Agency Information Collection Activities: Submission for OMB Review; Comment Request, 42090-42091 [2023-13844]
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
pharmaceutical compositions, and
methods of use.
National Institutes of Health
Potential Commercial Applications
•
•
•
•
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Development Stage
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. to achieve
expeditious commercialization of
results of federally-funded research and
development.
FOR FURTHER INFORMATION CONTACT:
Licensing information may be obtained
by emailing the indicated licensing
contact at the National Heart, Lung, and
Blood, Office of Technology Transfer
and Development Office of Technology
Transfer, 31 Center Drive, Room 4A29,
MSC2479, Bethesda, MD 20892–2479;
Michael Shmilovich; shmilovm@
nih.gov; telephone: 301–435–5019. A
signed Confidential Disclosure
Agreement may be required to receive
any unpublished information.
SUPPLEMENTARY INFORMATION:
Technology description follows.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
Cannabinoid Receptor Modulating
Compounds
Available for licensing and
commercial development are potentially
therapeutic compounds for metabolic,
inflammatory and fibrotic disorders.
The filed patent applications includes
extensive descriptions of the exemplary
molecules and their various
constituents. The cannabinoid receptor
mediating compounds can be neutral
antagonists. A CB1 inverse agonist is a
drug that on its own produces an effect
opposite to that of a CB1 agonist, and is
also able to block the effect of a CB1
agonist. In contrast, a CB1 neutral
antagonist can only do the latter (i.e.,
blocking the effect of a CB1 agonist), but
has no effect on its own. CB1 inverse
agonism is usually documented by the
ability of a drug to decrease GTPgS
binding and/or to increase adenylate
cyclase activity. The compounds may
show functional bias for GTPgS or bArrestin or activity for both GTPgS and
b-Arrestin. Secondary targets could
include, but not limited to, the enzyme
inducible nitric oxide synthase (iNOS)
or adenosine monophosphate kinase
(AMPK), as suggested by findings that
inhibition of iNOS or activation of
AMPK improves insulin resistance, and
reduces fibrosis and inflammation. The
rights pursued claim compounds,
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17:21 Jun 28, 2023
Pharmaceuticals
Cancer therapy
Anti-fibrotic therapy
Inflammatory and autoimmune
disease
Jkt 259001
• Early stage
Inventors: Malliga R. Iyer, Ph.D.;
Pinaki Bhattacharjee, Ph.D.; Resat Cinar,
PharmD, MBA; George Kunos, M.D.,
Ph.D.; Szabolcs Dvoracsko Ph.D., (all of
NIAAA).
Intellectual Property: HHS Reference
No. E–189–2021–0; U.S. Provisional
Patent Application No. 63/319,642 filed
March 14, 2022; International Patent
Application PCT/U2023/014846 filed
March 8, 2023.
Licensing Contact: Michael
Shmilovich; 301–435–5019;
michael.shmilovich@nih.gov.
This notice is in accordance with 35
U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development.
Dated: June 23, 2023.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
[FR Doc. 2023–13792 Filed 6–28–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Clinical Trials SEP (UG3, U24).
PO 00000
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Date: July 27, 2023.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge I, 6705 Rockledge Drive, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Zhihong Shan, Ph.D., MD,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
6705 Rockledge Drive, Room 205–J,
Bethesda, MD 20892, (301) 827–7085,
zhihong.shan@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: June 26, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–13854 Filed 6–28–23; 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 (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–0361.
Project: SAMHSA Generic Clearance
for Grant Program Monitoring
Activities
To carry out OMB Circular A–102 1
and 2 CFR part 215.51,2 SAMHSA must
collect grant program information
necessary to ensure compliance with
Federal and programmatic
requirements. The Generic Clearance for
Grant Program Monitoring Activities
allows SAMHSA to collect standardized
information from its grant recipients
necessary to perform agency program
oversight activities such as monitoring
progress on recipient activities and
determining and responding to
1 Circular A–102: https://www.whitehouse.gov/
wp-content/uploads/legacy_drupal_files/omb/
circulars/A102/a102.pdf.
2 2 CFR part 215.51: https://www.govinfo.gov/
content/pkg/CFR-2012-title2-vol1/pdf/CFR-2012title2-vol1-subtitleA.pdf.
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
recipient’s training and technical
assistance (T/TA) needs. SAMHSA
currently manages grant programs that
provide prevention, treatment, recovery
support services, and T/TA for
substance use treatment and mental
health providers along the continuum of
care including prevention, harm
reduction, treatment, and recovery.
SAMHSA’s grant recipients are
currently required to submit various
types of performance reports in
accordance with their individual
program requirements. The data
collections will be designed to
standardize program monitoring and
performance reports of SAMHSA’s
grants. Program offices will use
information collected under this generic
clearance to monitor funding recipient
activities and to provide support or take
appropriate action, as needed.
A generic clearance would provide
SAMHSA’s program offices the
flexibility to create and use tailored
information collection templates based
on current program reporting
requirements. This is important to allow
for SAMHSA’s:
• Monitoring of compliance with
federal practice, guidelines, and
requirements,
• Oversight of the implementation of
the scope of the grant activities with the
grant recipients’ proposed project,
• Assessment of the efficiency and
efficacy of recipient activities,
• Quick understanding of and
remediation to national, regional, and/or
site-specific issues,
• Provision of additional support and
technical assistance, as needed,
Number of
respondents
Type of respondent
Total
responses
Hours per
response
Total annual
burden
hours
Hourly wage
cost
Total hour cost
Progress Report Template (Annual) .....................................
Progress Report (Interim) .....................................................
Grant Closeouts ....................................................................
Site Visit Report Template ....................................................
Other .....................................................................................
4,000
2,500
1,000
4,000
4,000
1
2
1
1
1
4,000
5,000
1,000
4,000
4,000
8
6
10
6
6
32,000
30,000
10,000
24,000
24,000
$26
26
26
26
26
$832,000
780,000
260,000
624,000
624,000
Total ...............................................................................
20,000
....................
28,000
....................
180,000
....................
3,120,000
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 information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2023–13844 Filed 6–28–23; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0092]
Agency Information Collection
Activities; Revision of a Currently
Approved Collection: E-Verify Program
lotter on DSK11XQN23PROD with NOTICES1
Responses
per
respondent
• Documentation of promising
practices, innovative services, and
program strengths, and
• Flexible and responsive oversight of
federal funds.
A variety of performance reports will
be used for collection. Program offices
will use information collected under
this generic clearance to monitor
funding recipient activities and to
provide support or take appropriate
action, as needed.
A variety of instruments and
platforms will be used to collect
information from respondents. The
annual burden hours requested
(180,000) are based on the number of
collections we expect to conduct over
the requested period for this clearance.
The estimated annual hour burden is
as follows:
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 60-Day notice.
AGENCY:
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) invites
SUMMARY:
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17:21 Jun 28, 2023
Jkt 259001
the general public and other Federal
agencies to comment upon this
proposed revision of a currently
approved collection of information. In
accordance with the Paperwork
Reduction Act (PRA) of 1995, the
information collection notice is
published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
burden (i.e., the time, effort, and
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until
August 28, 2023.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0092 in the body of the letter, the
agency name and Docket ID USCIS–
2007–0023. Submit comments via the
Federal eRulemaking Portal website at
https://www.regulations.gov under eDocket ID number USCIS–2007–0023.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, telephone
number (240) 721–3000 (This is not a
toll-free number. Comments are not
accepted via telephone message). Please
note contact information provided here
PO 00000
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Fmt 4703
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is solely for questions regarding this
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS website
at https://www.uscis.gov, or call the
USCIS Contact Center at 800–375–5283
(TTY 800–767–1833).
SUPPLEMENTARY INFORMATION:
Comments
You may access the information
collection instrument with instructions
or additional information by visiting the
Federal eRulemaking Portal site at:
https://www.regulations.gov and
entering USCIS–2007–0023 in the
search box. 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
consider limiting the amount of
personal information that you provide
in any voluntary submission you make
to DHS. DHS may withhold information
provided in comments from public
viewing that it determines may impact
the privacy of an individual or is
offensive. For additional information,
please read the Privacy Act notice that
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]]>Agencies
[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42090-42091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13844]
-----------------------------------------------------------------------
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 (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-0361.
Project: SAMHSA Generic Clearance for Grant Program Monitoring
Activities
To carry out OMB Circular A-102 \1\ and 2 CFR part 215.51,\2\
SAMHSA must collect grant program information necessary to ensure
compliance with Federal and programmatic requirements. The Generic
Clearance for Grant Program Monitoring Activities allows SAMHSA to
collect standardized information from its grant recipients necessary to
perform agency program oversight activities such as monitoring progress
on recipient activities and determining and responding to
[[Page 42091]]
recipient's training and technical assistance (T/TA) needs. SAMHSA
currently manages grant programs that provide prevention, treatment,
recovery support services, and T/TA for substance use treatment and
mental health providers along the continuum of care including
prevention, harm reduction, treatment, and recovery.
---------------------------------------------------------------------------
\1\ Circular A-102: https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A102/a102.pdf.
\2\ 2 CFR part 215.51: https://www.govinfo.gov/content/pkg/CFR-2012-title2-vol1/pdf/CFR-2012-title2-vol1-subtitleA.pdf.
---------------------------------------------------------------------------
SAMHSA's grant recipients are currently required to submit various
types of performance reports in accordance with their individual
program requirements. The data collections will be designed to
standardize program monitoring and performance reports of SAMHSA's
grants. Program offices will use information collected under this
generic clearance to monitor funding recipient activities and to
provide support or take appropriate action, as needed.
A generic clearance would provide SAMHSA's program offices the
flexibility to create and use tailored information collection templates
based on current program reporting requirements. This is important to
allow for SAMHSA's:
Monitoring of compliance with federal practice,
guidelines, and requirements,
Oversight of the implementation of the scope of the grant
activities with the grant recipients' proposed project,
Assessment of the efficiency and efficacy of recipient
activities,
Quick understanding of and remediation to national,
regional, and/or site-specific issues,
Provision of additional support and technical assistance,
as needed,
Documentation of promising practices, innovative services,
and program strengths, and
Flexible and responsive oversight of federal funds.
A variety of performance reports will be used for collection.
Program offices will use information collected under this generic
clearance to monitor funding recipient activities and to provide
support or take appropriate action, as needed.
A variety of instruments and platforms will be used to collect
information from respondents. The annual burden hours requested
(180,000) are based on the number of collections we expect to conduct
over the requested period for this clearance.
The estimated annual hour burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Responses Total Hours per annual Hourly wage Total hour
Type of respondent respondents per responses response burden cost cost
respondent hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Progress Report Template (Annual)......................... 4,000 1 4,000 8 32,000 $26 $832,000
Progress Report (Interim)................................. 2,500 2 5,000 6 30,000 26 780,000
Grant Closeouts........................................... 1,000 1 1,000 10 10,000 26 260,000
Site Visit Report Template................................ 4,000 1 4,000 6 24,000 26 624,000
Other..................................................... 4,000 1 4,000 6 24,000 26 624,000
---------------------------------------------------------------------------------------------
Total................................................. 20,000 ........... 28,000 ........... 180,000 ........... 3,120,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 information collection
by selecting ``Currently under 30-day Review--Open for Public
Comments'' or by using the search function.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2023-13844 Filed 6-28-23; 8:45 am]
BILLING CODE 4162-20-P
