e-Public Policy Update – December 2016

Contents:

  • Cures Act Enacted into Law
  • President Signs Stopgap Funding Measure, Deferring Spending Decisions Until April 28
  • ASM Statement on the 2016 Presidential Election Results
  • ASM Participates in FDA Commissioner Listening Session
  • ASM Staff Attend CDC AMD Program External Peer Review
  • National Institutes of Health Releases Guidance on Postdoctoral Stipends
  • ASM Staff Attend FDA Microbiology Devices Panel Meeting
  • ASM, AMP and PASCV Express Concerns over Newest Molecular Test for Zika
  • ASM Joins PEW, IDSA and BD in Senate HELP Committee Letter on Breakpoints
  • ASM Joins November CCCLW Meeting
  • Minority Microbiology Mentor Newsletter

Cures Act Enacted into Law
The 21st Century Cures Act was signed into law by President Obama on December 13, 2016. One of the main goals of the legislation is to reduce the paperwork burden for biomedical researchers. The bill also provides relief from travel restrictions for scientific meetings, allows for data sharing and improves privacy protection of information about research participants. Provisions in the Cures Act establish an NIH office to promote policies to improve coordination and analysis of opportunities for new and early stage investigators, as well as attracting, retaining, and developing emerging scientists in priority research areas. The strategies include developing early-stage researchers who are women or members of groups that are traditionally underrepresented in biomedical research careers. The Cures Act authorizes the establishment of additional programs to assist in the repayment of student loans and raises the cap on the repayment assistance available to researchers.

The Cures Act authorizes $4.8 billion in  multiyear funding for three scientific initiatives launched by the Obama administration: the Brain Research through Advancing Innovative (Neurotechnologies (BRAIN) Initiative), the Precision Medicine Initiative (PMI),  and the Beau Biden Cancer Moonshot. It also includes a new research initiative focused on regenerative medicine. Congress appropriated $352 million for the NIH for these specific programs in FY 2017 but postponed the overall fiscal year 2017 funding level for the federal government to support all NIH research across disciplines until April 2017.

The Office of Public Affairs prepared an analysis of the Act’s provisions for the NIH and the Food and Drug Administration.

President Signs Stopgap Funding Measure, Deferring Spending Decisions Until April 28
The President December 10 signed a continuing resolution (CR) that would extend funding for most federal agencies, including the National Institutes of Health (NIH) and other science and health agencies, at a rate of operations that is 0.1901 percent below fiscal year (FY) 2016 levels until April 28, 2017. In addition to continuing funding for the NIH budget, the CR (H.R. 2028) enables NIH to access $352 million in funding available to NIH in FY 2017 through the Innovation Account established in the 21st Century Cures Act (H.R. 34). In FY 2017, the Account provides $40 million for the Precision Medicine Initiative, $10 million for the BRAIN Initiative, $300 million for Cancer Moonshot, and $2 million for clinical regenerative medicine research. 

ASM Statement on the 2016 Presidential Election Results
The ASM issued a press release regarding the new Administration and Science.  “The new Administration has a great opportunity to continue to strengthen research and development efforts in order to keep our scientific leaders on the cutting edge of experimentation, exploration, and advancement. This investment will have substantial benefits for the U.S. economy and the American quality of life,” said Susan Sharp, President.  The ASM identified three priority areas that the new Administration should address that will directly benefit the American public: combatting drug-resistant infectious diseases, dedicating a federal fund for rapid responses to microbial outbreaks, and promoting the commercial potential of a U.S. bioeconomy.  The entire press release and ASM’s recommendations to the presidential transition are available on-line.

ASM Participates in FDA Commissioner Listening Session
ASM Public Affairs staff, Janet Shoemaker and Kimberly Walker participated in the FDA Commissioner Listening Session on Rare Diseases, Rheumatology, Infectious Disease and Cystic Fibrosis in December.  FDA requested that ASM provide perspectives and concerns on priority issues challenging the microbial sciences.  Issues related to antimicrobial resistance and antimicrobial resistance susceptibility methods, the FDA oversight of infectious disease next generation sequencing based diagnostic, oversight of laboratory developed tests (LDTs) and protocols for duodenoscopes were discussed. 

ASM Staff Attend CDC AMD Program External Peer Review
ASM staff attended the December external peer review of the Centers for Disease Control and Prevention’s Advance Molecular Detection (AMD) program.  This meeting consisted of a review of AMD progress and challenges and included reports on PulseNet, metagenomics for identification of pathogens from clinical samples, influenza virus surveillance, and the introduction of MicrobeNet, an online virtual reference laboratory.  While the AMD panel met in closed session, external peer representatives were taken on a tour of the facilities, featuring the latest sequencing platforms and data analysis tools. 

National Institutes of Health Releases Guidance on Postdoctoral Stipends
NIH released guidance that recipients of Kirschstein-NRSA institutional training grant and individual fellowship awards supporting currently active postdoctoral trainees or fellows with 0, 1, or 2 years of experience as of December 1, 2016, will received increased stipends. The Notice also provides instructions for requesting one-time supplemental funding to cover the stipend increase. 

ASM Staff Attend FDA Microbiology Devices Panel Meeting
ASM staff attended the November 9 FDA Microbiology Medical Devices Panel of the Medical Devices Advisory Committee; the topic of the meeting was reclassification of CMV, EBV, and BK viral load tests from Class III to Class II devices.  As this reclassification has the potential to affect laboratory practice, ASM and the Pan American Society for Clinical Virology (PASCV) made joint comments on the transplant virus testing, indicating support for the proposal.   

ASM, AMP and PASCV Express Concerns over Newest Molecular Test for Zika
In light of recent concerns regarding test performance characteristics of the Trioplex rRT-PCR assay for identification of Zika, dengue and chikungunya viruses, ASM, the Association for Molecular Pathology (AMP), and PASCV authored a joint letter to the Centers for Disease Control and Prevention (CDC) requesting additional data on this test. 

ASM Joins PEW, IDSA and BD in Senate HELP Committee Letter on Breakpoints
The ASM, Pew Charitable Trusts, Infectious Diseases Society of America, and Becton, Dickinson and Company (BD), jointly authored a letter to the Senate Health, Education, Labor and Pensions (HELP) committee requesting support of Section 2121 of H.R. 6, “The 21st Century Cures Act,” which would streamline the process of updating antibiotic breakpoints.  The just signed Cures bill provides FDA with the authority to rely on third party experts when updating guidelines for drug susceptibilities and which infections the drug is useful in treating.

ASM Joins November CCCLW Meeting
The Coordinating Council on the Clinical Laboratory Workforce (CCCLW) is a coalition of laboratory organizations working together to ensure a high quality workforce.  The November 14 meeting, which ASM staff attended with other members of the coalition, included the roll-out of the newly updated website, and discussion of upcoming projects.  The official ASM representative to CCCLW is Professional Affairs Committee member Janice Matthews-Greer.

Minority Microbiology Mentor Newsletter
The November issue of the Minority Microbiology Mentor Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities.

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