House Bill Proposes Increased Funding for NIH & NIDCR

Today, the Fiscal Year (FY) 2017 House Labor, Health and Human Services, and Education (LHHS) Appropriation bill was approved by the House Appropriations Committee by a 31-19 vote. This legislation proposes $33.3 billion for the National Institutes of Health (NIH) an increase of $1.25 billion over FY16 and $425.6 million for the National Institute of Dental and Craniofacial Research (NIDCR) which is $12.2 million over the enacted FY16 level of $413.4 million. Some of the increases for NIH were provided for the following initiatives:

  • $300 million, an increase of $100 million for Precision Medicine;
  • $1.26 billion, an increase of $350 million for Alzheimer’s disease research;
  • $195 million, an increase of $45 million, for the BRAIN Initiative to map the human brain;
  • And increases to every Institute and Center to continue investments in innovative research that will advance fundamental knowledge and speed the development of new therapies, diagnostics, and preventive measures to improve the health of all Americans.

The House proposed funding level is significantly less than the Senate LHHS bill which proposed $34 billion for NIH and $430.5 million for NIDCR. During the full committee mark-up Rep. Cole (R-OK), Chair of the LHHS Appropriations Subcommittee indicated the committee would like to build upon the $2 billion increase provided for NIH last year. He also stated the House funding level for NIH in this bill to be viewed as the “floor,” and not the ceiling and hoped the funding level for NIH can increase even further in the final appropriations bill.

The House LHHS Committee report also included report language pertinent to NIDCR. Specifically:

  • Mission: The mission of NIDCR is to improve the Nation’s oral, dental and craniofacial health through research and research training. NIDCR accomplishes its mission by performing and supporting basic and clinical research; conducting and funding research training and career development programs to ensure that there is an adequate number of talented, well-prepared, and diverse investigators; and coordinating and assisting relevant research and research- related activities. The Committee expects the Institute to systematically coordinate through other HHS agencies to share new scientific information to ensure it reaches the community and providers through various other HHS outreach programs.
  • Biomaterials: The Committee understands biomaterials are an important section of biomedical research. The Committee encourages NIDCR to consider efforts to encourage an increased focus on the development and innovation of dental materials.

However, since the overall allocation for this bill is $569 million below the FY16 enacted level, the proposed increased funding came at the expense of other important public health programs. Specific cuts include:

  • $110 million for the CDC Office of Smoking and Health
  • $54 million for the Agency for Healthcare Research and Quality

Below is additional information about programs of importance to AADR:

  • HRSA Title VII Training in Oral Health Care received $35.8 million which is level with FY16. The Committee recommends $35,873,000 for Training in Oral Health Care programs, which is the same as the fiscal year 2016 enacted level and the fiscal year 2017 budget request. Within the funds provided, the Committee includes not less than $10,000,000 for General Dentistry Programs and not less than $10,000,000 for Pediatric Dentistry programs. These programs serve to increase the number of medical graduates from minority and disadvantaged backgrounds and to encourage students and residents to choose primary care fields and practice in underserved urban and rural areas. HRSA is directed to provide continuation funding for predoctoral and postdoctoral training grants initially awarded in fiscal year 2015 and continuation funding for section 748 Dental Faculty Loan Repayment grants initially awarded in fiscal year 2016.
  • HRSA Area Health Education Centers. The Committee encourages HRSA to support AHEC oral health projects that establish primary points of service and address the need to help patients find treatment outside of hospital emergency rooms. The Committee is aware that some State dental associations have already initiated programs to refer emergency room patients to dental networks. HRSA is urged to work with these programs.
  • HRSA Dental Reimbursement Program. The Ryan White Part F program provides for the Dental Reimbursement Program (DRP), which covers the unreimbursed costs of providing dental care to persons living with HIV/AIDS. Programs qualifying for reimbursement are dental schools, hospitals with postdoctoral dental education programs, and colleges with dental hygiene programs. The Committee is concerned that although the program has provided oral health care to many people living with HIV/AIDS, it has not kept pace with the number of individuals in need. The Committee requests an update in the fiscal year 2018 budget request on the non-reimbursed costs covered by the DRP.
  • HRSA Maternal and Child Health Bureau Prenatal Oral Health – Set-aside for Oral Health. The Committee has included$250,000 for demonstration projects to increase the implementationof integrating oral health and primary care practice. The projects should model the core clinical oral health competencies for non-dental providers that HRSA published and initially tested in its 2014 report, ‘‘Integration of Oral Health and Primary Care Practice.’’
  • HRSA Rural Health Training in Oral Health Care and Rural Health.—The Committee encourages HRSA to work with States to develop and facilitate public education programs that promote preventive oral health treatments and habits via increased oral health literacy in rural and underserved areas. The Committee believes that prevention centered programs represent a cost effective way to address oral health access. The Committee also encourages the Office of Rural Health Policy to support these programs. Further, the Committee encourages HRSA to include innovative public education programs as eligible for funding as part of the State Oral Health Workforce Improvement Program.
  • HRSA Program Management. The Committee is disturbed to learn that despite its directive in House Report (110–231) to establish a Chief Dental Officer (CDO) position, HRSA has not maintained the appointment. The Committee understands that since the beginning of 2012 the position has been downgraded to Senior Dental Advisor and moved several layers below HRSA leadership and decision makers. This has occurred in spite of the Administration’s commitment in 2010 to establish the Oral Health Initiative, which highlighted several HRSA initiatives to improve access to oral health care, especially for needy populations. The Committee directs HRSA to restore the position of HRSA Chief Dental Officer with executive level authority and resources to oversee and lead HRSA dental programs and initiatives. The CDO is also expected to serve as the agency representative on oral health issues to international, national, State, and/or local government agencies, universities, oral health stakeholder organizations, etc.
  • CDC Division of Oral Health received $18 million which is level with FY16. The Committee expects the DOH to distribute new waterline safety guidelines to dentist offices and clinics, to coordinate with NIH to conduct follow up research where needed, and for CDC to work with professional organizations to educate dentists and dental students of such guidelines.

 What is Next? This is an important step in the legislative process. Given that it is an election year it is very likely that Congress will approve a short term continuing resolution funding the federal government through the November elections. Depending on the outcome of the election Congress will either develop an omnibus appropriation bill funding the federal government through the rest of the year; approve another short term continuing resolution or just approve a year long continuing resolution.

AADR will continue to closely monitor these developments and advocate on behalf of our members to secure the higher level funding for NIH, NIDCR and other oral health programs in the upcoming months.

 For More Information:

  • Click here to read the House Appropriations Committee Summary of the bill.
  • Click here to read the FY17 LHHS Bill Report Language.

 

AADR Supports First CHF Public Health Fair on Capitol Hill

By KyuLim Lee

CHF Public Health Fair

Carolyn Mullen, AADR Director of Government Affairs and KyuLim Lee, AADR Gert Quigley Fellow showcase our members work on salivary diagnostics.

AADR was proud to co-sponsor and exhibit at the Coalition for Health Funding’s (CHF) first Public Health Fair on July 13th CHF, established in 1970, is the oldest and largest nonprofit coalition working to preserve and strengthen public health investments. The Coalition is comprised of over 95 member organizations and together is the leading voice for preserving and strengthening public health investments.

The CHF Public Health Fair took place in the House Cannon Caucus Room, Washington, DC. The overarching goal was to educate members of Congress and their staff about the value and importance of public health. The event was formally initiated with welcoming remarks by Representatives Rob Wittman (R-VA) and Gene Green (D-TX). Rep. Wittman stressed that with the emerging diseases, public health is more important than ever and it truly is public health and public health professionals that will be a critical part of health care solutions in the future.

The great work of over 45 exhibitors, including federal agencies, was demonstrated at this fair. Each booth represented individuals working every day in communities across the nation to make America a healthier place, whether it be through preventive health such as early screenings and community health initiatives, health research that identifies cures, services that ensure access to care by needed individuals, health surveillance that prevents and responds to diseases, or education of the next generation public health professionals.

Exhibitors at the CHF Public Health Fair set up their booths in the House Cannon Caucus Building

AADR and Friends of NIDCR showcased salivary diagnostics research funded by National Institute of Health (NIH) and National Institute of Dental and Craniofacial Research (NIDCR), and great promise saliva has as a diagnostic/screening tool for both oral and systemic diseases. Our booth also included two point of care salivary diagnostics devices including the Programmable Bio-Nano-Chip (p-BNC) developed by the McDevitt Group and another the Electric Field-induced Release and Measurement 16 1.0 (EFIRM16 1.0) developed by EZLife Bio. Inc.

For More Information:
Click here to read our fact sheet about salivary diagnostics
Click here to learn about the Coalition for Health Funding

Senate Committee Approves Legislation Reauthorizing NSF

On June 23, 2016 the Senate Committee on Commerce, Science, Transportation approved the American Innovation and Competitiveness Act (S.3084). This legislation reauthorizes the National Science Foundation and the National Institute of Standards and Technology (NIST) for fiscal year (FY) 2017 and FY18. Importantly, the bill proposes a 4% increase in funding for NSF from FY17-FY18. According to the bill sponsors Sens. Gardner (R-CO) and Peters (D-MI) this legislation was introduced to “maximize science research by reducing administrative burdens for researchers, enhancing agency oversight, improve research dissemination, and reform federal science agencies to increase the impact of taxpayer-funded research.”

During the committee mark-up many Senators applauded the bipartisan effort to reauthorize these federal agencies. However, Sen. Fischer (R-NE) indicated her opposition to the bill because the increased authorization levels were not fully offset. According to an analysis by the American Institute for Physics her opposition may indicate that the Senate will have trouble passing the bill by unanimous consent.

While the Coalition for National Science Funding expressed their appreciation for the bill the Coalition encouraged the Committee to include, “a longer authorization (timeframe) that sets aspirational funding targets to inform appropriators of the resources the agency needs to accomplish its important mission.”

What is next? Given the limited legislative calendar it is unclear when or if the Senate will have enough time to consider this legislation. AADR will continue to monitor these efforts in conjunction with the broader science advocacy community.

Additional Information: This bill contains other important provisions listed below.

Highlights of the American Innovation and Competitiveness Act (S. 3084)

Authorization of Appropriations

  • Authorizes $7.5 billion in fiscal year 2017 and $7.8 billion in fiscal year 2018 for NSF
  • Authorizes $974 million in fiscal year 2017 and $1.013 billion in fiscal year 2018 for NIST

Maximizing Basic Research

  • Peer review – Reaffirms the NSF’s merit-based peer review process
  • Broadening research opportunities to stimulate Competitive Research (EPSCoR) for underutilized regions to reflect its established record
  • Cybersecurity research – Directs research to increase in the protection of computer systems from cyber threats.
  • Transparency and accountability – Codifies reforms to increase transparency and accountability in the NSF grant-making process.
  • Oversight implementation – Requires NSF to address concerns about waste and abuse by improving oversight of large research facility construction, updates a conflicts of interest policy, and reforms management of the Antarctic research program.

Reducing Regulatory Burdens

  • Interagency working group – Establishes an Office of Management and Budget (OMB) and OSTP-led interagency working group to reduce administrative burdens on federally-funded researchers.
  • Obsolete reporting requirements – Repeals obsolete federal agency reporting requirements as well as previous authorizations for programs that have not been implemented.

Science, Technology, Engineering, Mathematics (STEM) Education

  • Outside advisory panel – Authorizes a STEM education advisory panel of outside experts to help guide federal STEM education program decision making.
  • Expands opportunities for women – Expands NSF grant programs to increase participation and expand STEM opportunities to women and other under-represented groups.
  • Scientific and Technical collaboration—Requires the OMB in consultation with OSTP and the heads of other relevant agencies to revise current policies and streamline processes for attendance at scientific and technical workshops while ensuring appropriate oversight, accountability and transparency.

Manufacturing, Commercialization, and Leveraging the Private Sector

  • Crowdsourcing Science – Expands opportunities for crowdsourcing research input and citizen science participation by organizations and individuals.
  • Manufacturing – Updates NIST’s Hollings Manufacturing Extension Partnership (MEP) Program for small and medium sized businesses by adjusting the federal cost-share requirement and implementing new accountability and oversight requirements.
  • Promoting entrepreneurship – Authorizes and expands NSF’s Innovation Corps program to promote entrepreneurship and commercialization education, training, and mentoring of federally-funded researchers.
  • Commercialization grants – Authorizes and expands grants to promote the commercialization of federally-funded research.

 

For full press release: https://www.commerce.senate.gov/public/index.cfm/2016/6/commerce-approves-american-innovation-and-competitiveness-act-nine-other-bills-multiple-nominations

NIH Announces Single IRB Policy to Streamline Reviews of Multi-Site Reserach

The National Institutes of Health (NIH) recently released a new policy regarding the use of a single institutional review board of record for multi-site research. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subject at 25 CFR Part 26.
This policy will apply to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. It also includes contract solicitations issued on or after May 25, 2017. However ongoing, non-competing awards will not be expected to comply with this policy.

According to Dr. Collins, “Today, the time it takes to go from a sound research idea to the launch of a new, multi-site clinical research study is too long. A major contributor to the delay is that too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants. To address this bottleneck, NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States.”

For more information please click the following links below:

HHS Releases Oral Health Strategic Framework 2014-2017

By KyuLim Lee, AADR Gert Quigley Fellow

Earlier this year, the U.S Department of Health and Human Services (HHS) released the HHS Oral Health Strategic Framework 2014-2017 (the Framework). The Framework reflects the collective discussions and future plans proposed by HHS and other federal partners committed to improve oral health and overall health of the public.  The Framework is built upon five overarching goals proposed by the HHS and presents associated strategies designed from collaborative partnership of HHS resources, programs, and leadership commitment to improve collaboration on oral health activities of other federal partners. The five goals are listed below:

  • Integrate oral health and primary health care.
  • Prevent disease and promote oral health.
  • Increase access to oral health care and eliminate disparities.
  • Increase the dissemination of oral health information and improve health literacy.
  • Advance oral health in public policy and research.

The Framework reflects the most recent demonstration of the federal government’s commitment to oral health. The central vision is to increase the public’s understanding that oral health is an integral part of the overall health. During a recent webinar informing the public about the strategic framework, Dr. Bruce Dye DDS, MPH, a Dental Epidemiology Officer at the National Institute of Dental and Craniofacial Research, discussed that one of the biggest challenges towards implementing the vision laid out in the framework is the full integration of oral health and primary health care, and emphasized the need of dental and non-dental providers to work more collaboratively with one another.  He also discussed the possibility of encouraging the Institute of Medicine and or the Surgeon General to issue an updated report on the status of oral health in our country given that these reports are almost 20 years  old. Lastly, dissemination of oral health information (Goal 4) and advancing oral health in public policy and research (Goal 5),were highlighted following questions raised during the webinar about research on e-cigarettes given recent data indicating the increased utilization of these products. To improve the understanding of the effects of e-cigarettes, NIDCR recently awarded a number of grants to investigate the effects of these chemicals from e-cigarettes on oral health.

The next step to implement the strategies laid out in the Framework is to have the strategic efforts continue to be monitored and updated by participating federal agencies. Moreover, data generated via the Healthy People 2020 initiative will prove to be a useful benchmark to monitor progress. Furthermore, input from oral health stakeholders, including researchers and public health advocates will be crucial for this ongoing process as they move forward with the goal of improving oral health for all Americans.

For Additional Information:

Public Health Reports: www.publichealthreports.org
Oral Health Coordinating Committee: http://www.hrsa.gov/publichealth/clinical/oralhealth/ohcc.html
Webinar: http://www.publichealthreports.org/webinars.cfm

AADR Joins Community in Support of Department of Defense Medical Research Funding

Last week AADR joined 137 organizations in a letter to Sens. John McCain (R-AZ) and Reed (D-RI) in opposition to language included in the fiscal year 2017 National Defense Authorization Act. This language would have prohibited funding for DOD medical research unless it adhered to a narrowly defined criteria related to military relevance. Fortunately, due to the advocacy of the broader medical research community this language was stripped via an amendment authored by Sen. Durbin (D-IL) by a vote of 66-32.

AADR along with the American Dental Association (ADA) will continue to closely monitor these developments and any other legislation that may impact military dental research funded by the DOD.

AADR Submits Comments on Trans-NIH Plan for HIV-Related Research

Last week, AADR submitted comments on the National Institutes of Health (NIH) Request For Information (RFI) regarding the development of the fiscal year 2018 Trans-NIH Plan for HIV-Related Research. This plan is designed to identify and articulate possible future directions to maximize benefits of investments in HIV/AIDS research. AADR’s comments emphasized the high priority role of the oral cavity in the specific areas of HIV vaccines; mircrobicides and PrEP; cure research; test and treatment; pathogenesis and comorbidities; and health disparities research. AADR also encouraged the plan to emphasize the importance of training the next generation of oral health researchers.

Senate Bill Proposes Increased Funding for NIH & NIDCR

Yesterday, the Fiscal Year (FY) 2017 Senate Labor, Health and Human Services, and Education (LHHS) Appropriation bill was approved by the Senate Appropriations Committee by a 29-1 vote. This legislation proposes $34 billion for the National Institutes of Health (NIH) an increase of $2 billion over FY16 and $430.5 million for the National Institute of Dental and Craniofacial Research (NIDCR) which is $17.1 million over the enacted FY16 level of $413.4  million.  Some of the increases for NIH were provided for the following initiatives:

  • $300 million, an increase of $100 million for Precision Medicine;
  • $1.39 billion an increase of $400 million for Alzheimer’s disease research;
  • $250 million, an increase of $100 million, for the BRAIN Initiative to map the human brain;
  • $333.4 million an increase of $12.5 million for the Institutional Development Award;
  • $463 million, an increase of $50 million, to Combat Antibiotic Resistance;
  • And increases to every Institute and Center to continue investments in innovative research that will advance fundamental knowledge and speed the development of new therapies, diagnostics, and preventive measures to improve the health of all Americans.

The Senate LHHS Committee report also included report language pertinent to NIDCR. Specifically:

  • Dental Materials.- Biomaterials is an important section of biomedical research for practicing dentists. The Committee urges NIDCR to continue to invest in the development and innovation of dental materials.
  • Overlapping Pain Conditions.- The Committee commends the NIDCR for its ongoing support for the Orofacial Pain Prospective Evaluation and Risk Assessment program, which is yielding valuable information on many physiological aspects of temporomandibular disorders and overlapping pain conditions. The Committee encourages continued research on overlapping pain conditions and increased collaboration across NIH Institutes on epidemiological, basic, clinical and translational research related to pain conditions.

During the committee markup Chairman Blunt (R-MO) emphasized this legislation was the first bi-partisan LHHS Appropriations bill developed in seven years. This legislation does not include any new policy riders. Many Senators applauded the increased funding for NIH as a critical step to build on the momentum of the previous fiscal year. However, since the overall allocation for this bill is $270 million below the FY16 enacted level, the proposed increased funding came at the expense of other important public health programs. Specific cuts include:

  • -$118 million for the Centers for Disease Control and Prevention
  • -$2 million for the CDC Division of Oral Health
  • -$10 million for the Agency for Healthcare Research and Quality
  • -$4.4 million for the National Center for Health Statistics

Below is additional information about programs of importance to AADR:

  • HRSA Title VII Training in Oral Health Care received $35.8 million which is level with FY16. The Committee provides $35,873,000 for Training in Oral Health Care programs which includes not less than $10 million each for general and pediatric dentistry. Funds may be used to expand training in general dentistry, pediatric dentistry, public health dentistry, dental hygiene and other oral health access programs. Funds may also be used to plan and operate training programs as well as to provide financial assistance to students and residents. The agency is directed to provide continuation funding for predoctoral and postdoctoral training grants initially awarded in fiscal year 2015 for Section 748 Dental Faculty Loan Program grants initially awarded in fiscal year 2016. The Committee understands that since the Chief Dental Officer was created at HRSA, the position has been downgraded to Senior Dental Advisor. The Committee strongly encourages HRSA to restore the position of Chief Dental Officer with executive level authority and resources to oversee and lead HRSA dental programs and initiatives. The CDO is also expected to serve as the agency representative on oral health issues to international, national, State, and/or local government agencies, universities and oral health stakeholder organizations. The Committee continues long-standing bill language that prohibits funding for section 340 G-1 of the PHS Act.
  • HRSA AIDS Dental Services The Committee provides $13,122,000 for the AIDS Dental Services program. This program provides grants to dental schools, dental hygiene schools, and postdoctoral dental education programs to assist with the cost of providing un reimbursed oral health care to patients with HIV. The Ryan White Part F program provides for the Dental Reimbursement Program [DRP] which covers the unreimbursed costs of providing dental care to persons living with HIV/AIDS. Programs qualitying for reimbursement are dental schools, hospitals with postdoctoral dental education programs, and colleges with dental hygiene programs.
  • HRSA Maternal and Child Health Bureau Prenatal Oral Health.- The Committee encourages HRSA to utilize demonstration projects to support the implementation of integrating oral health and primary care practice. The projects should model the core clinical oral health competencies for non-dental providers that HRSA published and initially tested in its 2014 report, “Integration of Oral Health and Primary Care Practice.”
  • CDC Division of Oral Health received $16 million which is a $2 million decrease from FY16.

What is Next? This is an important first step in the legislative process. The House still needs to consider its version of the LHHS bill which is expected to happen sometime during the week of June 20th. Given that it is an election year it is very likely that Congress will approve a short term continuing resolution funding the federal government through the November elections. Depending on the outcome of the election Congress will either develop an omnibus appropriation bill funding the federal government through the rest of the year; approve another short term continuing resolution or just approve a year long continuing resolution.

AADR will continue to closely monitor these developments and advocate on behalf of our members to secure increased funding for NIH, NIDCR and other oral health programs in the upcoming months.

 

FDA Extends Authority to All Tobacco Products, Including E-Cigarettes, Cigars and Hookah

Recently, the Food and Drug Administration issued a final rule effective August 8, 2016 Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act. This rule extends FDA’s authority to include the regulation of electronic nicotine delivery systems, all cigars, hookah tobacco, pipe tobacco and nicotine gels that went on sale after February 15, 2007.  According to a press release issued by the FDA this new rule would also ban the sale of e-cigarettes, hookah or cigars to anyone under the age of 18. The new rule also includes the following:
 
  • Registering manufacturing establishments and provide product listings to the FDA
  • Reporting ingredients and harmful and potentially harmful constituents
  • Requiring premarket review and authorization of new tobacco products by the FDA
  • Placing health warnings on product packages and advertisements
  • Not selling modified risk products unless authorized by the FDA
  • Not allowing the selling to tobacco products in vending machines
  • Not allowing the distribution of free samples. 
The new rule does not ban flavored tobacco products including e-cigarettes, nor does it ban advertising of products. 
 
What is next? According to an article in the Hill, a leading manufacturer of e-liquids has filed a lawsuit in the federal district court in Washington, D.C. challenging the deeming rule. Also, some members of Congress are leading efforts to attach policy riders to the Agriculture appropriations bills limiting FDA’s authority to implement this rule. AADR joined the broader public health community by sending a letter to the House Appropriations Committee and a separate letter to the Senate Appropriations Committee voicing our opposition to these policy riders. We will continue to monitor these efforts and advocate for FDA to have the authority to oversee all tobacco products, including e-cigarettes. 
 
Additional Information: For additional information the FDA Center for Tobacco Products (CTP) hosts a series of webinars on federal tobacco regulations. These webinars are designed to provide FDA tobacco compliance education and information to retailers and to small business manufacturers. Sign up to receive email updates about this webinar series.

House Subcommittee Approves Funding for NSF

This week, the House Commerce, Justice and Science (CJS) Appropriations Subcommittee approved its fiscal year 2017 appropriation bill. The CJS bill proposes funding allocations for the Department of Commerce, the Department of Justice, the National Aeronautics and Space Administration (NASA), the National Science Foundation (NSF) and other agencies. For NSF specifically, the House allocated approximately $7.4 billion, $57 million below the fiscal year 2016 enacted level and $158 million below the President’s budget request. According to a fact sheet released by the Subcommittee Research and Related Activities were increased by $46 million and reductions were made to equipment and construction costs.

AADR will continue to closely monitor these developments and work in partnership with the Coalition for National Science Funding as this bill moves forward.