antibodies
that target the repeat region of CSP.
Some of these novel antibodies have
shown enhanced protection in an
animal model when combined with
known protective monoclonal
antibodies against sporozoites,
suggesting that together they may form
an effective cocktail to prevent malaria.
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
• Prophylactic and preventative
treatment against malaria.
Competitive Advantages
• These antibodies bind to a unique
site on the circumsporozoite protein
(CSP) on Plasmodium falciparum
sporozoites that is distinct from the
targets of pre-existing mAbs.
• These monoclonal antibodies can
be used alone or in combination with
existing antibodies.
Development Stage
• Pre-Clinical
Inventors: Joshua Tan, Ph.D.,
Cherrelle Dacon, Ph.D., both of NIAID.
Publications: n/a.
Intellectual Property: HHS Reference
No. E–212–2022–0. U.S. Provisional
Patent Application No. 63/409,016, filed
on September 22, 2022, and PCT Patent
Application No. PCT/US2023/074791,
filed on September 21, 2023.
Licensing Contact: To license this
technology, please contact Dawn TaylorMulneix at 301–767–5189, or
[email protected], and
reference E–212–2022.
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 this technology. Areas of
specific interest include (a) testing
developability of these antibodies (e.g.,
biophysical characteristics, crossreactivity, pharmacokinetics, toxicity),
(b) pre-clinical model assessment, and
(c) human clinical trials. For
collaboration opportunities, please

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contact Dawn Taylor-Mulneix at 301–
767–5189, or dawn.taylor-mulneix@
nih.gov.
Dated: April 8, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2024–08013 Filed 4–15–24; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0014]

Agency Information Collection
Activities; Revision of a Currently
Approved Collection: Declaration of
Financial Support
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 60-day notice.
AGENCY:

The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) invites
the general public and other Federal
agencies to comment upon this
proposed revision of a currently
approved collection of information. In
accordance with the Paperwork
Reduction Act (PRA) of 1995, the
information collection notice is
published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
burden (i.e. the time, effort, and
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until June
17, 2024.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0014 in the body of the letter, the
agency name and Docket ID USCIS–
2006–0072. Submit comments via the
Federal eRulemaking Portal website at
https://www.regulations.gov under eDocket ID number USCIS–2006–0072.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, telephone
number (240) 721–3000 (This is not a
toll-free number. Comments are not
accepted via telephone message). Please
note contact information provided here
is solely for questions regarding this
SUMMARY:

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Federal Register / Vol. 89, No. 74 / Tuesday, April 16, 2024 / Notices
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS website
at https://www.uscis.gov, or call the
USCIS Contact Center at 800–375–5283
(TTY 800–767–1833).
SUPPLEMENTARY INFORMATION:

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Comments
You may access the information
collection instrument with instructions
or additional information by visiting the
Federal eRulemaking Portal site at:
https://www.regulations.gov and
entering USCIS–2006–0072 in the
search box. Comments must be
submitted in English, or an English
translation must be provided. All
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to consider
limiting the amount of personal
information that you provide in any
voluntary submission you make to DHS.
DHS may withhold information
provided in comments from public
viewing that it determines may impact
the privacy of an individual or is
offensive. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
Written comments and suggestions
from the public and affected agencies
should address one or more of the
following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.

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Overview of This Information
Collection
(1) Type of Information Collection:
Revision of a Currently Approved
Collection.
(2) Title of the Form/Collection:
Declaration of Financial Support.
(3) Agency form number, if any, and
the applicable component of the DHS
sponsoring the collection: I–134; USCIS.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. DHS and consular officers
of the Department of State (DOS) use
Form I–134 to determine whether, at the
time of the beneficiary’s application,
petition, or request for certain
immigration benefits, that beneficiary
has sufficient financial support to pay
for expenses for the duration of their
temporary stay in the United States.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: The estimated total number of
respondents for the information
collection I–134 is 2,500 and the
estimated hour burden per response is
1.65 hours.
(6) An estimate of the total public
burden (in hours) associated with the
collection: The total estimated annual
hour burden associated with this
collection is 4,125 hours.
(7) An estimate of the total public
burden (in cost) associated with the
collection: The estimated total annual
cost burden associated with this
collection of information is $10,625.
Dated: April 8, 2024.
Samantha L Deshommes,
Chief, Regulatory Coordination Division,
Office of Policy and Strategy, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2024–08014 Filed 4–15–24; 8:45 am]
BILLING CODE 9111–97–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0122]

Agency Information Collection
Activities; Revision of a Currently
Approved Collection: USCIS Online
Account Access
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 30-Day notice.
AGENCY:

The Department of Homeland
Security (DHS), U.S. Citizenship and

SUMMARY:

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26901

Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The purpose of this notice is to
allow an additional 30 days for public
comments.
DATES: Comments are encouraged and
will be accepted until May 16, 2024.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, must be
submitted via the Federal eRulemaking
Portal website at http://
www.regulations.gov under e-Docket ID
number USCIS–2011–0015. All
submissions received must include the
OMB Control Number 1615–0122 in the
body of the letter, the agency name and
Docket ID USCIS–2011–0015.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, telephone
number (240) 721–3000 (This is not a
toll-free number; comments are not
accepted via telephone message.). Please
note contact information provided here
is solely for questions regarding this
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS website
at http://www.uscis.gov, or call the
USCIS Contact Center at 800–375–5283
(TTY 800–767–1833).
SUPPLEMENTARY INFORMATION:
Comments
The information collection notice was
previously published in the Federal
Register on August 14, 2023, at 88 FR
55065, allowing for a 60-day public
comment period. USCIS did receive two
comments in connection with the 60day notice.
You may access the information
collection instrument with instructions,
or additional information by visiting the
Federal eRulemaking Portal site at:
http://www.regulations.gov and enter
USCIS–2011–0015 in the search box.
Comments must be submitted in
English, or an English translation must
be provided. The comments submitted
to USCIS via this method are visible to
the Office of Management and Budget
and comply with the requirements of 5
CFR 1320.12(c). All submissions will be
posted, without change, to the Federal
eRulemaking Portal at http://
www.regulations.gov, and will include
any personal information you provide.

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