Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28967-28968 [2020-10308]
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240)-276–7856;
Facsimile: (240)-276–5504; Email:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
Intellectual Property
E–097–2018–0: Anti-CD33 Chimeric
Antigen Receptors for Treatment of
Human Acute Myeloid Leukemia
1. U.S. Provisional Patent Application
62/643,015, filed March 14, 2018 (E–
097–2018–0–US–01);
2. International Patent Application
PCT/US2019/022,309, filed March 14,
2019 (E–097–2018–0–PCT–02)
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
fields of use may be limited to the
following:
An exclusive license to:
1. The development of a CD33specific logic-gated CAR-based
immunotherapy using autologous
human T cells transduced with
lentiviral vectors, wherein the viral
transduction leads to the expression of
a CAR that targets CD33 (comprised of
the CD33-binding domain referenced as
Hu195 or hP67.6 in the invention as
well as an intracellular signaling
domain), for the prophylaxis or
treatment of CD33-expressing cancers.
For clarity, ‘‘CD33-specific logic-gated
CAR-based immunotherapy’’ means
therapies where the CAR-expressing T
cells recognize CD33 and are engineered
to respond to one or more additional
antigens (but not necessarily all of the
signals).
2. The development of a CD33specific logic-gated CAR-based
immunotherapy using allogeneic human
NK cells transduced with lentiviral
vectors, wherein the viral transduction
leads to the expression of a CAR that
targets CD33 (comprised of the CD33binding domain referenced as Hu195 or
hP67.6 in the invention as well as an
intracellular signaling domain), for the
prophylaxis or treatment of CD33expressing cancers. For clarity, ‘‘CD33specific logic-gated CAR-based
immunotherapy’’ means therapies
where the CAR-expressing NK cells
recognize CD33 and are engineered to
respond to one or more additional
antigens (but not necessarily all of the
signals).
This technology discloses a CAR
therapy that targets CD33 by utilizing
the anti-CD33 binder known as Hu195
VerDate Sep<11>2014
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or hP67.6 for the treatment of
hematological malignancies. CD33 is a
validated immunotherapeutic target that
is expressed on the surface of the vast
majority of acute myelogenous leukemia
(AML) blasts and cells in chronic
myeloid leukemia-blast crisis (CML–
BC).
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 thirty (30) days from the date of
this published Notice, the National
Cancer Institute 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.
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 submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: May 7, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–10303 Filed 5–13–20; 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: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act. To request a
copy of these documents, call or email
the SAMHSA Reports Clearance Officer
on (240) 276–0361 or carlos.graham@
samhsa.hhs.gov.
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28967
Project: Projects for Assistance in
Transition from Homelessness (PATH)
Program Annual Report (OMB No.
0930–0205)—Revision
The Center for Mental Health Services
awards grants each fiscal year to each of
the states, the District of Columbia, the
Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern
Mariana Islands from allotments
authorized under the PATH program
established by Public Law 101–645, 42
U.S.C. 290cc-21 et seq., the Stewart B.
McKinney Homeless Assistance
Amendments Act of 1990 (section 521 et
seq. of the Public Health Service (PHS)
Act) and the 21st Century Cures Act
(114–255 Pub. L). Section 522 of the
PHS Act and the 21st Century Cures Act
requires that the grantee states and
territories must expend their payments
under the Act solely for making grants
to political subdivisions of the state, and
to nonprofit private entities (including
community-based veterans’
organizations and other community
organizations) for the purpose of
providing services specified in the Act.
Available funding is allotted in
accordance with the formula provision
of section 524 of the PHS Act.
This submission is for a revision of
the current approval of the annual
grantee reporting requirements. Section
528 of the PHS Act and the 21st Century
Cures Act specify that not later than
January 31 of each fiscal year, a funded
entity will prepare and submit a report
in such form and containing such
information as is determined necessary
for securing a record and description of
the purposes for which amounts
received under section 521 were
expended during the preceding fiscal
year and of the recipients of such
amounts and determining whether such
amounts were expended in accordance
with statutory provisions.
The proposed changes to the PATH
2020 Annual Report are as follows:
1. HMIS Data Standards updates
When needed, field response options
and questions have been updated to
align with the most recent version of the
HMIS Data Standards.
Effective October 1, 2019, the HMIS
Data Standards have been further
updated. The changes in the HMIS Data
Standards are reflected in this version of
the PATH Annual Report Manual, and
include:
—Updates to response categories for
Living Situation
—Addition of an ‘‘Unable to Locate
Client’’ response option to PATH
Status
E:\FR\FM\14MYN1.SGM
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28968
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
—Addition of a demographic question
on history with domestic violence
The estimated annual burden for
these reporting requirements is
summarized in the table below.
Number of
respondents
Respondents
Burden per
response
(hrs.)
Total burden
States ...............................................................................................................
Local provider agencies ...................................................................................
56
476
1
1
15
15
840
7,140
Total ..........................................................................................................
532
........................
........................
7,980
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.
Carlos Graham,
Social Science Analyst.
[FR Doc. 2020–10308 Filed 5–13–20; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2020–0023; OMB No.
1660–0005]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; FEMA Inspection
and Claims Forms
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
The Federal Emergency
Management Agency, 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 currently
approved information collection. In
accordance with the Paperwork
Reduction Act of 1995, this notice seeks
comments concerning the collection of
information related to the flood
insurance claims process and the
housing inspection damage assessment
process.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Responses
per
respondent
Comments must be submitted on
or before July 13, 2020.
ADDRESSES: To avoid duplicate
submissions to the docket, please use
only one of the following means to
submit comments:
DATES:
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
(1) Online. Submit comments at
www.regulations.gov under Docket ID
FEMA–2020–0023. Follow the
instructions for submitting comments.
(2) Mail. Submit written comments to
Docket Manager, Office of Chief
Counsel, DHS/FEMA, 500 C Street SW,
8NE, Washington, DC 20472–3100.
All submissions received must
include the agency name and Docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to read the
Privacy and Security Notice that is
available via a link on the homepage of
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
information related to Claims Forms,
contact: Daniel Claire, Program Analyst,
Federal Insurance & Mitigation
Administration, 202–552–9891,
Daniel.Claire@fema.dhs.gov. For
information related to Housing
Inspection Instruments, contact: Brian
Thompson, Supervisory Program
Specialist, FEMA Recovery Directorate,
Brian.Thompson6@fema.dhs.gov. You
may contact the Information
Management Division for copies of the
proposed collection of information at
email address: FEMA-InformationCollections-Management@fema.dhs.gov.
SUPPLEMENTARY INFORMATION: Congress
created the National Flood Insurance
Program (NFIP) through enactment of
the National Flood Insurance Act of
1968 (NFIA) (Title XIII of Pub. L. 90–
448, 82 Stat. 476), codified at 42 U.S.C.
4001 et seq. The NFIP is a Federal
program enabling property owners in
participating communities to purchase
insurance as a protection against flood
losses in exchange for state and
community floodplain management
requirements that reduce the risk of
future flood damages. Communities
participate in the NFIP based on an
agreement between the community and
FEMA. If a community adopts and
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Frm 00042
Fmt 4703
Sfmt 4703
enforces a floodplain management
ordinance to reduce future flood risk to
new construction in floodplains, FEMA
will make flood insurance available
within the community as a financial
protection against flood losses.
Accordingly, the NFIP is comprised of
three key activities: flood insurance,
floodplain management and flood
hazard mapping.
A prospective policyholder may
purchase an NFIP flood insurance
policy either: (1) Directly from the
Federal Government through a direct
servicing agent (referred to as ‘‘NFIP
Direct’’), or (2) from a participating
private insurance company through the
Write Your Own (WYO) Program. The
Standard Flood Insurance Policy (SFIP)
sets out the terms and conditions of
insurance. See 44 CFR part 61,
Appendix A. FEMA establishes terms,
rate structures, and premium costs of
SFIPs. The terms, coverage limits, and
flood insurance premiums are the same
whether purchased from the NFIP Direct
or the WYO Program. See 44 CFR
62.23(a).
All flood loss claims presented under
the NFIP are paid directly with U.S.
Treasury funds, regardless of whether
the policy is issued by the government
(FEMA) directly or by a WYO company.
The information in this collection
includes all the data necessary to
adjudicate claims for damages and
benefits resulting from flood losses.
In addition to the requirements of the
NFIA, section 205 of the BunningBereuter-Blumenauer Flood Insurance
Reform Act of 2004 (42 U.S.C. 4011
note) required FEMA to establish a
claims appeals process. FEMA
implemented the claim appeal process
at 44 CFR 62.20.
Pertaining to housing inspections, the
Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Stafford
Act), Pub. L. 93–288, as amended, is the
legal basis for FEMA to provide
financial assistance and services to
individuals applying for disaster
assistance benefits in the event of a
Federally-declared disaster. Regulations
in 44 CFR 206.110—Federal Assistance
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]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28967-28968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10308]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act. To request a copy of these documents, call or email the
SAMHSA Reports Clearance Officer on (240) 276-0361 or
[email protected].
Project: Projects for Assistance in Transition from Homelessness (PATH)
Program Annual Report (OMB No. 0930-0205)--Revision
The Center for Mental Health Services awards grants each fiscal
year to each of the states, the District of Columbia, the Commonwealth
of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the
Commonwealth of the Northern Mariana Islands from allotments authorized
under the PATH program established by Public Law 101-645, 42 U.S.C.
290cc-21 et seq., the Stewart B. McKinney Homeless Assistance
Amendments Act of 1990 (section 521 et seq. of the Public Health
Service (PHS) Act) and the 21st Century Cures Act (114-255 Pub. L).
Section 522 of the PHS Act and the 21st Century Cures Act requires that
the grantee states and territories must expend their payments under the
Act solely for making grants to political subdivisions of the state,
and to nonprofit private entities (including community-based veterans'
organizations and other community organizations) for the purpose of
providing services specified in the Act. Available funding is allotted
in accordance with the formula provision of section 524 of the PHS Act.
This submission is for a revision of the current approval of the
annual grantee reporting requirements. Section 528 of the PHS Act and
the 21st Century Cures Act specify that not later than January 31 of
each fiscal year, a funded entity will prepare and submit a report in
such form and containing such information as is determined necessary
for securing a record and description of the purposes for which amounts
received under section 521 were expended during the preceding fiscal
year and of the recipients of such amounts and determining whether such
amounts were expended in accordance with statutory provisions.
The proposed changes to the PATH 2020 Annual Report are as follows:
1. HMIS Data Standards updates
When needed, field response options and questions have been updated
to align with the most recent version of the HMIS Data Standards.
Effective October 1, 2019, the HMIS Data Standards have been
further updated. The changes in the HMIS Data Standards are reflected
in this version of the PATH Annual Report Manual, and include:
--Updates to response categories for Living Situation
--Addition of an ``Unable to Locate Client'' response option to PATH
Status
[[Page 28968]]
--Addition of a demographic question on history with domestic violence
The estimated annual burden for these reporting requirements is
summarized in the table below.
----------------------------------------------------------------------------------------------------------------
Burden per
Respondents Number of Responses per response Total burden
respondents respondent (hrs.)
----------------------------------------------------------------------------------------------------------------
States.......................................... 56 1 15 840
Local provider agencies......................... 476 1 15 7,140
---------------------------------------------------------------
Total....................................... 532 .............. .............. 7,980
----------------------------------------------------------------------------------------------------------------
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.
Carlos Graham,
Social Science Analyst.
[FR Doc. 2020-10308 Filed 5-13-20; 8:45 am]
BILLING CODE 4162-20-P
