Published 30 Day Federal Register Notice (FRN)

Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Improved Live-Attenuated
Vaccine for Respiratory Syncytial Virus
National Institutes of Health.
Notice.

AGENCY:
ACTION:

The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Commercialization
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the Summary
Information section of this notice to
Codagenix, Inc. (Codagenix), having a
place of business in Farmingdale, New
York, U.S.A.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Allergy and Infectious Diseases’
Technology Transfer and Intellectual
Property Office on or before August 18,
2021 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Commercialization Patent
License should be directed to: Peter
Soukas, Technology Transfer and Patent
Specialist, Technology Transfer and
Intellectual Property Office, National
Institute of Allergy and Infectious
Diseases, National Institutes of Health;
Email: [email protected]; Telephone:
(301) 496–2644; Facsimile: (240) 627–
3117.
SUPPLEMENTARY INFORMATION:

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SUMMARY:

Intellectual Property
U.S. Provisional Patent Application
Number 63/023,949, filed May 13, 2020
and PCT Patent Application Number
PCT/US2021/32305, filed May 13, 2021,
entitled ‘‘Improved Live-Attenuated
Vaccine for Respiratory Syncytial Virus
(RSV) Bearing Codon-Pair Deoptimized
NS1, NS2, N, P, M and SH Genes and
Additional Point Mutations in the P
Gene,’’ [HHS Reference No. E–104–
2020–0]; and U.S. and foreign patent
applications claiming priority to the
aforementioned applications.
The patent rights in this invention
have been assigned to the Government
of the United States of America.
The prospective exclusive licensed
territory may be worldwide, and the
field of use may be limited to: ‘‘Liveattenuated codon-deoptimized human
respiratory syncytial virus vaccine.’’

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RSV is the most important viral agent
of severe respiratory disease in infants
and young children worldwide and also
causes substantial morbidity and
mortality in older adults. RSV is
estimated to cause more than 33 million
lower respiratory tract illnesses, three
million hospitalizations, and nearly
200,000 childhood deaths worldwide
annually, with many deaths occurring
in developing countries. However,
despite the prevalence of RSV and the
dangers associated with infection, no
RSV vaccine has been successfully
developed to date. Accordingly, there is
a public health need for RSV vaccines.
This vaccine candidate comprises live
RSV that was attenuated by subjecting
the protein-coding sequences of the
viral NS1, NS2, N, P, M, and SH genes
to codon-pair deoptimization, which
resulted in many nucleotide
substitutions that were silent at the
amino acid level but conferred
attenuation. In addition, specific amino
acid substitutions were identified and
introduced into the P protein that
improved attenuation and genetic
stability. Genetic stability was
confirmed in vitro, and attenuation was
confirmed in experimental animals.
This live-attenuated RSV vaccine is
designed to be administered intranasally
by drops or spray to infants and young
children. Based on experience with
other live-attenuated RSV vaccine
candidates, the present candidates are
anticipated to be well tolerated in
humans and are available for clinical
evaluation. The National Institute of
Allergy and Infectious Diseases has
extensive experience and capability in
evaluating live-attenuated RSV vaccine
candidates in pediatric clinical studies.
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, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Institute of Allergy and Infectious
Diseases 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
commercialization license. 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

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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.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–16462 Filed 8–2–21; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2021–0016; OMB No.
1660–0086]

Agency Information Collection
Activities: Proposed Collection;
Comment Request; National Flood
Insurance Program—Mortgage
Portfolio Protection Program (MPPP);
Ask the Advocate Web Form
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: 30-Day notice of revision and
request for comments.
AGENCY:

The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public to take this
opportunity to comment on a revision of
a previously approved information
collection for which approval has
expired. FEMA will submit the
information collection abstracted below
to the Office of Management and Budget
for review and clearance in accordance
with the Paperwork Reduction Act of
1995, this notice seeks comments
concerning an amendment to a
currently-approved collection of
information related to the National
Flood Insurance Program (NFIP),
Mortgage Portfolio Protection Program
(MPPP), which is an option that
companies participating in the National
Flood Insurance Program can use to
bring their mortgage loan portfolios into
compliance with the flood insurance
purchase requirements. This amended
notice seeks comments concerning the
collection of information related to the
Office of the Flood Insurance Advocate
(OFIA).
DATES: Comments must be submitted on
or before September 2, 2021.
SUMMARY:

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Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices

Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
For information related to the NFIP
Mortgage Portfolio Protection Program
(MPPP), contact Kelly Bronowicz,
Industry Management Branch Chief,
FIMA, FEMA, at 202–557–9488, or
[email protected].
For information related to the Ask the
Advocate web form, contact Joe Cecil,
Advocate Representative Team Lead,
Office of the Flood Insurance Advocate,
FIMA, FEMA, at 202–701–3465, or
[email protected].
Requests for additional information or
copies of the information collection
should be made to the Forms &
Information Collections Manager,
Information Management Division, 500
C Street SW, Washington, DC 20472,
email address [email protected].
SUPPLEMENTARY INFORMATION: Pertaining
to the MPPP, federal lenders and
Federally-regulated or sponsored
lending institutions may not make,
increase, extend, or renew any loan
secured by improved real property
located in a special flood hazard area
(SFHA) unless the building and any
personal property securing the loan is
covered by flood insurance for the life
of the loan. See Flood Disaster
Protection Act of 1973 (FDPA) § 102
(Pub. L. 93–234; 42 U.S.C. 4012a). The
FEMA Administrator carries out the
NFIP to enable interested persons to
purchase insurance against loss
resulting from physical damage to or
loss of real or personal property arising
from flood in the United States. See
National Flood Insurance Act of 1968
(NFIA) (Pub. L. 90–448, title XIII; 42
U.S.C. 4001 et seq.).
In general, individual mortgagees
subject to the requirements of the FDPA
obtain and maintain flood insurance for
their individual properties. When
individual mortgagees to not obtain
required flood insurance, the NFIP’s
Mortgage Portfolio Protection program
(MPPP) allows covered lenders to
ensure compliance with the
requirements of FDPA by selling making
available special coverage for the
lender’s entire mortgage portfolio. See
44 CFR 62.23(l). In order sell MPPP
policies, private insurance companies
participating in the NFIP’s Write Your

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ADDRESSES:

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Own (WYO) Program must apply for
and annually renew their election to
voluntarily participate in the MPPP.
This proposed information collection
previously published in the Federal
Register on May 25, 2021, at 86 FR
28122 with a 60-day public comment
period. No comments were received.
This information collection expires on
December 31, 2021. FEMA is requesting
a revision of this currently approved
collection. The purpose of this notice is
to notify the public that FEMA will
submit the information collection
abstracted below to the Office of
Management and Budget for review and
clearance.
Pertaining to the Ask the Advocate
Web Form, Section 24 of the
Homeowner Flood Insurance
Affordability Act of 2014 (42 U.S.C.
4033), Public Law 113–89, 128 Stat.
1030, requires FEMA to designate a
Flood Insurance Advocate that would
advocate for the fair treatment of NFIP
policyholders and property owners by:
(1) Providing education and guidance
on all aspects of the NFIP, (2)
identifying trends affecting the public,
and (3) making recommendations for
NFIP program improvements to FEMA
leadership. Pursuant to this authority,
FEMA established the Office of the
Flood Insurance Advocate (OFIA) on
December 22, 2014.
Members of the public regularly
contact OFIA seeking assistance on the
NFIP. OFIA seeks to facilitate the timely
and effective management of these
inquiries by creating a web form on
OFIA’s web page at https://
www.fema.gov/flood-insurance/
advocate. The web form will allow users
to provide information that includes all
the data necessary for OFIA to perform
its Congressionally-mandated duties
and responsibilities.
Consumers who submit an inquiry to
OFIA will be required to fill-out ten (10)
informational fields on the Ask the
Advocate web form. These fields
include: (1) First name, (2) Last name,
(3) Email address, (4) Confirm email
address, (5) How did you hear of
Advocate’s office (pull-down list), (6)
Contact role (list field), (7) State (pulldown list), (8) ZIP code, (9) Subject (of
inquiry) and (10) Questions/Comment
(regarding inquiry). An eleventh (11th)
field is a security CAPTCHA field
intended to distinguish human from
machine input as a way of thwarting
spam and automated extraction of data
from websites.
When a consumer submits this
information, the data will be collected
and stored on OFIA’s Department of
Homeland Security/FEMA-approved
Customer Relationship Management

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cloud-based environment hosted by
Salesforce.
Once OFIA receives this information,
the inquiry will be assigned a systemgenerated ‘‘Case number’’, and then the
case is then assigned to an OFIA
Advocate Representative (FEMA
employee). Using the data collected
from the Ask the Advocate web form,
the Advocate Representative will
research the customer’s inquiry and
offer education and guidance to help the
customer navigate the NFIP process.
Collection of Information
Title: National Flood Insurance
Program—Mortgage Portfolio Protection
Program (MPPP).
Type of Information Collection:
Revision of a currently approved
information collection.
OMB Number: 1660–0086.
FEMA Forms: Ask the Advocate Web
Form (form number pending OMB
approval).
Abstract: Regarding the MPPP, FEMA
needs the information to ensure that
private insurance companies that join
the NFIP’s WYO Program meet all state
and federal requirements for insurance
companies. Requirements include a
good business record and satisfactory
rating in their field. There is no other
way to obtain this information because
it is specific to each company that
applies to join the NFIP.
Regarding the Ask the Advocate Web
Form, the Homeowner Flood Insurance
Affordability Act of 2014 requires
FEMA to designate a Flood Insurance
Advocate that would advocate for the
fair treatment of NFIP policyholders and
property owners. Pursuant to this
authority, FEMA established OFIA on
December 22, 2014.
Members of the public regularly
contact OFIA seeking assistance on the
NFIP. OFIA seeks to facilitate the timely
and effective management of these
inquiries through a web form on OFIA’s
web page. The web form will allow
users to provide information that
includes all the data necessary for OFIA
to fulfill its duties and responsibilities.
Affected Public: Individuals,
households, businesses, or other forprofit.
Estimated Number of Respondents:
1,041.
Estimated Number of Responses:
1,041.
Estimated Total Annual Burden
Hours: 227.
Estimated Total Annual Respondent
Cost: $11,856.
Estimated Respondents’ Operation
and Maintenance Costs: $0.00.
Estimated Respondents’ Capital and
Start-Up Costs: $0.00.

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Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices
Estimated Total Annual Cost to the
Federal Government: $71,930.
Comments
Comments may be submitted as
indicated in the ADDRESSES caption
above. Comments are solicited to (a)
evaluate whether the proposed data
collection is necessary for the proper
performance of the agency, including
whether the information shall have
practical utility; (b) 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;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) 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.
Millicent L. Brown,
Senior Manager, Records Management
Branch, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. 2021–16507 Filed 8–2–21; 8:45 am]
BILLING CODE 9111–52–P

DEPARTMENT OF HOMELAND
SECURITY
[DHS Docket No. ICEB–2021–0008]
RIN 1653–ZA20

Employment Authorization for Haitian
F–1 Nonimmigrant Students
Experiencing Severe Economic
Hardship as a Direct Result of the
Current Crisis in Haiti
U.S. Immigration and Customs
Enforcement (ICE), DHS.
ACTION: Notice.
AGENCY:

This notice announces that
the Secretary of Homeland Security
(Secretary) has suspended certain
regulatory requirements for F–1
nonimmigrant students whose country
of citizenship is Haiti (regardless of
country of birth) and who are
experiencing severe economic hardship
as a direct result of the current crisis in
Haiti. The Secretary is taking action to
provide relief to Haitian citizens who
are lawful F–1 nonimmigrant students
so the students may request
employment authorization, work an
increased number of hours while school
is in session, and reduce their course

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SUMMARY:

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load while continuing to maintain F–1
nonimmigrant student status. DHS will
deem an F–1 nonimmigrant student
who receives employment authorization
by means of this notice to be engaged in
a ‘‘full course of study’’ for the duration
of the employment authorization, if the
nonimmigrant student satisfies the
minimum course load requirement
described in this notice.
DATES: This F–1 notice is effective
August 3, 2021 through February 3,
2023.
FOR FURTHER INFORMATION CONTACT:
Sharon Snyder, Unit Chief, Policy and
Response Unit, Student and Exchange
Visitor Program, MS 5600, U.S.
Immigration and Customs Enforcement,
500 12th Street SW, Washington, DC
20536–5600; email: [email protected],
telephone: (703) 603–3400. This is not
a toll-free number. Program information
can be found at http://www.ice.gov/
sevis/.
SUPPLEMENTARY INFORMATION:
What action is the Department of
Homeland Security (DHS) taking under
this notice?
The Secretary of Homeland Security
is exercising authority under 8 CFR
214.2(f)(9) to temporarily suspend the
applicability of certain requirements
governing on-campus and off-campus
employment for F–1 nonimmigrant
students whose country of citizenship is
Haiti (regardless of country of birth)
who are present in the United States in
lawful F–1 nonimmigrant student status
as of August 3, 2021, and who are
experiencing severe economic hardship
as a direct result of the current crisis in
Haiti. DHS initially suspended certain
regulatory requirements for F–1
nonimmigrant students experiencing
severe economic hardship as a direct
result of the January 12, 2010
earthquake in Haiti. See 75 FR 56120
(Sep. 15, 2010). The original notice was
effective from September 15, 2010, until
July 22, 2011. A subsequent notice
provided for an 18-month extension
from July 22, 2011, through January 22,
2013. See 76 FR 28997 (May 19, 2011).
A third notice provided another 18month extension from January 22, 2013,
through July 22, 2014. See 77 FR 59942
(Oct. 1, 2012). A fourth notice provided
for another 18-month extension from
July 22, 2014, through January 22, 2016.
See 79 FR 11805 (Mar. 3, 2014). A fifth
notice provided for another 18-month
extension from January 22, 2016,
through July 22, 2017. See 80 FR 51579
(Aug. 25, 2015). Effective with this
publication, suspension of the
employment limitations is available
through February 3, 2023, for those who

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are in lawful F–1 nonimmigrant status
as of August 3, 2021. DHS will deem an
F–1 nonimmigrant student granted
employment authorization through this
notice to be engaged in a ‘‘full course of
study,’’ for the duration of the
employment authorization if the student
satisfies the minimum course load set
forth in this notice.1 See 8 CFR
214.2(f)(6)(i)(F).
Who is covered by this notice?
This notice applies exclusively to F–
1 nonimmigrant students who meet all
of the following conditions:
(1) Are citizens of Haiti, regardless of
country of birth;
(2) Were lawfully present in the
United States in an F–1 nonimmigrant
status on August 3, 2021, under section
101(a)(15)(F)(i) of the Immigration and
Nationality Act (INA), 8 U.S.C.
1101(a)(15)(F)(i);
(3) Are enrolled in an institution that
is Student and Exchange Visitor
Program (SEVP)-certified for enrollment
of F–1 nonimmigrant students;
(4) Are maintaining F–1 status; and
(5) Are experiencing severe economic
hardship as a direct result of the current
crisis in Haiti.
This notice applies to F–1
nonimmigrant students in an approved
private school in grades kindergarten
through grade 12, public school in
grades 9 through 12, and undergraduate
and graduate education. An F–1
nonimmigrant student covered by this
notice who transfers to another SEVPcertified academic institution remains
eligible for the relief provided by means
of this notice. Nothing in this notice
affects the applicability of federal and
state labor laws limiting the
employment of minors.
Why is DHS taking this action?
As a result of the current crisis in
Haiti, the Secretary designated Haiti for
Temporary Protected Status (TPS) for 18
months, effective August 3, 2021
through February 3, 2023, based on
extraordinary and temporary conditions
1 Because the suspension of requirements under
this notice applies throughout an academic term
during which the suspension is in effect, DHS
considers an F–1 nonimmigrant student who
engaged in a reduced course load or employment
(or both) after this notice is effective to be engaging
in a ‘‘full course of study,’’ see 8 CFR 214.2(f)(6),
and eligible for employment authorization, through
the end of any academic term for which such
student is matriculated as of February 3, 2023,
provided the student satisfies the minimum course
load requirements in this notice. DHS also
considers students who engage in online
coursework pursuant to ICE coronavirus disease
2019 (COVID–19) guidance for nonimmigrant
students to be in compliance with regulations while
such guidance remains in effect. See ICE Guidance
on COVID–19, available at https://www.ice.gov/
coronavirus [last visited May 2021].

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