e-Public Policy Update - April 2012

ASM Submits Written Testimony to Congress on R&D Funding
In March, the ASM submitted recommendations to Congress supporting increased research and public health program funding for Fiscal Year 2013 appropriations for the federal agencies that support public health progams, biomedical, agricultural and environmental research.  Highlights of the ASM recommendations include:

National Institutes of Health (NIH): ASM urged lawmakers to increase funding for the NIH above the Administration’s proposed flat level funding of $30.7 billion to no less than $32 billion in FY 2013.  ASM emphasized that this funding recommendation represents the minimum level necessary to pursue research opportunities and to keep pace with biomedical inflation.

Centers for Disease Control and Prevention (CDC): ASM voiced concern over the proposed FY 2013 budget for the CDC, a $664 million or 11.6 percent decrease from FY 2012 and asked Congress to reverse the recent trend of cuts to the CDC budget and core infectious disease programs.  ASM highlighted public health impacts of infectious disease reemergence and inadequate funding to CDC but also supported CDC areas that received proposed increases including the additional $27 million for the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID).

Food and Drug Administration (FDA): ASM pointed out that the Administration’s FY 2013 request of $4.5 billion for the FDA includes nearly $2 billion in current and proposed user fees from regulated industries (45 percent of the total), and stressed that the proposed net budget increase of only $11.5 million in FY 2013 would not be adequate to sustain the FDA’s critical role in public health. ASM requested Congress increase funding for the FDA to support its research centers, initiatives and core programs to protect public health.

National Science Foundation (NSF): ASM endorsed the Administration’s FY 2013 budget request of $7.37 billion, a 4.8 percent increase over FY 2012 for the NSF and urged Congress to support basic research to sustain the NSF’s successes in STEM related education and academic research. 

Department of Agriculture (USDA) Research and Education: ASM encouraged Congress to fund research and education programs at the USDA with $2.6 billion, or a 2.7 percent increase over the FY 2012 level, and to support the President’s proposed budget for the Agriculture Food and Research Initiative (AFRI) of $325 million in FY 2013, a 23 percent increase over FY 2012.

Environmental Protection Agency (EPA) Research: ASM suggested Congress provide the EPA with a sustainable S&T budget to support research and development critical to the Agency’s mission. The Administration’s proposed budget is $807 million for science and technology at the EPA, a 2 percent increase.

Department of Energy (DOE) Office of Science: ASM said the Administration’s proposed budget for the DOE’s Office of Science of $5 billion is a minimal 2.4 percent increase over the FY 2012 level and recommended that Congress increase the level to support DOE research and development, critical to the nation’s future global competitiveness.

A booklet that includes the full ASM funding recommendations to Congress, Federal Funding for FY 2013:  Biomedical and Life Sciences Research is available on-line at: Research and Development Funding for FY 2013.

New Dual Use Research Policy Announced
On March 29, the US Government (USG) issued a new policy to conduct oversight of dual use research, following controversy stemming from experiments on avian influenza. The policy is available on the NIH Office of Biotechnology (OBA) website by clicking here.  The policy requires federal agency scrutiny of seven categories of research that involve a list of 15 select agents and toxins, including highly pathogenic avian influenza and the 1918 reconstructed influenza virus, in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The policy states that if the risks posed by the research cannot be adequately mitigated with measures outlined in the policy, federal departments will determine whether it is appropriate to request voluntary redaction of the research publications or communications, classify the research or not provide or terminate research funding. The definition of dual use research of concern is taken from the National Science Advisory Board on Biosecurity”s (NSABB) definition: “life sciences research that,  based on current understanding,  can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential  consequences to public health and safety, agricultural crops, and other plants, animals, the environment, materiel, or national security.” The policy states that the USG will continue to consult with the NSABB or convene the Countering Biological Threats Interagency Policy Committee for guidance on matters relating to the review and conduct of DURC and the mitigation of DURC risks. The policy statement did not include a public comment opportunity.

Following its meeting on March 29-30, the NSABB released a statement which is posted on the NIH OBA website describing its recommendations on the communication of two revised manuscripts regarding the transmissibility of A/H5N1 influenza virus (avian flu) in ferrets.  Earlier versions of the papers had been submitted for publication in Science and Nature and were reviewed by the NSABB. The Board said its recommendation to support full communication of the manuscripts was based on additional risk/benefit information and the newly released USG policy on Oversight of Life Sciences Research of Concern.

The ASM Public and Scientific Affairs Board (PSAB) has organized a Special Session at the ASM General Meeting on H5N1 Research and Dual Use Research Issues, which is scheduled for June 19 from 11:00 am to 1:30 pm.  The ASM also cosponsored the international Royal Society conference April 3-4 in London to address research issues surrounding H5N1 avian influenza research. Kenneth Berns, cochair of the PSAB Biodefense Committee, attended the meeting as the ASM representative.    The conference proceedings are online at: http://www.voiceprompt.co.uk/royalsociety/030412

FDA Guidance for Industry on Judicious Use of Antimicrobial Drugs in Animals
On April 11, the Food and Drug Administration (FDA) announced the publication of three documents in the April 13 Federal Register that are intended to phase out the use of antibiotics for growth promotion in food-producing animals. The FDA is proposing a voluntary initiative to phase in certain changes to how medically important antimicrobial drugs are labeled and used in food-producing animals.   Under the initiative, certain antibiotics would not be used for production purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illness in food-producing animals under the supervision of a veterinarian.

The FDA documents include:

  • a final Guidance for Industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs; Guidance Document GFI #209.    The Federal Register Notice for GFI 209 is available on-line.  Written comments can be submitted anytime to the Division of Dockets Management (HFA-305).
  • a draft guidance, open for public comment until July 12, will assist drug companies in voluntarily removing production uses of antibiotics from their FDA approved product labels; adding, where appropriate, scientifically supported disease prevention, control and treatment uses; and changing the marketing status to include veterinary oversight;  Draft Guidance Document GFI #213.   The Federal Register Notice for GFI 213 is available on-line.
  • a draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.  The Federal Register notice is available on-line. 

Comments for all of the Guidance Documents and proposed regulations are due July 12, 2012. 

ASM Cosigns Letter on Antibiotic Pipeline
The ASM cosigned a February 22 letter to Congress, prepared by the Infectious Diseases Society of America (IDSA), which urges the legislators to address the serious and growing problems of antimicrobial resistance and the dry pipeline for antibiotic research and development in upcoming Food and Drug Administration user fee legislation. The letter also asked Congress to incentivize the development of new related diagnostics and to strengthen federal efforts to promote appropriate use of antibiotics.  To read the letter go to:  http://www.asm.org/images/pdf/Policy/ar-hversion.pdf.

OSTP Report on Public Access to Scientific Research Results
On April 13, the Office of Science and Technology (OSTP) released a report to Congress on issues related to improving the management and access to the results of federally funded scientific research. The report was required by the America Competes Reauthorization Act of 2010 (ACRA).  The report says that the Task Force on Public Access to Scholarly Publications and a working group under the National Science and Technology Council (NSTC) have been evaluating objectives related to increasing public access to federally funded scientific research and that analysis of responses to requests for input show strong support for increasing access to scholarly publications describing research results. The NSTC groups are continuing to consider public comments and how they should be implemented.  The report is available at http://www.asm.org/images/pdf/Policy/ostp-publicaccess.pdf

OSTP Conference on “Grand Challenges” Innovation Strategy
On April 9 the White House Office of Science and Technology Policy (OSTP) announced on its blog  that this summer it will hold a conference on Grand Challenges, a part of the president’s Strategy for American Innovation that identifies “ambitious goals on a national scale that capture imagination and demand advances in innovation and breakthroughs in science technologies.” OSTP identifies sequencing the human genome as an example of a “grand challenge” and mentions the project’s impact on the nation’s economy. This summer’s conference will highlight existing Grand Challenge initiatives and “will recognize new commitments and actions by Federal agencies, companies, philanthropists, universities, and non-profits to set and meet Grand Challenges.”

Find the OSTP blog post at: http://www.whitehouse.gov/blog/2012/04/09/21st-century-grand-challenges