30 day FRN

39454

Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices

withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PROLIXIN
(fluphenazine hydrochloride) tablets, 1
mg, 2.5 mg, 5 mg, and 10 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17026 Filed 8–8–18; 8:45 am]
BILLING CODE 4164–01–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:
Amy F. Petrik, Ph.D., 240–627–3721,
[email protected]. 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to receive copies of unpublished patent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.

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SUMMARY:

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SUPPLEMENTARY INFORMATION:
Technology description follows.

Stabilized Group 2 Influenza
Hemagglutinin Stem Region Trimers
and Uses Thereof
Description of Technology:
Researchers at the Vaccine Research
Center of the National Institute of
Allergy and Infectious Diseases (NIAID)
have designed influenza vaccine
candidates based on group 2 influenza
hemagglutinin (HA) proteins. These
group 2 HA proteins were engineered to
remove the highly variable head region
and stabilize the remaining stem region.
The researchers then fused the
engineered group 2 HA stabilized stem
with a ferritin subunit. The resulting
fusion protein can self-assemble into
nanoparticles which display group 2 HA
stem domain trimers on their surface.
These immunogens elicit crossreactive antibodies to group 2 influenza
viruses and could be used in
combination with group 1 HA stemferritin immunogens as a universal
influenza vaccine. Interestingly, a recent
study by Andrews et al., Sci. Immunol.
2, eaan2676 (2017), suggests that crossreactive group 1/group 2 HA stem
antibodies may be more likely to be
elicited in humans by a group 2 HA
immunogen.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• Use as a broadly protective influenza
vaccine
Competitive Advantages:
• Elicits antibodies to both group 1 and
group 2 influenza A viruses
• Nucleic acid or recombinant proteinbased vaccine
• Increased ease of production
compared to current seasonal
influenza vaccines
Development Stage:
• In vivo (animal studies)
Inventors: Jeffrey C. Boyington,
Barney S. Graham, John R. Mascola,
Hadi M. Yassine, Syed M. Moin,
Lingshu Wang, Kizzmekia S. Corbett,
Masaru Kanekiyo (all from NIAID).
Intellectual Property: HHS Reference
Number E–228–2016 includes U.S.
Provisional 62/383,267 filed 2
September 2016 and PCT Patent
Application No. PCT/US2017/049894
filed 1 September 2017 (pending).
Related Intellectual Property: HHS
Reference Number E–293–2011.
Licensing Contact: Dr. Amy Petrik,
240–627–3721; [email protected].

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Dated: July 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–17036 Filed 8–8–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0138]

Agency Information Collection
Activities: Biometric Identity
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 30-Day notice and request for
comments; revision and extension of an
existing collection of information.
AGENCY:

The Department of Homeland
Security, U.S. Customs and Border
Protection will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
DATES: Comments are encouraged and
will be accepted (no later than
September 10, 2018]) to be assured of
consideration.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to dhsdeskofficer@
omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177,
Telephone number (202) 325–0056 or
via email [email protected]. Please
note that the contact information
provided here is solely for questions
regarding this notice. Individuals
seeking information about other CBP
programs should contact the CBP
National Customer Service Center at
877–227–5511, (TTY) 1–800–877–8339,
SUMMARY:

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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
or CBP website at https://www.cbp
.gov/.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on the
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This proposed information
collection was previously published in
the Federal Register (83 FR 24326) on
May 25, 2018, allowing for a 60-day
comment period. This notice allows for
an additional 30 days for public
comments. This process is conducted in
accordance with 5 CFR 1320.8. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points: (1) 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) 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)
suggestions to enhance the quality,
utility, and clarity of the information to
be collected; and (4) suggestions to
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. The
comments that are submitted will be
summarized and included in the request
for approval. All comments will become
a matter of public record.

sradovich on DSK3GMQ082PROD with NOTICES

Overview of This Information
Collection
Title: Biometric Identity.
OMB Number: 1651–0138.
Type of Review: Revision and
Extension (with change).
Current Actions: This submission is
being made to revise the information
collection and extend the expiration
date with a change to the burden hours
due to an increase in the number of
respondents in agency estimates and
separating the different biometric
modalities. Proposed Change: CBP is
proposing to revise this collection of
information to include the collection of
biometrics from certain travelers
entering and exiting the United States in
vehicles. This collection will not
impose a time burden on the
respondents and may reduce wait times
at the ports of entry and exit.
Affected Public: Individuals.

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Abstract: In order to enhance national
security, the Department of Homeland
Security is developing a biometric based
entry and exit system capable of
improving the information resources
available to immigration and border
management decision-makers. These
biometrics may include: Digital
fingerprint scans, facial images, iris
images or other biometrics. Biometrics
may be collected from certain travelers
entering or exiting the United States in
order to verify identity, determine
admissibility of those seeking entry into
the United States, confirm exit from the
United States for the purpose of tracking
aliens who have overstayed their visa or
are otherwise illegally present in the
United States, prevent visa fraud, and
identify known or suspected criminals
or terrorists. CBP will only store
biometric data from those aliens
specified in 8 CFR 215.8 and 8 CFR
235.1. U.S. Citizens and aliens who are
generally exempt from biometric
collection but voluntarily participate in
biometric collection will have their
biometrics deleted from DHS systems.
CBP continues to test and evaluate
different technological and operational
changes to improve the accuracy and
speed of biometric collection.
The federal statutes that mandate DHS
to create a biometric entry and exit
system include: Section 2(a) of the
Immigration and Naturalization Service
Data Management Improvement Act of
2000 (DMIA), Public Law 106–215, 114
Stat. 337 (2000); Section 205 of the Visa
Waiver Permanent Program Act of 2000,
Public Law 106–396, 114 Stat. 1637,
1641 (2000); Section 414 of the Uniting
and Strengthening America by
Providing Appropriate Tools Required
to Intercept and Obstruct Terrorism Act
of 2001 (USA PATRIOT Act), Public
Law 107–56, 115 Stat. 272, 353 (2001);
Section 302 of the Enhanced Border
Security and Visa Entry Reform Act of
2002 (Border Security Act), Public Law
107–173, 116 Stat. 543, 552, (2002);
Section 7208 of the Intelligence Reform
and Terrorism Prevention Act of 2004
(IRTPA), Public Law 108–458, 118 Stat.
3638, 3817 (2004); Section 711 of the
Implementing Recommendations of the
9/11 Commission Act of 2007, Public
Law 110–53, 121 Stat. 266 (2007),
Consolidated Appropriations Act, 2016,
Public Law 114–113, 129 Stat. 2242,
2493 (2016), Section 110 of the Illegal
Immigration Reform and Immigrant
Responsibility Act of 1996, Public Law
104–208, 110 Stat. 3009–546 (1997),
Section 802 of the Trade Facilitation
and Trade Enforcement Act of 2015,
Public Law 114–125, 130 Stat. 122, 199
(2015), and Sections 214, 215(a), 235(a),

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39455

262(a), 263(a) and 264(c) of the
Immigration and Nationality Act of
1952, as amended, 8 U.S.C. 1184,
1185(a), 1225(a), 1302(a)(1303(a),
1304(c) and 1365b.
Fingerprint Modality
Estimated Number of Respondents:
58,657,882.
Estimated Time per Response: .0097
hours.
Estimated Total Annual Burden
Hours: 568,981.
Facial/Iris Modality
Estimated Number of Respondents:
54,542,118.
Estimated Time per Response: .0025
hours.
Estimated Total Annual Burden
Hours: 136,355.
Biometrics Collected From Travelers in
Vehicles
Estimated Number of Respondents:
300,000.*
Estimated Time per Response: None.
Estimated Total Annual Burden
Hours: None.
* Vehicle time per Respondent is
estimated at zero due to no physical
response required from the respondent.
Dated: August 6, 2018.
Seth D. Renkema,
Branch Chief, Economic Impact Analysis
Branch, U.S. Customs and Border Protection.
[FR Doc. 2018–17079 Filed 8–8–18; 8:45 am]
BILLING CODE 9111–14–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2018–0002; Internal
Agency Docket No. FEMA–B–1843]

Proposed Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:

Comments are requested on
proposed flood hazard determinations,
which may include additions or
modifications of any Base Flood
Elevation (BFE), base flood depth,
Special Flood Hazard Area (SFHA)
boundary or zone designation, or
regulatory floodway on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports for
the communities listed in the table
below. The purpose of this notice is to
seek general information and comment

SUMMARY:

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