Government-Owned Materials; Availability for Access, 99267-99268 [2024-28924]
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Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
99267
DETAILED INCLUSION AND EXCLUSION CRITERIA FOR SYSTEMATIC REVIEW—Continued
Category
Outcomes .................
Timing .......................
Setting ......................
Study Designs, Publication Types, and
Language.
Include
Exclude
KQ 3, 3a, 3b, 4, 4a, 4b: Eligible followup imaging for routine surveillance of kidney stones, no followup imaging.
All KQs: Patient-centered health outcomes: Incident symptomatic stones, urinary tract obstruction with acute renal
impairment, end-stage renal disease, urinary tract infection, stone-removal procedures/surgery, procedure-related morbidity, emergency department visits and hospitalizations, quality of life, missed school or work, preventive treatment-related adverse events, imaging-related adverse events, serious adverse events,
discontinuations due to adverse events.
Intermediate outcomes: Growth of existing stones, incident
radiographic stones, radiation exposure, incidental imaging findings.
KQ 1, 3: Studies that measure outcomes at least 12
months after baseline.
KQ 2, 4: Followup not limited.
Outpatient clinical settings including primary care, urology,
nephrology, or other specialty stone clinics; countries
with HDI12 of very high (Appendix B).
All KQs: Published in peer-reviewed literature, unpublished
studies with enough information about methods to determine risk of bias; English language. RCTs; for comparisons lacking sufficient RCT evidence, NRSIs with concurrent comparator group and primary study aim/outcome to assess a dietary or pharmacologic intervention
or surveillance imaging approach are eligible.
KQ 1, 1a, 1b, 3, 3a, 3b: Blood or urine chemistry measures, urine supersaturation measures, acute pain.
KQ 1, 3: Studies of less than 12-months duration.
Inpatient settings; Countries with HDI other than very high.
All KQs: Interrupted time series, case series, narrative reviews, editorials, and commentaries are not eligible; systematic reviews are not eligible but will be reviewed to
determine whether any included studies are eligible.
Studies with fewer than 30 participants at baseline per
study arm. Studies published in languages other than
English.
KQ 2: Studies designed to report epidemiologic associations between dietary factors and stone incidence.
CT = computed tomography; FDA = U.S. Food and Drug Administration; HDI = United Nations Development Programme Human Development
Index; KQ = key question; NRSI = nonrandomized study of intervention; OTC = over-the-counter; RCT = randomized controlled trial.
Dated: December 4, 2024.
Marquita Cullom,
Associate Director.
SUPPLEMENTARY INFORMATION:
Royalty-Free Starting Material (MVAclone 1) for the Clinical Development,
Evaluation, and Commercialization of a
Viable Mpox Vaccine
[FR Doc. 2024–28933 Filed 12–9–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Materials;
Availability for Access
National Institute of Allergy
and Infectious Diseases, National
Institutes of Health, HHS.
ACTION: Notice.
AGENCY:
The material listed below is
owned by an agency of the U.S.
Government and is available for transfer
to achieve expeditious use and/or
commercialization of results of federally
funded research and development.
FOR FURTHER INFORMATION CONTACT:
Access 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 by contacting
Benjamin Hurley at 240–669–5092 or
benjamin.hurley@nih.gov.
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
Worldwide, leading health authorities
have cited the growing need for a
commitment to equitable vaccine access
and its role in curtailing future
epidemics—a vision that cannot be
realized without significant
improvements in the speed, scale, and
access of vaccine manufacturing and
deployment in historically underserved
regions. For at-risk populations and
those with contraindications to
commonly deployed vaccines, such
initiatives are even more vital.
Modified vaccinia virus Ankara
(MVA), developed more than 30 years
ago as a highly attenuated candidate
smallpox vaccine, was recloned at the
U.S. National Institute of Allergy and
Infectious Diseases (NIAID) (referred to
here as ‘‘MVA clone-1’’) from a 1974originating passage and evaluated for
safety and immunogenicity in both
normal and partially immune-deficient
animals. Subsequent studies verified the
protective ability of this attenuated
vaccine against mpox in non-human
primates, and clinical efforts since have
resulted in FDA approval and
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
availability of a two-dose MVA vaccine
in the U.S.
In support of the global humanitarian
effort to achieve equitable vaccine
access and in light of the current public
health emergency of international
concern (PHEIC) declared by the World
Health Organization in 2024—which
has resulted in more than 500 deaths in
the Democratic Republic of the Congo
since the beginning of this year—the
National Institute of Allergy and
Infectious Diseases (NIAID) is seeking
inquiries from parties interested in
independent R&D and/or collaborative
research to further develop, evaluate,
and commercialize a viable mpox
vaccine for distribution (particularly in
developing nations/regions currently
having minimal access to mpox
vaccines) using NIH-provided starting
material (MVA clone-1). While
traditional licensing opportunities
related to mpox detection are also
available (e.g., antibodies, neutralization
assays), NIAID will transfer the MVA
clone-1 material in question on a
royalty-free basis to qualified partners in
an effort to combat the current PHEIC.
In the event that NIAID has limited
ability to distribute material, or if
supply approaches exhaustion, priority
will be given to collaborators with a
proposed plan demonstrating, in
E:\FR\FM\10DEN1.SGM
10DEN1
khammond on DSK9W7S144PROD with NOTICES
99268
Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
NIAID’s sole judgment, the ability to
develop a viable vaccine. Potential
collaborators considered equally
competitive in terms of capacity will
also be evaluated based on their plans
and intent to distribute in areas with
immediate need, followed by the
likelihood of the proposed plan
contributing to the achievement of a
self-sustaining vaccine ecosystem in
developing nations.
This material is available for access
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 agreement.
Potential Commercial Applications:
• Prophylaxis against mpox in normal
or high-risk populations
• Vaccine research
Competitive Advantages:
• MVA clone-1 material is believed to
be functionally and genetically
similar to FDA-approved vaccine
material
• Identification of vaccine candidates
that can elicit protective antibodies
against mpox in normal or high-risk
populations
• Royalty-free access for vaccine
development and/or research
Development Stage:
• Pre-clinical
NIH Contributor: Bernard Moss, MD,
Ph.D.
Publications:
• Earl PL, et al. (2004)
Immunogenicity of a highly attenuated
MVA smallpox vaccine and protection
against monkeypox. Nature. 428:182.
• Wyatt LS, et al. (2004) Highly
attenuated smallpox vaccine protects
mice with and without immune
deficiencies against pathogenic vaccinia
virus challenge. Proc Nat Acad Sci
USA.101:4590.
• Earl PL, et al. (2003) Development
and use of a vaccinia virus
neutralization assay based on flow
cytometric detection of green
fluorescent protein. J Virol. 77:10684.
Intellectual Property: N/A.
Technology Transfer Specialist: To
discuss access to this technology, please
contact Benjamin Hurley at
(benjamin.hurley@nih.gov).
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking inquiries
from parties interested in independent
R&D and/or collaborative research to
further develop, evaluate, and
commercialize a viable mpox vaccine
for distribution using this material.
Please contact Benjamin Hurley at 240–
669–5092 or benjamin.hurley@nih.gov.
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
Dated: December 4, 2024.
Jeremiah D. Mitzelfelt,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2024–28924 Filed 12–9–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[LLHQ430000.L12200000.PM0000; OMB
Control No. 1004–0217]
Agency Information Collection
Activities; Submission to the Office of
Management and Budget for Review
and Approval; Surveys and Focus
Groups To Support OutcomesFocused Management (Recreation
Survey and Focus Groups)
Bureau of Land Management,
Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995
(PRA), the Bureau of Land Management
(BLM) has submitted an information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review.
DATES: Interested persons are invited to
submit comments on or before January
9, 2025.
ADDRESSES: 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.
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact Matt Blocker, Outdoor
Recreation Planner, by email at
mblocker@blm.gov, or by telephone at
(385) 341–3403. Individuals who are
hearing or speech impaired may call the
Federal Relay Service at 1–800–877–
8339 for TTY assistance. You may also
view the ICR at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION: In
accordance with the PRA (44 U.S.C.
3501 et seq.) and 5 CFR 1320.8(d)(1)),
we provide the general public and other
Federal agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
A Federal Register notice with a 60day public comment period soliciting
comments on this collection of
information was published on July 5,
2024 (89 FR 55653). No comments were
received.
As part of our continuing effort to
reduce paperwork and respondent
burdens, we are again soliciting
comments from the public and other
Federal agencies on the proposed ICR
that is described below. We are
especially interested in public comment
addressing the following:
(1) Whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) The accuracy of our estimate of the
burden for this collection of
information, including the validity of
the methodology and assumptions used;
(3) Ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) How might the agency minimize
the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of response.
Comments that you submit in
response to this notice are a matter of
public record. Before including your
address, phone number, email address,
or other personal identifying
information in your comment, you
should be aware that your entire
comment—including your personal
identifying information—may be made
publicly available at any time. While
you can ask us in your comment to
withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Abstract: Information will be
collected from visitors of public lands
and community members near public
lands. Information gathered from
visitors and local community residents
will be used to inform planning
decisions in support of BLM’s Planning
for Recreation and Visitor Services
Handbook H–8320–1. This request is for
OMB to renew these surveys and focus
groups for three (3) years.
Title of Collection: Surveys and Focus
Groups to Support Outcomes-Focused
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 89, Number 237 (Tuesday, December 10, 2024)]
[Notices]
[Pages 99267-99268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Materials; Availability for Access
AGENCY: National Institute of Allergy and Infectious Diseases, National
Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The material listed below is owned by an agency of the U.S.
Government and is available for transfer to achieve expeditious use
and/or commercialization of results of federally funded research and
development.
FOR FURTHER INFORMATION CONTACT: Access 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 by contacting Benjamin Hurley at 240-
669-5092 or [email protected].
SUPPLEMENTARY INFORMATION:
Royalty-Free Starting Material (MVA-clone 1) for the Clinical
Development, Evaluation, and Commercialization of a Viable Mpox Vaccine
Worldwide, leading health authorities have cited the growing need
for a commitment to equitable vaccine access and its role in curtailing
future epidemics--a vision that cannot be realized without significant
improvements in the speed, scale, and access of vaccine manufacturing
and deployment in historically underserved regions. For at-risk
populations and those with contraindications to commonly deployed
vaccines, such initiatives are even more vital.
Modified vaccinia virus Ankara (MVA), developed more than 30 years
ago as a highly attenuated candidate smallpox vaccine, was recloned at
the U.S. National Institute of Allergy and Infectious Diseases (NIAID)
(referred to here as ``MVA clone-1'') from a 1974-originating passage
and evaluated for safety and immunogenicity in both normal and
partially immune-deficient animals. Subsequent studies verified the
protective ability of this attenuated vaccine against mpox in non-human
primates, and clinical efforts since have resulted in FDA approval and
availability of a two-dose MVA vaccine in the U.S.
In support of the global humanitarian effort to achieve equitable
vaccine access and in light of the current public health emergency of
international concern (PHEIC) declared by the World Health Organization
in 2024--which has resulted in more than 500 deaths in the Democratic
Republic of the Congo since the beginning of this year--the National
Institute of Allergy and Infectious Diseases (NIAID) is seeking
inquiries from parties interested in independent R&D and/or
collaborative research to further develop, evaluate, and commercialize
a viable mpox vaccine for distribution (particularly in developing
nations/regions currently having minimal access to mpox vaccines) using
NIH-provided starting material (MVA clone-1). While traditional
licensing opportunities related to mpox detection are also available
(e.g., antibodies, neutralization assays), NIAID will transfer the MVA
clone-1 material in question on a royalty-free basis to qualified
partners in an effort to combat the current PHEIC. In the event that
NIAID has limited ability to distribute material, or if supply
approaches exhaustion, priority will be given to collaborators with a
proposed plan demonstrating, in
[[Page 99268]]
NIAID's sole judgment, the ability to develop a viable vaccine.
Potential collaborators considered equally competitive in terms of
capacity will also be evaluated based on their plans and intent to
distribute in areas with immediate need, followed by the likelihood of
the proposed plan contributing to the achievement of a self-sustaining
vaccine ecosystem in developing nations.
This material is available for access 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
agreement.
Potential Commercial Applications:
Prophylaxis against mpox in normal or high-risk populations
Vaccine research
Competitive Advantages:
MVA clone-1 material is believed to be functionally and
genetically similar to FDA-approved vaccine material
Identification of vaccine candidates that can elicit
protective antibodies against mpox in normal or high-risk populations
Royalty-free access for vaccine development and/or research
Development Stage:
Pre-clinical
NIH Contributor: Bernard Moss, MD, Ph.D.
Publications:
Earl PL, et al. (2004) Immunogenicity of a highly
attenuated MVA smallpox vaccine and protection against monkeypox.
Nature. 428:182.
Wyatt LS, et al. (2004) Highly attenuated smallpox vaccine
protects mice with and without immune deficiencies against pathogenic
vaccinia virus challenge. Proc Nat Acad Sci USA.101:4590.
Earl PL, et al. (2003) Development and use of a vaccinia
virus neutralization assay based on flow cytometric detection of green
fluorescent protein. J Virol. 77:10684.
Intellectual Property: N/A.
Technology Transfer Specialist: To discuss access to this
technology, please contact Benjamin Hurley at
([email protected]).
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking inquiries from parties
interested in independent R&D and/or collaborative research to further
develop, evaluate, and commercialize a viable mpox vaccine for
distribution using this material. Please contact Benjamin Hurley at
240-669-5092 or [email protected].
Dated: December 4, 2024.
Jeremiah D. Mitzelfelt,
Acting Deputy Director, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-28924 Filed 12-9-24; 8:45 am]
BILLING CODE 4140-01-P
