Lewis-Burke Health Highlights
A Weekly Dose of Federal Highlights Impacting Academic Medicine and Health Professions 

June 4, 2021

Table of Contents

Non-NIH Grants

Biden Administration Releases FY 2022 Budget Request for HHS
The Biden Administration’s budget request would provide $131.8 billion in discretionary funding and $1.5 trillion in mandatory funding for activities at the Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and other programs.  The budget request would invest in initiatives to bolster pandemic preparedness and response efforts, address mental health and substance use disorders, mitigate health inequities, and tackle community violence.  New priorities include efforts to bolster the nation’s public health infrastructure and workforce, expand activities across the agency to help eliminate health disparities and promote cultural competency, and enhance support for research and interventions to reduce violence across the nation’s communities.

Signature initiatives include:

• strengthening public health preparedness and response;
• addressing health inequities;
• promoting injury prevention control;
• increasing access to healthcare;
• calling on Congress to expand Medicare; and
• expanding home and community-based services.

Ongoing areas of interest for the Administration include tackling mental health and substance use disorders; strengthening rural health; improving maternal health; and supporting early childhood development.

For the NIH, within HHS, the request would provide $52 billion in FY 2022, an increase of $9 billion, or 21 percent, above the FY 2021 enacted level.  Of this amount, $6.5 billion is included to establish the Advanced Research Projects Agency for Health (ARPA-H), a new entity that would aim to “drive transformational health research innovation and speed medical breakthroughs.”

If established, ARPA-H has the potential to reshape the nation’s biomedical research enterprise.  In addition, the Biden Administration would invest in new research priorities related to the impacts of climate change on human health and research to eliminate health disparities and improve health equity.
 
Lewis-Burke’s full analysis of the budget request can be found here.

HHS Launches Partnership with the Global Health Investment Corporation to Combat Future Pandemics
The Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority’s (BARDA) Ventures program, will be partnering with the Global Health Investment Corporation (GHIC) in an effort to develop and commercialize medical products needed to respond to or prevent public health emergencies, such as pandemics, and other health security threats.

The partnership with GHIC will be supported through BARDA’s Division of Research, Innovation, and Ventures (DRIVe). DRIVe was established in 2018 to focus on breakthrough technologies and capabilities needed to address health security threats, and often works with universities to get new technologies to market.  According to HHS, BARDA will provide GHIC a minimum of $50 million over five years, with the potential for up to $500 million over 10 years.  GHIC will in turn, launch a global health security fund with matching capital from the investment community.  As the technologies generate investment returns, proceeds from BARDA Ventures funding will be returned to GHIC for reinvestment, and to sustain BARDA Ventures.  This partnership model was developed after BARDA drew on responses from two public requests for information and discussions with venture capital experts in the government and private sector.  GHIC was selected because of their successful track record of venture capital investments in healthcare and the life sciences.

Congressional Democrats Announce Bill to Permanently Authorize and Expand the Teaching Health Center Graduate Medical Education Program
House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) announced legislation to permanently authorize the Teaching Center Graduate Medical Education (THCGME) program.  The THCGME program supports the training of primary care medical and dental residents with a focus on supporting residents in high-need communities.  Chairman Pallone recently introduced the legislation in the House of Representatives, with the Senate planning on introducing the legislation next week.

The legislation, titled the Doctors of Community (DOC) Act, amends the Public Health Service Act by permanently authorizing the THCGME program through providing sustained annual funding at over $500 million per year for fiscal years 2024-2033, and increases the number of residency slots available each year.  The THCGME program is currently funded at $126.5 million per year.  If enacted the bill would provide funding for an additional 100 new THCGME programs and create an estimated 1,600 new resident physician slots.

Full bill text is available here and a bill one-pager is available here.

NIEHS Advisory Council Discusses Opportunities for Cross-Disciplinary Collaboration at Spring Meeting
The National Advisory Environmental Health Sciences Council, which provides guidance and counsel to the National Institute of Environmental Health Sciences (NIEHS) at the National Institutes of Health (NIH), met for the second time this year on June 1 and 2.  While no concept clearances for new programs were presented at this meeting, the agenda featured several scientific talks on the role of the exposome in shaping human health as well as broad discussion of opportunities for NIEHS to collaborate with other NIH Institutes and Centers (ICs) as well as other federal funding agencies.

In his report to the advisory council, NIEHS Director Rick Woychik highlighted several relevant items of interest from President Biden’s recently released budget request for fiscal year (FY) 2022, including a proposed increase of $100 million to the Climate Change and Human Health program at NIH and the formation of an Office of Climate Change and Health Equity within the Department of Health and Human Services.  Dr. Woychik noted that NIEHS is leading a coalition of eleven other ICs to support expanded research programs on climate health, and listed NIH’s priorities in this area as:

• Building a multidisciplinary research workforce;
• Developing state-of-the-art data infrastructure;
• Supporting sustained research partnerships with disadvantaged communities;
• Building rapid disaster research response capacity; and
• Supporting innovative discovery and solutions-based research to better understand environmental influences on human health, potential “surprises” from climate-related disruptions, and the health and economic benefits of climate actions.

Mirroring Dr. Woychik’s appearances at other IC advisory council meetings this spring to discuss collaboration opportunities with NIEHS, this meeting featured a presentation from National Institute of Neurological Disorders and Stroke (NINDS) Director Walter Koroshetz.  Dr. Koroshetz concurred with Dr. Woychik’s views on the value of collaboration in environmental health, and spoke about how NINDS’ basic, translational, and clinical expertise could be useful in examining the nervous system-blood interface, as well as other body-environmental interfaces.
 

Non-NIH Grants OPPORTUNITY NUMBER OPPORTUNITY TITLE AGENCY NAME CLOSE DATE         CMS-1W1-21-002 Minority Research Grant Program Centers for Medicare & Medicaid Services 6/11/2021 PA-17-007 Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18) Agency for Health Care Research and Quality 6/15/2021 HRSA-21-050 Maternal, Infant, and Early Childhood Home Visiting Program – Formula Health Resources and Services Administration 6/15/2021 PA-18-794 AHRQ Small Research Grant Program (R03) Agency for Health Care Research and Quality 7/5/2021 PA-18-795 AHRQ Health Services Research Projects (R01) Agency for Health Care Research and Quality 7/5/2021 PA-17-008 Large Research Projects for Prevention of Healthcare-Associated Infections (R01) Agency for Health Care Research and Quality 7/6/2021 PA-17-246 Health Information Technology (IT) to Improve Health Care Quality and Outcomes (R21) Agency for Health Care Research and Quality 7/16/2021 PA-18-750 Making Health care Safer in Ambulatory Care Settings and Long Term Care Facilities (R18) Agency for Health Care Research and Quality 9/7/2021 HHS-2021-ACL-AOA-DASG-0002 Disaster Assistance for State Units on Aging (SUAs) and Tribal Organizations in Major Disasters Declared by the President Administration for Community Living 9/7/2021 NAP-AX-18-003 Leading Edge Acceleration Projects (LEAP) in Health Information Technology Office of the National Coordinator 9/30/2021 RFA-FD-21-001 Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Food and Drug Administration 10/5/2021 PA-16-422 Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB)(R18) Agency for Health Care Research and Quality 10/30/2021 PA-16-423 Large Research Projects for Combating  Antibiotic-Resistant Bacteria (CARB) (R01) Agency for Health Care Research and Quality 10/30/2021 PA-16-453 AHRQ Conference Grant Programs (R13) Agency for Health Care Research and Quality 11/1/2021 RFA-FD-18-001 Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U18) Food and Drug Administration 12/1/2021 PA-20-074 Disseminating and Implementing Patient-Centered Outcomes Research (PCOR) Evidence into Practice through Interoperable Clinical Decision Support Agency for Health Care Research and Quality 1/25/2022 PAR-20-083 Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional Food and Drug Administration 4/4/2022 PAR-20-105 Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed Food and Drug Administration 4/6/2022 PAR-20-124 NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens (U01) Clinical Trials Not Allowed Food and Drug Administration 5/2/2022 PA-21-202 AHRQ/PCORI Learning Health System Small Grant Pilot Program Agency for Health Care Research and Quality 6/16/2022 PA-17-232 AHRQ Mentored Clinical Scientist Research Career Development Award (K08) Agency for Health Care Research and Quality 7/12/2022 PA-17-481 Agency for Healthcare Research and Quality (AHRQ)-sponsored National Research Service Award (NRSA)Individual  Postdoctoral Fellowship (F32) Agency for Health Care Research and Quality 8/8/2022 PA-20-028 Medication Safety:  Advancing the Development of Improvement Strategies and Tools (R18) Agency for Health Care Research and Quality 9/25/2022 PA-18-793 AHRQ Health Services Research Demonstration and Dissemination Grants (R18) Agency for Health Care Research and Quality 9/29/2022 PAR-19-306 FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Food and Drug Administration 10/11/2022 PA-20-067 AHRQ Mentored Research Scientist  Career Development Award (K01) Agency for Health Care Research and Quality 11/13/2022 PA-20-068 Improving Quality of Care and Patient Outcomes During Care Transitions (R01) Agency for Health Care Research and Quality 12/6/2022 PA-18-765 AHRQ Health Services Research Dissertation Program (R36) Agency for Health Care Research and Quality 5/1/2023 PAR-21-178 Drug Development Tools Research Grants (U01) Clinical Trial Optional Food and Drug Administration 5/3/2023 PAR-18-604 Vet-LIRN Network Capacity-Building Projects Food and Drug Administration 9/2/2023 PAR-21-179 Minor Use Minor Species Development of Drugs (R01) Food and Drug Administration 2/3/2024 PA-21-164 Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional) Agency for Health Care Research and Quality 7/17/2024