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

October 8, 2021

Table of Contents

Council on Combating Antibiotic-Resistant Bacteria Approves Recommendations to HHS

OSTP Releases ARPA-H Listening Sessions Summary Report

NIH Director Francis Collins Announces Decision to Resign at the End of Year

New Provider Relief Fund Application Portal Open

HHS Study Reveals Vaccinations Protected Vulnerable Seniors

New Study Finds One out of Five Hundred Children Lost a Primary Caregiver During the Pandemic

Non-NIH Grants

Council on Combating Antibiotic-Resistant Bacteria Approves Recommendations to HHS 
The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) discussed and voted to approve a letter to the Secretary of Health and Human Services (HHS) containing recommendations on antimicrobial development incentive legislation.  The purpose of this council is to provide recommendations to improve programs and policies concerning antibiotic resistance, particularly using a One Health approach.  Committee Chair Martin Blaser of Rutgers University began the meeting with a presentation outlining specific current challenges of antibiotic resistance, potential solutions, and the recommendations put forth in the letter. 

The PACCARB states one of the biggest challenges to addressing antibiotic resistance is insufficient investment from private companies in developing new antimicrobial drugs due to the higher cost of drug development compared to sales revenue of existing products.  Additionally, payment structures and antibiotic prescription guidelines tend to push hospitals and physicians to prescribe less costly, older drugs rather than newer, more expensive ones, further reducing revenue for more newly-developed therapies.  The PACCARB expressed support for two pieces of legislation that seek to resolve these issues: the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act and the Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act.  The DISARM Act would change the hospital payment system to incentivize use of newer antimicrobial drugs by providing payment for certain drugs outside of the diagnosis-related group (DRG) payment system, which currently provides hospitals with a flat rate payment for treating a condition regardless of the cost, often leading physicians to use the least expensive treatment methods.  The PASTEUR Act would create a modified payment system for new antimicrobial drugs to address the reduced revenue.  This bill would authorize HHS to enter into a subscription purchasing contract for critical-need antimicrobial drugs, incentivizing investment in research and development and reducing the risk to companies that wish to develop new drugs.  The letter also expressed the importance of stewardship incentives in both bills to promote responsible use of antimicrobial drugs, including stewardship grant programs and antimicrobial use and resistance reporting.   

OSTP Releases ARPA-H Listening Sessions Summary Report  
The White House Office of Science and Technology Policy (OSTP) released a report summarizing recommendations and findings from a series of fifteen listening sessions held this summer by OSTP and the National Institutes of Health (NIH) regarding the proposed Advanced Research Projects Agency for Health (ARPA-H).  ARPA-H, the Biden Administration’s signature biomedical research policy initiative, would use nontraditional approaches to “drive transformational health research innovation and speed medical breakthroughs.”  The observations generated by the listening sessions will be used by policymakers in Congress and the Executive Branch to help shape ARPA-H’s scale, scope, and approach. 

Most of the listening sessions focused on a specific research area such as cancer, genomics, and translational research, among others.  Other invitation-only sessions provided a space for stakeholder organizations and advocacy groups to provide feedback regarding the potential structure and scope of an ARPA-H.  Based on stakeholder feedback, several areas of possible scientific emphasis for ARPA-H were highlighted in the report including: 

• Focusing on technologies that address a wide array of diseases to ensure positive patient outcomes, such as artificial intelligence, machine-learning algorithms, and wearable digital technologies; 
• Developing and implementing data sharing platforms, including the integration of electronic health record (EHR) systems, to allow for more interdisciplinary research approaches; 
• Centering early detection, diagnostic, and treatment platforms as opposed to focusing on disease-driven outcomes; and 
• Ensuring research activities complement and do not compete with NIH’s research portfolio or the private sector. 

Listening session participants also highlighted the significant role that diversity and equity should play in the overall mission of ARPA-H, not only as it pertains to agency leadership and program managers, but also in proposal reviews and award stages, and participant recruitment in clinical trials.  Participants also emphasized the need for ARPA-H to establish diverse multi-sector partnerships and collaborations with federal agencies, pharmaceutical companies and other industries, academic institutions, and non-governmental entities, among others.  In particular, partnerships with the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) will be essential in establishing stable manufacturing supply chains, promoting insurance reimbursement for new technologies and therapeutics, and enabling wide-scale distribution of novel treatments and technologies.   

OSTP and NIH will be holding another ARPA-H Listening and Feedback Session on October 20, 2021 from 2:30 – 4:00 pm. To submit public comments regarding ARPA-H, please send them to ARPAHcomments@nih.gov.  Registration information for the upcoming listening session can be found here.  
 

NIH Director Francis Collins Announces Decision to Resign at the End of Year 
Dr. Francis Collins, Director of the National Institutes of Health (NIH), announced that he will step down from his position by the end of the year.  Dr. Collins led the agency for 12 years, over the course of three Presidential Administrations, longer than any previous NIH Director.  During his tenure, Dr. Collins was well-liked by Congress and worked with both political parties to increase funding for NIH.  Following his resignation, Dr. Collins will return to his research laboratory at the National Human Genome Research Institute and continue his research to understand the causes of and ways to prevent type 2 diabetes.  

This departure comes at a very critical time for NIH, due to the heightened importance of NIH research during the COVID-19 pandemic and the proposal to create the Advanced Research Projects Agency for Health (ARPA-H) within NIH.  At this time, there are no names circulating for who could be the next NIH Director.  It is likely that Principal Deputy Director Larry Tabak will become the Acting Director while the White House begins its search for a permanent Director.  The Biden Administration now must fill two senior health official positions: NIH Director and Food and Drug Administration (FDA) Commissioner.  President Biden’s statement on the resignation of Dr. Collins can be found here.  

New Provider Relief Fund Application Portal Open
The new COVID-19 Provider Relief Fund (PRF) Application Portal is open for healthcare providers.  The portal will be used for applicants to access over $25 billion in provider relief funds under the American Rescue Plan (ARP), including $8.5 billion in funding for rural patients covered by Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), and $17 billon in “Phase 4” funds for a broader range of providers.  Providers can apply for both programs under a single application.  Applications are due Tuesday, October 26.  The Health Resources and Services Administration (HRSA) will also host technical assistance webinars for applicants on October 13 and October 21. 
  
HHS Study Reveals Vaccinations Protected Vulnerable Seniors  
According to a study by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) at the Department of Health and Human Services (HHS), vaccination among Medicare beneficiaries reduced infections, hospitalizations, and deaths from January to May 2021.  HHS believes COVID-19 vaccines resulted in an estimated reduction of more than 265,000 COVID-19 infections and nearly 39,000 deaths among Medicare beneficiaries.  This study follows a September 25 directive by HHS Secretary Xavier Becerra authorizing all Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program providers to make available and administer Pfizer-BioNTech booster doses to all eligible individuals.  In addition, Secretary Becerra also made clear in June to insurers and providers that patients must have access to all COVID-19 tests and vaccines free of charge. 

New Study Finds One out of Five Hundred Children Lost a Primary Caregiver During the Pandemic 
According to a new study published in the journal Pediatrics that surveyed mortality, fertility, and census data, 140,000 children have lost a primary or secondary caregiver due to the COVID-19 pandemic.  This means that for every four COVID-19 deaths in the United States, a child lost a caregiver.  The resulting loss can be linked to mental health issues, shorter schooling, lower self-esteem, increased risk of substance abuse, and exploitation, among other severe consequences.  The loss of caregivers to the pandemic has also had a disproportionate impact on children of color.  The study was a done in collaboration between the Centers for Disease Control and Prevention (CDC), Imperial College London, Harvard University, Oxford University, and the University of Cape Town, South Africa. 

Non-NIH Grants

OPPORTUNITY NUMBER	OPPORTUNITY TITLE	AGENCY NAME	CLOSE DATE
HRSA-22-106	Service Area Competition-Additional Areas: Colebrook, NH and San Juan, PR	Health Resources and Services Administration	10/25/2021
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
HRSA-22-007	Service Area Competition	Health Resources and Services Administration	11/1/2021
RFA-CK-22-003	Emerging Infections Sentinel Networks (EISN) Research	Centers for Disease Control and Prevention - ERA	11/1/2021
CDC-RFA-CE22-2202	E-Learning Collaborative for Sexual Violence and Intimate Partner Violence Prevention	Centers for Disease Control - NCIPC	11/17/2021
RFA-FD-22-003	Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional	Food and Drug Administration	11/29/2021
RFA-OH-22-004	World Trade Center Health Research related to WTC Survivors (U01-No Applications with Responders Accepted)	Centers for Disease Control and Prevention - ERA	12/7/2021
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
PA-18-794	AHRQ Small Research Grant Program (R03)	Agency for Health Care Research and Quality	7/6/2022
PA-18-795	AHRQ Health Services Research Projects (R01)	Agency for Health Care Research and Quality	7/6/2022
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-21-266	Patient Safety Learning Laboratories: Advancing Patient Safety through Design, Systems Engineering, and Health Services Research (R18 Clinical Trial Optional)	Agency for Health Care Research and Quality	1/26/2023
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
PA-21-202	AHRQ/PCORI Learning Health System Small Grant Pilot Program	Agency for Health Care Research and Quality	6/19/2023
PAR-18-604	Vet-LIRN Network Capacity-Building Projects	Food and Drug Administration	9/2/2023
PAR-18-799	K01 Mentored Research Scientist Development Award	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-18-798	NIOSH Exploratory/Developmental Grant Program (R21)	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-18-797	NIOSH Small Research Grant Program	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-18-812	Occupational Safety and Health Research (R01)	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-21-179	Minor Use Minor Species Development of Drugs (R01)	Food and Drug Administration	2/3/2024
PA-21-267	Making Health Care Safer in Ambulatory Care Settings and Long-term Care Facilities (R18)	Agency for Health Care Research and Quality	5/26/2024
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
PA-21-264	Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18)	Agency for Health Care Research and Quality	5/26/2025
PA-21-265	Large Research Projects for Prevention of Healthcare-Associated Infections (R01)	Agency for Health Care Research and Quality	5/26/2025
RFA-FD-22-001	Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required	Food and Drug Administration