Agency Information Collection Request; 60-Day Public Comment Request, 8305-8306 [2020-02846]
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Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Assistant Secretary for Administration;
Delegation of Authority
Notice is hereby given that I have
amended the delegation of authority to
the Assistant Secretary for Preparedness
and Response (ASPR); the Director,
Centers for Disease Control and
Prevention (CDC); the Administrator,
Health Resources and Services
Administration (HRSA); the Director,
National Institutes for Health (NIH); the
Director, Office of Global Affairs (OGA);
and the Administrator, Substance Abuse
and Mental Health Services
Administration (SAMHSA), specifically
the authority vested in the Secretary, by
section 212(l) of the Department of
Defense and Labor, Health and Human
Services, and Education Appropriations
Act, 2019 and Continuing
Appropriations Act, 2019 (FY 19 HHS
Appropriations Act) Public Law 115–
245, division B, title II, (September 28,
2018), or substantially similar
authorities vested in me in the future by
Congress, in order to carry out
international health activities, including
HIV/AIDS and other infectious disease,
chronic and environmental disease, and
other health activities abroad. Section
212(l) of the FY19 HHS Appropriations
Act and section 212(1) of the Further
Consolidated Appropriations Act, 2020,
Public Law 116–94, division A, title II,
(December 20, 2019) permit the
Secretary of HHS to exercise authority
equivalent to that available to the
Secretary of State under 22 U.S.C.
2669(c) to award personal services
contracts for work performed in foreign
countries.
The authority delegated herein
includes the authority to determine the
necessity of negotiating, executing, and
performing such contracts without
regard to statutory provisions as relate
to the negotiation, making, and
performance of contracts and
performance of work in the United
States. This authority is immediately
revoked in the event that any
subsequent fiscal year HHS
appropriations act does not contain the
provision currently in section 212(1) or
substantially similar authority.
The Director, CDC, may redelegate
this authority to the Chief Operating
Officer, CDC, through Fiscal Year 2021
from this date of signature to respond to
current and any future Ebola, polio, and
coronavirus outbreaks. This authority
may not be further be redelegated except
as noted above.
The delegatees shall consult with the
Secretary of State and relevant Chief of
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18:34 Feb 12, 2020
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Mission to ensure that this authority is
exercised in a manner consistent with
section 207 of the Foreign Service Act
of 1980 and other applicable statutes
administered by the Department of
State.
This amended delegation became
effective upon date of signature. In
addition, I hereby affirm and ratify any
actions taken by you or your
subordinates which involved the
exercise of the authorities delegated
herein, or substantially similar
authorities vested in me by prior annual
HHS appropriations acts, prior to the
effective date of the delegation.
Dated: February 7, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–02944 Filed 2–12–20; 8:45 am]
BILLING CODE 4151–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before April 13, 2020.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
and project title for reference, to
Sherrette.funn@hhs.gov, or call the
Reports Clearance Officer, Sherrette
Funn (202) 795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
SUMMARY:
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8305
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Substance Use
Disorder Patient Placement Criteria
Used By States.
Type of Collection: New.
The Office of the Assistant Secretary
for Planning and Evaluation (ASPE) at
the U.S. Department of Health and
Human Services (HHS) is requesting
Office of Management and Budget
(OMB) approval for a one-time survey of
state agencies regarding their use of
substance use disorder (SUD) patient
placement criteria and assessment tools.
The proposed survey is one component
of a larger project to assess the
feasibility of gathering and utilizing
needs assessment data to identify and
address unmet patient needs by levels of
care. Results from this survey will
provide ASPE with information about
the types of patient placement data
states collect and maintain, and the
degree to which the data can be used to
understand the SUD treatment gap.
These results will provide ASPE with
information that can be used to develop
a multistate dataset of needs assessment
that can be updated over time. Such a
dataset is necessary for understanding
and addressing treatment needs in the
nation on an ongoing basis.
The 17-question survey requests
information related to state
requirements for using patient
placement criteria and assessment tools
for individuals with SUD. Additional
questions ask how data from the
placement criteria and/or assessment
tools are maintained; if level of care data
has been used to help determine service
gaps and need for greater capacity; and
whether the respondent could provide
web links to available information on
the criteria used in their state. Two
individuals from each state and the
District of Columbia will be invited to
respond to the survey. Respondents will
be representatives from each state’s
Single State Authority (SSA) and the
Medicaid Agency. An eighty-five
percent response rate is anticipated,
resulting in an estimated 87 total
participants.
This project falls under Section 301 of
the Public Health Service Act (42U.S.C.
241) [280–1a] which authorizes the
Office of the Secretary to conduct and
coordinate studies relating to the causes,
diagnosis, treatment, control, and
prevention of physical and mental
diseases. The total annual burden hours
estimated for this information collection
request are summarized in the table
below.
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Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Forms
Survey on SUD Placement Criteria .................................................................
Dated: February 5, 2020.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2020–02846 Filed 2–12–20; 8:45 am]
BILLING CODE 4150–05–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:
Dianca Finch, Ph.D., 240–669–5503;
dianca.finch@nih.gov. 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.
SUPPLEMENTARY INFORMATION:
Technology description follows:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
Ebola Virus Glycoprotein-Specific
Monoclonal Antibodies and Uses
Thereof Description of Technology
Ebola virus is a large, negative-strand
RNA virus composed of 7 genes
encoding viral proteins, including a
single glycoprotein (GP). The virus is
responsible for causing Ebola virus
disease (EVD), formerly known as Ebola
hemorrhagic fever (EHF), in humans. In
particular, Bundibugyo (BDBV), Zaire
(EBOV), and Sudan (SUDV) species
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87
have been associated with large
outbreaks of EVD in Africa and reported
case fatality rates of up to 90%.
Transmission of Ebola virus to humans
is not yet fully understood but is likely
due to incidental exposure to infected
animals. EVD spreads through humanto-human transmission, with infection
resulting from direct contact with blood,
secretions, organs or other bodily fluids
of infected people, and indirect contact
with environments contaminated by
such fluids.
EVD has an incubation period of 2 to
21 days (7 days on average, depending
on the strain) followed by a rapid onset
of non-specific symptoms such as fever,
extreme fatigue, gastrointestinal
complaints, abdominal pain, anorexia,
headache, myalgias and/or arthralgias.
While prior outbreaks of EVD have
been localized to regions of Africa, there
is a potential threat of spread to other
countries given the frequency of
international travel. The 2014 outbreak
in West Africa was first recognized in
March 2014, and as of April 13, 2016,
the number of cases far exceeded the
largest prior EVD outbreak with a
combined total (suspected, probable,
and laboratory-confirmed) 28616 cases
and 11310 deaths (case fatality rate =
39.5%). The largest previous outbreak
occurred in Uganda in 2000–2001 with
425 cases and 224 deaths (case-fatality
rate = 53%).
Viruses in the Filoviridae family are
also categorized as potential threats for
use as biological weapons due to ease of
dissemination and transmission, and
high levels of mortality. Currently, no
effective therapies or FDA-licensed
vaccines exist for any member of
Filoviridae family of viruses.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
developed eight high-affinity human
monoclonal antibodies, specifically
EboV.YD.01, EboV.YD.02, EboV.YD.03,
and EboV.YD.04, EboV.YD.05,
EboV.YD.06, EboV.YD.07 and
EboV.YD.08 which bind with
nanomolar affinity against Ebola virus
glycoprotein. The human monoclonal
antibodies have been assessed by
functional assays, epitope mapping,
affinity measurements and in vitro
neutralization assays.
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Number of
responses per
respondent
Average
burden per
response
(hours)
1
Total annual
burden
(hours)
10/60
14.5
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:
• Prevention of acquisition of Ebola
Zaire virus.
• Antibody therapy for people
exposed to Ebola Zaire virus.
• Diagnostics for Ebola Zaire virus.
Competitive Advantages:
• High-affinity neutralizing
antibodies (mAbs), targeting Ebola virus
(EBOV) glycoprotein from a human
Ebolavirus vaccine.
• Currently, there are no Food and
Drug Administration (FDA)-approved
vaccines or therapeutics available for
prevention, post-exposure, or treatment
for EBOV.
• The EboV.YD.01–EboV.YD.08
antibodies can be combined with other
biologicals and vaccines for prevention
and therapy of Ebola Zaire infection/
disease.
Development Stage: Preclinical
Research.
Inventors: Nancy J. Sullivan, Ph.D.
(NIAID); John Misasi, Ph.D. (NIAID).
Intellectual Property: HHS Reference
Number E–061–2018 includes U.S.
Provisional Patent Application Number
62/782,809, filed 12/20/2018, and PCT
Application Number PCT/US2019/
067423, filed 12/19/2019.
Licensing Contact: To license this
technology, please contact Dianca
Finch, Ph.D., 240–669–5503;
dianca.finch@nih.gov.
Dated: February 4, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–02916 Filed 2–12–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8305-8306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02846]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before April 13,
2020.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-New-60D and
project title for reference, to [email protected], or call the
Reports Clearance Officer, Sherrette Funn (202) 795-7714.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Substance Use Disorder Patient Placement
Criteria Used By States.
Type of Collection: New.
The Office of the Assistant Secretary for Planning and Evaluation
(ASPE) at the U.S. Department of Health and Human Services (HHS) is
requesting Office of Management and Budget (OMB) approval for a one-
time survey of state agencies regarding their use of substance use
disorder (SUD) patient placement criteria and assessment tools. The
proposed survey is one component of a larger project to assess the
feasibility of gathering and utilizing needs assessment data to
identify and address unmet patient needs by levels of care. Results
from this survey will provide ASPE with information about the types of
patient placement data states collect and maintain, and the degree to
which the data can be used to understand the SUD treatment gap. These
results will provide ASPE with information that can be used to develop
a multistate dataset of needs assessment that can be updated over time.
Such a dataset is necessary for understanding and addressing treatment
needs in the nation on an ongoing basis.
The 17-question survey requests information related to state
requirements for using patient placement criteria and assessment tools
for individuals with SUD. Additional questions ask how data from the
placement criteria and/or assessment tools are maintained; if level of
care data has been used to help determine service gaps and need for
greater capacity; and whether the respondent could provide web links to
available information on the criteria used in their state. Two
individuals from each state and the District of Columbia will be
invited to respond to the survey. Respondents will be representatives
from each state's Single State Authority (SSA) and the Medicaid Agency.
An eighty-five percent response rate is anticipated, resulting in an
estimated 87 total participants.
This project falls under Section 301 of the Public Health Service
Act (42U.S.C. 241) [280-1a] which authorizes the Office of the
Secretary to conduct and coordinate studies relating to the causes,
diagnosis, treatment, control, and prevention of physical and mental
diseases. The total annual burden hours estimated for this information
collection request are summarized in the table below.
[[Page 8306]]
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Forms respondents responses per response burden
respondent (hours) (hours)
----------------------------------------------------------------------------------------------------------------
Survey on SUD Placement Criteria................ 87 1 10/60 14.5
----------------------------------------------------------------------------------------------------------------
Dated: February 5, 2020.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2020-02846 Filed 2-12-20; 8:45 am]
BILLING CODE 4150-05-P
