Notice of Interest Rate on Overdue Debts, 22741 [2020-08564]
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Federal Register / Vol. 85, No. 79 / Thursday, April 23, 2020 / Notices
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Shruti Modi, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
2020 (85 FR 5445), FDA published a
notice with a 90-day comment period to
request comments on the document
entitled ‘‘Interpreting Sameness of Gene
Therapy Products Under the Orphan
Drug Regulations; Draft Guidance for
Industry.’’ FDA is extending the
comment period, in response to a
request from a stakeholder, until July
22, 2020. The Agency believes that a 90day extension allows adequate time for
interested persons to submit comments
without significantly delaying
publication of the final version of the
guidance.
II. Reference
The following reference is on display
in the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is also available electronically at https://
www.regulations.gov.
1. Email from Mr. Aleksandr Merenkov,
Regulatory Intelligence Specialist, Regeneron
Pharmaceuticals, Inc., to Jenifer Roe,
Regulatory Counsel, Center for Biologics
Evaluation and Research, FDA (March 26,
2020).
lotter on DSKBCFDHB2PROD with NOTICES
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: April 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08609 Filed 4–22–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Interest Rate on Overdue
Debts
Section 30.18 of the Department of
Health and Human Services’ claims
collection regulations (45 CFR part 30)
provides that the Secretary shall charge
an annual rate of interest, which is
determined and fixed by the Secretary
of the Treasury after considering private
consumer rates of interest on the date
that the Department of Health and
Human Services becomes entitled to
recovery. The rate cannot be lower than
the Department of Treasury’s current
value of funds rate or the applicable rate
determined from the ‘‘Schedule of
Certified Interest Rates with Range of
Maturities’’ unless the Secretary waives
interest in whole or part, or a different
rate is prescribed by statute, contract, or
repayment agreement. The Secretary of
the Treasury may revise this rate
quarterly. The Department of Health and
Human Services publishes this rate in
the Federal Register.
The current rate of 95⁄8%, as fixed by
the Secretary of the Treasury, is certified
for the quarter ended March 31, 2020.
This rate is based on the Interest Rates
for Specific Legislation, ‘‘National
Health Services Corps Scholarship
Program (42 U.S.C. 254o(b)(1)(A))’’ and
‘‘National Research Service Award
Program (42 U.S.C. 288(c)(4)(B)).’’ This
interest rate will be applied to overdue
debt until the Department of Health and
Human Services publishes a revision.
David C. Horn,
Director, Office of Financial Policy and
Reporting.
[FR Doc. 2020–08564 Filed 4–22–20; 8:45 am]
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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
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
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22741
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Chris Kornak at 240–627–3705 or
Chris.Kornak@nih.gov. Licensing
information may be obtained by
communicating with 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 information
related to the invention.
SUPPLEMENTARY INFORMATION:
Technology description follows:
Use of the Intracellular Signaling
Domain of Receptor CD28H as a
Component of Chimeric Antigen
Receptors To Overcome Inhibition of
Cytotoxic Lymphocytes by Checkpoint
Receptors
Description of Technology:
Engineered chimeric antigen receptors
(CARs) that are expressed in cytotoxic T
cells and natural killer (NK) cells have
been used to specifically target tumor
cells. However, CAR–T and CAR–NK
cells are still subject to downregulation
by their inhibitory receptors after
injection into patients.
Scientists at NIAID have developed
CAR constructs that overcome
inhibition of NK cells by receptors for
human major histocompatibility
complex molecules HLA–E and HLA–C,
based on in vitro studies. The CAR
contains an antigen binding domain of
receptor CD28 homolog (CD28H), a
CD28H transmembrane domain (TM), a
CD28H signaling domain, and other
intracellular signaling domains, such as
2B4 (CD244) and CD3 zeta chain
(CD3zeta). A variant of this CAR, in
which the antigen binding domain of
CD28H is replaced by a single-chain
antibody variable region (scFv) that
binds to CD19, rendered NK cells
resistant to inhibition by HLA–E and
HLA–C on CD19∂ tumor cells.
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:
• Method of adoptive therapy where
CAR–NK cell or CAR–T cell is the
effector cell.
Competitive Advantages:
• Resistant to inhibition of NK cells
or T cells by HLA–E and HLA–C.
• Manufacturing efficiency.
• CAR–NK can be developed without
the need to genetic silencing of TCR.
E:\FR\FM\23APN1.SGM
23APN1
Agencies
[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Notices]
[Page 22741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Notice of Interest Rate on Overdue Debts
Section 30.18 of the Department of Health and Human Services'
claims collection regulations (45 CFR part 30) provides that the
Secretary shall charge an annual rate of interest, which is determined
and fixed by the Secretary of the Treasury after considering private
consumer rates of interest on the date that the Department of Health
and Human Services becomes entitled to recovery. The rate cannot be
lower than the Department of Treasury's current value of funds rate or
the applicable rate determined from the ``Schedule of Certified
Interest Rates with Range of Maturities'' unless the Secretary waives
interest in whole or part, or a different rate is prescribed by
statute, contract, or repayment agreement. The Secretary of the
Treasury may revise this rate quarterly. The Department of Health and
Human Services publishes this rate in the Federal Register.
The current rate of 9\5/8\%, as fixed by the Secretary of the
Treasury, is certified for the quarter ended March 31, 2020. This rate
is based on the Interest Rates for Specific Legislation, ``National
Health Services Corps Scholarship Program (42 U.S.C. 254o(b)(1)(A))''
and ``National Research Service Award Program (42 U.S.C.
288(c)(4)(B)).'' This interest rate will be applied to overdue debt
until the Department of Health and Human Services publishes a revision.
David C. Horn,
Director, Office of Financial Policy and Reporting.
[FR Doc. 2020-08564 Filed 4-22-20; 8:45 am]
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