30-day FRN

30-day FRN2018-21818.pdf

Request for Generic Clearance to Conduct Voluntary Customer/Partner Surveys(NLM)

30-day FRN

OMB: 0925-0476

Document [pdf]
Download: pdf | pdf
50668

Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices

neutralizing antibody.’’ Science
352.6287 (2016): 828–833.
(b) Xu, Kai, et al. ‘‘Epitope-based
vaccine design yields fusion
peptide-directed antibodies that
neutralize diverse strains of HIV–
1.’’ Nature Medicine 24, 857–867
(2018).
Intellectual Property: HHS Reference
Number E–279–2016 includes U.S.
Provisional Patent Application Number
62/403,266 filed 10/03/2016 and PCT
Application Number PCT/US2017/
054959 filed 10/03/2017 (pending).
Licensing Contact: Barry Buchbinder,
Ph.D., 240–627–3678;
[email protected]
Dated: September 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–21762 Filed 10–5–18; 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.

SUMMARY:

amozie on DSK3GDR082PROD with NOTICES1

FOR FURTHER INFORMATION CONTACT:

Peter Soukas, J.D., 301–594–8730;
[email protected]. 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to receive copies of unpublished patent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.

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Recombinant RSV B1 Expressing eGFP
as a Reporter Gene
Description of Technology: The
inventors have created a reverse
genetics system for RSV strain B1 of
antigenic subgroup B encoding a
replication-competent recombinant RSV
that contains a codon-optimized G ORF
and expresses enhanced green
fluorescence protein (GFP). There are
two antigenic subgroups of RSV,
subgroups A and B, and most of the
available information and reagents are
for subgroup A. Immunity against either
subgroup has reduced effectiveness in
restricting the heterologous subgroup,
suggesting that an effective RSV vaccine
might need to contain both subgroups.
The sequence of the wild type G gene
was refractory to cloning into full-length
antigenomic cDNA in E. coli, and so the
inventors made and successfully used a
codon optimized version. In addition,
the inventors inserted an eGFP gene into
the first gene position (promoter
proximal). The resulting virus is
replication-competent and efficiently
expresses GFP in infected cells. This
virus can be used as a tool to detect
RSV-neutralizing antibodies to RSV
subgroup B in a plaque-reduction assay.
It also can be used to evaluate RSV
infection in vitro and in vivo using GFP
fluorescence to track infection. The
antigenomic cDNA clone also provides
the starting material for making liveattenuated subgroup B-specific RSV
vaccine candidates containing defined
mutations. These defined mutations can
include ones that we previously
developed for RSV subgroup A, and
include stabilized point mutations,
stabilized codon-deletions, and genedeletions.
The present invention provides a
reverse genetics system encoding strain
B1 of RSV subgroup B containing a
codon-optimized G ORF and encoding
eGFP. This provides a tool for RSV
subgroup B serology assays, for tracking
RSV infection, and a starting point for
making attenuated subgroup B strains
for vaccine purposes.
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:
• Viral diagnostics
• Vaccine research
• Serology assays
• Vaccine manufacture
Competitive Advantages:
• Ease of manufacture
• Unique research tool
Development Stage:

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• In vitro data assessment
Inventors: Ursula Buchholz (NIAID),
Peter Collins (NIAID).
Publications: None.
Intellectual Property: HHS Reference
No. E–159–2018–0.
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; [email protected].
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;
[email protected].
Dated: September 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–21767 Filed 10–5–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Generic Clearance
To Conduct Voluntary Customer/
Partner Surveys (NLM)
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:

Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
[email protected] or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
ADDRESSES:

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50669

Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices
the data collection plans and
instruments, contact: contact: David
Sharlip, National Library of Medicine,
Building 38A, Room B2N12, 8600
Rockville Pike, Bethesda, MD 20894, or
call non-toll-free number 301–827–6361
or email your request to sharlipd@
mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on July 20, 2018, pages 34599–
34600 (83 FR 34599–34600) and
allowed 60 days for public comment.
NLM received one comment in response
to the 60-Day Federal Register Notice.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Library of Medicine
(NLM), National Institutes of Health,
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.

health information, drawing on research
in lay terminology, graphical and
multimedia presentations; (2) assisting
those providing health information to
the public to make effective use of
electronic services through internet
connections, training, and other means,
with an emphasis on those serving
minority groups, low income
populations, and seniors; (3) promoting
integrations of NLM services with other
electronic services covering regional,
state, or local health information; and
(4) conducting and supporting research,
development, and evaluation of the
public’s health information needs,
information seeking behavior and
learning styles, information systems that
meet the public’s needs, and the impact
of access to information.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
750.

In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Generic
Clearance to Conduct Voluntary
Customer/Partner Surveys (NLM), 0925–
0476, Expiration Date 09/30/2018,
REINSTATEMENT WITHOUT
CHANGE, National Library of Medicine
(NLM), National Institutes of Health
(NIH).
Need and Use of Information
Collection: In 1994, the NLM was
designated a ‘‘Federal Reinvention
Laboratory’’ with a major objective of
improving its methods of delivering
information to the public. At a
minimum, necessary elements in
improving the delivery of information
include: (1) Development of easy-to-use
access and delivery mechanisms that
promote the public’s understanding of

ESTIMATED ANNUALIZED BURDEN HOURS
Table A.12–1
Type of collection

Type of
respondents

Customer Satisfaction Surveys ..............................
Focus Groups .........................................................
Usability and Pilot Testing .....................................
Interviews or Small Discussion Groups .................

General Public ............
Health Professionals ...
Librarians ....................
Health Educators ........

Total ................................................................

.....................................

Dated: September 21, 2018.
David H. Sharlip,
Project Clearance Liaison, National Library
of Medicine, National Institutes of Health.

Annual
frequency per
response

Average time
per response
(minutes/hour)

1,000
500
500
500

1
1
1
1

20/60
15/60
20/60
15/60

333
125
167
125

2,500

2,500

........................

750

Number of
respondents

dated October 8, 2017, and related
determinations.

Federal Emergency
Management Agency, DHS.
ACTION: Notice.

The change occurred on August
29, 2018.
FOR FURTHER INFORMATION CONTACT:
Dean Webster, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street SW,
Washington, DC 20472, (202) 646–2833.
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) hereby gives notice that
pursuant to the authority vested in the
Administrator, under Executive Order
12148, as amended, Thomas J. McCool,
of FEMA is appointed to act as the
Federal Coordinating Officer for this
emergency.
This action terminates the
appointment of Allan Jarvis as Federal
Coordinating Officer for this emergency.

This notice amends the notice
of an emergency declaration for the
State of Florida (FEMA–3395–EM),

The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora

[FR Doc. 2018–21818 Filed 10–5–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–3395–
EM; Docket ID FEMA–2018–0001]

Florida; Amendment No. 3 to Notice of
an Emergency Declaration
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Estimates of Annual Burden Hours

AGENCY:

SUMMARY:

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DATES:

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Total burden
hours

Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034,
Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to
Individuals and Households In Presidentially
Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance—
Disaster Housing Operations for Individuals
and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals
and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
Brock Long,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2018–21792 Filed 10–5–18; 8:45 am]
BILLING CODE 9111–11–P

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