Notice2025-23245
Notice of Award of a Single Source Unsolicited Grant To Fund University of Southern Denmark (SDU)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 18, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,600,000 over a five-year period, in response to an unsolicited proposal that has been submitted by University of Southern Denmark (SDU). The award will support a comparable study of the optimal timing and delivery of monovalent Hepatitis B vaccinations on newborns in Guinea-Bissau. Activities will include conducting a randomized controlled trial to assess the effects of neonatal Hepatitis B vaccination on early-life mortality, morbidity, and long-term developmental outcomes. The award is in response to an unsolicited proposal.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 241 (Thursday, December 18, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 241 (Thursday, December 18, 2025)]
[Notices]
[Pages 59124-59125]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23245]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Award of a Single Source Unsolicited Grant To Fund
University of Southern Denmark (SDU)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces the
award of approximately $1,600,000 over a five-year period, in response
to an unsolicited proposal that has been submitted by University of
Southern Denmark (SDU). The award will support a comparable study of
the optimal timing and delivery of monovalent Hepatitis B vaccinations
on newborns in Guinea-Bissau. Activities will include conducting a
randomized controlled trial to assess the effects of neonatal Hepatitis
B vaccination on early-life mortality, morbidity, and long-term
developmental outcomes. The award is in response to an unsolicited
proposal.
DATES: The period for this award will be January 5, 2026, through
January 4, 2031.
FOR FURTHER INFORMATION CONTACT: Sam Beyda, Office of the Director,
Office of the Chief of Staff, Centers for Disease Control and
Prevention, 4770 Buford Highway NE, Atlanta, GA 30341, Telephone: (404)
404-639-7000, E-Mail: <a href="/cdn-cgi/l/email-protection#e9ad809b8c8a9d869b9aa0878a868480878ea98a8d8ac78e869f"><span class="__cf_email__" data-cfemail="2b6f42594e485f445958624548444642454c6b484f48054c445d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The proposed work being funded will support
a single-blind, multi-center, phase IV randomized controlled trial
enrolling over 14,000 neonates in Guinea-Bissau to evaluate the impact
of neonatal monovalent Hepatitis B vaccination (HBV0) on all-cause
mortality, severe morbidity, and long-term developmental outcomes. The
study will also assess potential sex-differential effects of the
vaccine. While the World Health Organization (WHO) recommends three
vaccines at birth in low-income settings--Bacille Calmette
Gu[eacute]rin (BCG), oral polio vaccine (OPV0), and HBV0--there is
limited evidence on the broader health effects of HBV0. This study aims
to fill that gap by rigorously evaluating the overall health impact of
HBV0 in early life.
CDC performed an objective review of the proposed work and
determined, in accordance with its process for reviewing unsolicited
proposals that the
[[Page 59125]]
proposal has merit and that SDU is in a unique position to conduct this
work, as it has extensive experience conducting vaccine trials in West
Africa, established partnerships with local hospitals and health
authorities in Guinea-Bissau, and a proven track record in neonatal and
pediatric research in low-resource settings.
The award is being made non-competitively because there is no
current, pending, or planned funding opportunity announcement under
which this proposal could compete.
Summary of the Award
Recipient: University of Southern Denmark (SDU).
Purpose of the Award: The purpose of this award is to evaluate the
effects of neonatal monovalent Hepatitis B vaccination (HBV0) on early-
life mortality and morbidity, as well as long-term neurodevelopmental
outcomes, through a randomized controlled trial in Guinea-Bissau. The
findings will inform global immunization policy and practice,
particularly regarding the broader health effects of HBV0, which remain
less well understood compared to BCG and OPV0.
Amount of Award: $1,600,000 in Federal Fiscal Year (FFY) 2026
funds, with the total estimated $1,600,000 provided for the full five-
year period of performance, subject to availability of funds.
Authority: This program is authorized under the Public Health
Service Act, Sections 301(a) [42 U.S.C. 241], 307 (42 U.S.C. 242l], and
317(k)(2) [42 U.S.C. 247b], as amended.
Period of Performance: January 5, 2026, through January 4, 2031.
Dated: December 15, 2025.
Jamie Legier,
Chief Grants Management Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2025-23245 Filed 12-17-25; 8:45 am]
BILLING CODE 4163-18-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 18, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.