Agency Information Collection Activities: Proposed Collection; Comment Request, 14952-14953 [2020-05274]
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Federal Register / Vol. 85, No. 51 / Monday, March 16, 2020 / 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:
Peter Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov. 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to receive copies of unpublished patent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.
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
Method of Vaccination With an
Attenuated RSV Vaccine Formulation
Description of Technology: Acute
respiratory infections during early
childhood constitute a major human
health burden. Human respiratory
syncytial virus (RSV) is the most
common and important viral cause of
severe acute pediatric respiratory
infections worldwide. Mortality due to
RSV in the post-neonatal (28 days to 1
year old) population is second only to
malaria. It is estimated that RSV causes
34 million lower respiratory tract
infections, 4 million hospitalizations,
and 66,000–199,000 deaths every year
in children less than 5 years of age.
Most mortality occurs in the developing
world where clinical care is less
accessible. Mortality is low in the
developed countries, but the morbidity
is substantial: In the United States
alone, RSV is associated with an
estimated 132,000–172,000
hospitalizations annually in children
less than 5 years old. There is not yet
available a vaccine or an effective
antiviral drug suitable for routine use.
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This application claims a method of
vaccinating a human subject against
Respiratory Syncytial Virus (RSV) by
administering a composition comprising
an immunogenic amount of a
recombinant RSV particle to the subject.
An embodiment of the composition
comprising the recombinant RSV
particle was evaluated as a live
intranasal vaccine in adults, RSVseropositive children and RSVseronegative children. When results in
RSV-seronegative children were
compared to those achieved with the
previous leading live attenuated RSV
candidate vaccine, vaccine virus
shedding was significantly more
restricted, yet the post-vaccination RSVneutralizing serum antibody achieved
was significantly greater. Surveillance
during the subsequent RSV season
showed that several RSV-seronegative
recipients had substantial rises of RSVneutralizing serum antibodies indicative
of exposure to RSV, and yet without
reported RSV-associated illness,
suggesting that the vaccine was
protective yet primed for anamnestic
responses to RSV. Thus, the
composition comprising the
recombinant RSV particle was
intrinsically superior at eliciting
protective antibody in the subjects.
Surprisingly, a single dose of the
composition was sufficient to provide
the greater antibody response and
protective effect in seronegative and/or
RSV-naive infants and children of less
than about 24 months of age. This was
an unexpected result, as it is currently
anticipated that vaccination against RSV
using a live, attenuated RSV vaccine
will require administration of multiple
doses, at least two or three at a
minimum, in a single vaccination
season to provide protective result.
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 therapeutics
• Viral diagnostics
• Vaccine research
Competitive Advantages:
• Ease of manufacture
• Adjuvant unnecessary
• Favorable safety profile in clinical
trials
Development Stage:
• In vivo data assessment (human)
Inventors: Ursula Buchholz (NIAID),
Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–067–2016–0 —U.S. Provisional
Application Nos. 62/251,030, filed
November 4, 2015, 62/259,472, filed
PO 00000
Frm 00081
Fmt 4703
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November 24, 2015, and 62/263,405,
filed December 4, 2015, PCT Patent
Application Number PCT/US2016/
060672, filed November 4, 2016,
European Patent Application Number
1694904.9, filed November 4, 2016
(pending), United States Patent
Application Number 15/773,653, filed
May 4, 2018 (pending).
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; peter.soukas@nih.gov.
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;
peter.soukas@nih.gov.
Dated: March 10, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–05294 Filed 3–13–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer at (240) 276–
0361.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
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Federal Register / Vol. 85, No. 51 / Monday, March 16, 2020 / Notices
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: National Survey of
Substance Abuse Treatment Services
(N–SSATS) (OMB No. 0930–0106)—
Extension
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is requesting an extension of
the National Survey of Substance Abuse
Treatment (N–SSATS) data collection
(OMB No. 0930–0106), which expires
on September 30, 2020. N–SSATS
provides both national and state-level
data on the numbers and types of
patients treated and the characteristics
of facilities providing substance abuse
treatment services. It is conducted
under the authority of Section 505 of the
Public Health Service Act (42 U.S.C.
290aa–4) to meet the specific mandates
for annual information about public and
private substance abuse treatment
providers and the clients they serve.
This request includes:
• Collection of N–SSATS, which is an
annual survey of substance abuse
treatment facilities; and
• Updating of the Inventory of
Behavioral Health Services (I–BHS)
which is the facility universe for the
N–SSATS. I–BHS is also the facility
universe for the annual survey of mental
health treatment facilities, the National
Mental Health Services Survey
(N–MHSS). The I–BHS includes all
substance abuse treatment and mental
health treatment facilities known to
SAMHSA. (The N–MHSS data
collection is covered under OMB No.
0930–0119.)
The information in I–BHS and
N–SSATS is needed to assess the nature
Number of
respondents
Type of respondent and activity
Responses
per
respondent
and extent of these resources, to identify
gaps in services, and to provide a
database for treatment referrals. Both
I–BHS and N–SSATS are components of
the Behavioral Health Services
Information System (BHSIS).
The request for OMB approval will
include a request to update the I–BHS
facility listing on a continuous basis and
to conduct the N–SSATS and the
between cycle N–SSATS (N–SSATS BC)
in 2021, 2022, and 2023. The N–SSATS
BC is a procedure for collecting services
data from newly identified facilities
between main cycles of the survey and
will be used to improve the listing of
treatment facilities in the online
Behavioral Health Treatment Services
Locator.
Estimated annual burden for the
BHSIS activities is shown below:
Total
responses
Hours per
response
Total burden
hours
States
I–BHS Online 1 .....................................................................
56
75
4,200
0.08
336
State Subtotal ...............................................................
56
........................
4,200
........................
336
Facilities
I–BHS application 2 ..............................................................
Augmentation screener ........................................................
N–SSATS questionnaire ......................................................
N–SSATS BC .......................................................................
800
1,300
17,000
1,000
1
1
1
1
800
1,300
17,000
1,000
0.08
0.08
0.67
0.58
64
104
11,333
580
Facility Subtotal ............................................................
20,100
........................
20,100
........................
12,081
Total .......................................................................
20,156
........................
24,300
........................
12,417
1 States
use the I–BHS Online system to submit information on newly licensed/approved facilities and on changes in facility name, address,
status, etc.
2 New facilities complete and submit the online I–BHS application form in order to get listed on the Inventory.
Send comments to Carlos Graham,
SAMHSA Reports Clearance Officer,
5600 Fisher Lane, Room 15E57A,
Rockville, MD 20852 OR email him a
copy at carlos.graham@samhsa.hhs.gov.
Written comments should be received
by May 15, 2020.
Carlos Graham,
Social Science Analyst.
[FR Doc. 2020–05274 Filed 3–13–20; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
Determination Pursuant to Section 102
of the Illegal Immigration Reform and
Immigrant Responsibility Act of 1996,
as Amended
Office of the Secretary,
Department of Homeland Security.
AGENCY:
ACTION:
Notice of determination.
The Acting Secretary of
Homeland Security has determined,
pursuant to law, that it is necessary to
waive certain laws, regulations, and
other legal requirements in order to
ensure the expeditious construction of
barriers and roads in the vicinity of the
international land border in Val Verde
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SUMMARY:
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County, Texas, and Maverick County,
Texas.
DATES: This determination takes effect
on March 16, 2020.
SUPPLEMENTARY INFORMATION: Important
mission requirements of the Department
of Homeland Security (‘‘DHS’’) include
border security and the detection and
prevention of illegal entry into the
United States. Border security is critical
to the nation’s national security.
Recognizing the critical importance of
border security, Congress has mandated
DHS to achieve and maintain
operational control of the international
land border. Secure Fence Act of 2006,
Public Law 109–367, section 2, 120 Stat.
2638 (Oct. 26, 2006) (8 U.S.C. 1701
note). Congress defined ‘‘operational
control’’ as the prevention of all
unlawful entries into the United States,
including entries by terrorists, other
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[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Pages 14952-14953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05274]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer at (240) 276-0361.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on
[[Page 14953]]
respondents, including through the use of automated collection
techniques or other forms of information technology.
Proposed Project: National Survey of Substance Abuse Treatment Services
(N-SSATS) (OMB No. 0930-0106)--Extension
The Substance Abuse and Mental Health Services Administration
(SAMHSA) is requesting an extension of the National Survey of Substance
Abuse Treatment (N-SSATS) data collection (OMB No. 0930-0106), which
expires on September 30, 2020. N-SSATS provides both national and
state-level data on the numbers and types of patients treated and the
characteristics of facilities providing substance abuse treatment
services. It is conducted under the authority of Section 505 of the
Public Health Service Act (42 U.S.C. 290aa-4) to meet the specific
mandates for annual information about public and private substance
abuse treatment providers and the clients they serve.
This request includes:
Collection of N-SSATS, which is an annual survey of
substance abuse treatment facilities; and
Updating of the Inventory of Behavioral Health Services
(I-BHS) which is the facility universe for the N-SSATS. I-BHS is also
the facility universe for the annual survey of mental health treatment
facilities, the National Mental Health Services Survey (N-MHSS). The I-
BHS includes all substance abuse treatment and mental health treatment
facilities known to SAMHSA. (The N-MHSS data collection is covered
under OMB No. 0930-0119.)
The information in I-BHS and N-SSATS is needed to assess the nature
and extent of these resources, to identify gaps in services, and to
provide a database for treatment referrals. Both I-BHS and N-SSATS are
components of the Behavioral Health Services Information System
(BHSIS).
The request for OMB approval will include a request to update the
I-BHS facility listing on a continuous basis and to conduct the N-SSATS
and the between cycle N-SSATS (N-SSATS BC) in 2021, 2022, and 2023. The
N-SSATS BC is a procedure for collecting services data from newly
identified facilities between main cycles of the survey and will be
used to improve the listing of treatment facilities in the online
Behavioral Health Treatment Services Locator.
Estimated annual burden for the BHSIS activities is shown below:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Type of respondent and activity respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
States
----------------------------------------------------------------------------------------------------------------
I-BHS Online \1\................ 56 75 4,200 0.08 336
-------------------------------------------------------------------------------
State Subtotal.............. 56 .............. 4,200 .............. 336
----------------------------------------------------------------------------------------------------------------
Facilities
----------------------------------------------------------------------------------------------------------------
I-BHS application \2\........... 800 1 800 0.08 64
Augmentation screener........... 1,300 1 1,300 0.08 104
N-SSATS questionnaire........... 17,000 1 17,000 0.67 11,333
N-SSATS BC...................... 1,000 1 1,000 0.58 580
-------------------------------------------------------------------------------
Facility Subtotal........... 20,100 .............. 20,100 .............. 12,081
-------------------------------------------------------------------------------
Total................... 20,156 .............. 24,300 .............. 12,417
----------------------------------------------------------------------------------------------------------------
\1\ States use the I-BHS Online system to submit information on newly licensed/approved facilities and on
changes in facility name, address, status, etc.
\2\ New facilities complete and submit the online I-BHS application form in order to get listed on the
Inventory.
Send comments to Carlos Graham, SAMHSA Reports Clearance Officer,
5600 Fisher Lane, Room 15E57A, Rockville, MD 20852 OR email him a copy
at [email protected]. Written comments should be received by
May 15, 2020.
Carlos Graham,
Social Science Analyst.
[FR Doc. 2020-05274 Filed 3-13-20; 8:45 am]
BILLING CODE 4162-20-P
