ASN Health and Nutrition Public Policy Newsletter
October 2, 2008
Executive Summary
President Bush signs a continuing resolution into law to fund the federal government at FY 2008 levels, with a few exceptions, through early March 2009, while a second attempt to pass an economic stimulus package, including additional funding for the National Institutes of Health (NIH), fails. Dr. Elias Zerhouni announces his intent to resign as Director of the agency later this month, and as the election draws nearer, the National Academies releases a report with recommendations for science and technology appointments in a new Administration.
- President Bush signs continuing resolution to fund government through early 2009
- Second stimulus package fails in the Senate, dashing hopes for additional research funding
- House passes bill to ensure funding for Community Food Projects
- ASN, with Friends of NCHS, sponsor Congressional briefing on health data
- Senate subcommittees hold hearing on marketing of foods to children
- Zerhouni to end tenure as Director of the National Institutes of Health¥ NIH to seek public input on conflict of interest
- NIH reveals timeline for the implementation of the revised peer review policy
- NIH creates “Early Stage Investigator” designation
- NIH announces $138 million in Director's Pioneer and New Innovator Awards for 2008
- NIH Grant Opportunity: Exploratory Studies in Cancer Detection, Diagnosis, and Prognosis
- FDA revises the Calcium, Vitamin D and Osteoporosis health claim
- FDA holds a meeting on advisory labeling of food allergens
- ARS updates database of isoflavone compounds in foods
- National Academies releases report on scientific appointments in a new Administration
- FASEB launches web-based NIH advocacy clearinghouse
- Trust for America's Health discusses F as in Fat
CONGRESSIONAL ACTION
Congress returns for pre-election session
It has been a rollercoaster ride in Washington over the past few days as Congress and the Bush Administration have wrangled over how to best address the current precarious economic situation and the ailing financial sector. When this newsletter went to press, the outcome of a $700 billion “bailout” bill was still unclear, though the cost of addressing this problem surely will impact the FY 2009 and FY 2010 budget, with potentially serious implications for domestic programs and priorities such as research funding.
President Bush signs continuing resolution to fund government through early 2009
Earlier this week, President Bush signed into law a continuing resolution (CR) to fund most federal government activities at fiscal year (FY) 2008 levels through March 6, 2009. FY 2009 spending bills for the Departments of Defense, Homeland Security and Veterans Affairs, as well as Military Construction, were rolled into the CR at higher levels than FY 2008. In addition, the CR included several exceptions and special funding provisions, including $150 million in supplemental funds for the Food and Drug Administration (FDA) and a FY 2009 appropriation of $6.65 billion for the WIC Food Program, which represents a $1 billion increase over the current level.
ASN, in conjunction with the Friends of the National Center for Health Statistics (NCHS), worked to secure an exception for the agency, which received a 10 percent boost, or $11 million increase, in the President's budget proposal and in both the House and Senate FY 2009 appropriation bills for the Department of Health and Human Services (HHS). Unfortunately, an exception was not made for the agency in the CR.
Republicans originally opposed the continuing resolution because it contained a continuation of a ban on offshore drilling in the Outer Continental Shelf that was set to expire on September 30th. Democrats abandoned the prohibition in order to secure passage of the bill and avoid a government shut down. Many Democrats, however, vowed to reinstate the offshore oil drilling ban in 2009.
Second stimulus package fails in the Senate, dashing hopes for additional research funding
The scientific community's hopes for additional research funding in 2008 were dashed when the Senate last Friday defeated a proposal for a $56.2 billion economic recovery package that would have provided an additional $1.2 billion for NIH. The Senate vote of 52-42 fell 8 votes short of the 60 needed for passage.
In addition to the boost for NIH, the bill proposed the following:
- $966 million to improve public health services to cope with a potential pandemic flu outbreak or the use of a biological weapon
- $46 million for the Centers for Disease Control and Prevention (CDC) for combating infectious diseases and investigating disease clusters.
- $250 million for the National Aeronautics and Space Administration (NASA) to speed development of the next U.S. space vehicle
- $150 million for the Department of Energy's Office of Science to protect and provide jobs at national laboratories and universities, continue research, and meet international science project obligations
- $100 million for nuclear security upgrades.
- $450 million for the WIC program and increased food assistance benefits under the Supplemental Nutrition Assistance Program (formerly the Food Stamp program)
The House passed a $60.8 billion second economic stimulus the same day, which focused on infrastructure projects, unemployment insurance, Medicaid and food assistance programs. The House bill did not include additional funds for research. Because the Senate has no plans to consider the House-passed bill and the White House had threatened to veto a second stimulus package, efforts to get a stimulus bill through Congress have been abandoned.
House passes bill to ensure funding for Community Food Projects
The House passed by voice vote S. 3597, legislation ensuring current year funding for the federal nutrition program Community Food Projects (CFP). The bill makes technical fixes to the Farm Bill passed earlier this year, thus ensuring FY 2008 funding for the program, which is designed to increase the access of fresh, nutritious food in low-income urban and rural areas. S. 3597 now goes to the President, who is expected to sign the bill. More information on the CFP Competitive Grants Program is available on the Community Food Projects website.
ASN, with the Friends of NCHS, sponsors Congressional briefing on health data
With the Friends of NCHS, ASN helped sponsor a Capitol Hill briefing on September 24 to showcase the data generated by the National Center for Health Statistics (NCHS) and educate Congressional staff on how such statistics can inform and support health policy decisions. In addition to Congressional staff, staff from the Congressional Research Service and representatives from member organizations of the Friends attended the briefing. Reps. Al Green (D-TX) and Michael Burgess (R-TX) served as honorary sponsors; speakers included NCHS Director Dr. Edward Sondik, Associate Director Dr. Linda Bilheimer, and NCHS analyst James Craver.
Sondik and Bilheimer provided an overview of the Agency's work and reviewed data from four of the NCHS surveys, including the National Health and Nutrition Examination Survey (NHANES). Slides from this briefing are available on the Friends of NCHS website and data from all the NCHS surveys – Health Data Interactive, Vital Stats, Healthy People 2010, and NHANES are available on the NCHS website.
Senate subcommittees hold hearing on marketing of foods to children
The Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education and the Subcommittee on Financial Services and General Government held a hearing entitled, "Watch What You Eat: Food Marketing to Kids." Led by Subcommittee Chairmen Tom Harkin (D-IA), Richard Durbin (D-IL) and Sen. Sam Brownback (R-KS), the hearing discussed issues related to marketing and advertising of food considered unhealthy to children. Witnesses at the hearing, including Federal Communications Commission (FCC) Chairman Kevin Martin, acknowledged that several food companies have restricted marketing to children, but pointed to the lack of voluntary compliance by other companies, particularly media companies, with recommendations for advertising to children made by the FCC and Federal Trade Commission (FTC). The hearing – involving government agencies such as the Centers for Disease Control and Prevention (CDC), the FTC and the FCC, in addition to the food industry, and the media industry – aimed to highlight the need for a comprehensive approach to changing the way food is marketed to children.
For more information, including a webcast of the hearing, visit the Senate Appropriations Committee website. Over the past couple of years ASN has weighed in on this issue. To view ASN press releases and statements visit the Press Releases page in the “News” section on ASN website.
ADMINISTRATIVE ACTION and GRANT OPPORTUNITIES
Zerhouni to end tenure as Director of the National Institutes of HealthNIH Director Elias A. Zerhouni, M.D., announced his plans to step down from the post at the end of this month to pursue writing projects and to explore other professional opportunities. Dr. Zerhouni, a physician scientist and world-renowned leader in radiology research, has served as NIH director since May 2002. One of the hallmarks of his tenure has been the NIH Roadmap for Medical Research, launched in 2003 after extensive consultations with the scientific community. The NIH Roadmap brought together all of the NIH's 27 Institutes and Centers to fund compelling research initiatives that could have a major impact on science, but that no single institute could tackle alone. “Dr. Zerhouni has been an outstanding leader of NIH during a time of great progress and many challenges, including flat funding from Congress. ASN has appreciated his attention to prevention and the continued support for nutrition research at NIH. The Society commends him for a job well done and wishes him well in future endeavors,” said ASN President James O. Hill. For more information, please visit the NIH News Room.NIH reveals timeline for the implementation of the revised peer review policy
The NIH Peer Review Oversight Committee and three subgroups consisting of NIH program, review, grants management and evaluation staff have developed an initial implementation timeline for the Enhancing Peer Review activity. The recommendations that are being implemented are based on the result of the diagnostic phase and significant dialogue with both the internal and external communities regarding enhancements to the review system. Although specific details of the implementation plans are still being worked out, the first of the preliminary implementation plans for the 2009 through 2010 calendar years are as follows:
Priority Area 1 – Engage the Best Reviewers
- Improve Reviewer Retention: In 2009, new reviewers will be given additional flexibility regarding their tour of duty, and other efforts will be undertaken to improve retention of standing review members.
- Recruit the Best Reviewers: A toolkit, incorporating best practices for recruiting reviewers, will be made available to all ICs in 2009.
- Enhance Reviewer Training: In spring 2009, training will be available to reviewers and SROs related to the changes in peer review.
- Allow Flexibility through Virtual Reviews: Pilots will be conducted in 2009 on the feasibility of using high-bandwidth support for review meetings to provide reviewers greater flexibility and alternatives for in-person meetings.
Priority Area 2 – Improve the Quality and Transparency of Review
- Improve Scoring Transparency and Scale: Review criteria-based scoring on 1 to 7 scale commences in May 2009. Reviewers will provide feedback through scores and critiques for each criterion in a structured summary statement.
- Provide Scores for Streamlined Applications: In 2009, streamlined applications will receive a preliminary score.
- Shorten and Restructure Applications: Shorter (12-page research plan) R01 applications (with other activity codes scaled appropriately) will be restructured to align with review criteria for January 2010 receipt dates.
Priority Area 3 – Ensure Balanced and Fair Reviews across Scientific Fields and Career Stages, and Reduce Administrative Burden
- Fund the Best Science Earlier and Reduce Need for Resubmissions: To ensure that the largest number of high quality and meritorious applications receive funding earlier and to improve system efficiency, NIH is considering separate percentiling of new and resubmitted applications and permitting one amended application.
- Review Like Applications Together: NIH is establishing an Early Stage Investigator (ESI) designation. In 2009, NIH will evaluate clustering ESI applications for review. The same approach will be considered for clinical research applications.
NIH creates “Early Stage Investigator” designation
NIH has published a notice describing changes in NIH New Investigator policies designed "to encourage early transition to independence." Under the policy, new investigators within 10 years of completing their terminal research degree or within 10 years of completing their medical residency will be designated Early Stage Investigators (ESIs). Traditional NIH research grant (R01s) applications from ESIs will be identified and the career stage of the applicant will be considered at the time of review and award.
The new classification stems from the concern that, in spite of persistent attention to the identification and funding of New Investigators, the duration of postdoctoral training has increased NIH hopes that by providing an advantage for ESIs, it will be able to directly encourage earlier application for NIH research grant support. Implementation will begin with R01 applications received for the February 2009 receipt date. More complete information on the ESI-related features of the eRA Commons; instructions to reviewers for consideration of ESI applications; grouping of applications from ESIs during peer review; the process and criteria for requesting an extension of the period of eligibility; and a series of Frequently Asked Questions (FAQs) will be developed between the issuance of this announcement and the February R01 receipt dates. For additional information, visit the NIH Grants website.
NIH announces $138 Million in Director's Pioneer and New Innovator Awards in 2008
The NIH has increased its support for and commitment to transformative research by awarding the 2008 NIH Director's Pioneer and New Innovator Awards to 47 scientists, many of whom are in the early stages of their careers. The grants, which could total as much as $138 million over five years, enable recipients to pursue exceptionally innovative research projects that have the potential to transform biomedical and behavioral science. Now in its fifth year, the Pioneer Award program has made 63 awards, 16 of them in 2008. The New Innovator Award program, launched in 2007, supports 61 investigators — 30 selected last year and 31 more this year. Each Pioneer Award provides $2.5 million in direct costs over five years. New Innovator Awards are for $1.5 million in direct costs over the same time period. For more information, please visit the NIH Press Room.
NIH Grant Opportunity: Exploratory Studies in Cancer Detection, Diagnosis and Prognosis
The National Cancer Institute (NCI) invites grant applications from institutions and organizations interested in developing and testing innovative methods in cancer detection, diagnosis, and prognosis. The NCI is especially interested in research studies that focus on the development and testing of improved methods for detecting specific characteristics of cancer, which can be subsequently used for the clinical management of cancer patients or individuals who are at risk for (developing) cancer. It is important that research studies focus on the search for molecular and cellular differences between tumors, pre-malignant, or normal tissues. The studies should determine the clinical translational significance of these differences by correlation with clinical parameters, in order to answer clinical problems related to detection, diagnosis, treatment, and prognosis. This FOA utilizes the NIH Exploratory/Developmental Grant (R21) mechanism. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications; therefore, the anticipated number of awards is not known. For more information, please visit Grants.gov.
FDA revises the Calcium, Vitamin D and Osteoporosis health claim
In a final rule effective January 1, 2010, the Food and Drug Administration (FDA) amended the labeling regulation for an authorized health claim on the relationship between calcium and a reduced risk of osteoporosis. The amendments do the following: add vitamin D and osteoporosis; eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and finally, allow reference for the need of physical activity in either of the health claims to be optional rather then required.
This rule can be viewed through the Federal Register.
FDA holds a meeting on advisory labeling of food allergens
The FDA held a public hearing on advisory labeling on the possible presence of allergens in foods. Currently, food manufacturers use over 30 different ways to label a food that “may contain” an allergen. FDA is concerned with the increase of recalls of food due to allergy contamination, mostly with peanuts. Consumer advocates contend that the advisory statements are confusing because there is no conformity with respect to the language used or the placement on the package. For example, packages of peanuts might carry the label “may contain peanuts”, whereas other packages might be labeled “Contains: No soy, no milk, no eggs,” while still others say “made in facility that uses an allergen”.
Industry groups contend that the 2000 statement of the Food Allergy Issues Alliance set out specific principles and criteria for the “may contain” language which are still pertinent, but admitted that there are many cases where companies, both large and small, have not followed these principles and have overused the advisory statements. Other groups have recommended that thresholds be established that permit a small presence of an allergen in the food without carrying an advisory statement. The industry cited the lack of accurate detection methods for some allergens in some food matrices, uncertainty of sampling protocol, a potential for an unexpected contamination with a significant amount of the allergen, and the additional liability that might arise with the judgment left with the food company.
For more information on food allergens and labeling, visit the FDA website.
ARS updates database of isoflavone compounds in foods
The USDA Agricultural Research Service (ARS) has updated the database of isoflavone compounds in foods. The new database provides analytical values for three individual isoflavone compounds—genistein, daidzein and glycitein—found in nearly 550 foods. These are grouped under 21 separate categories, such as "Legume Products," "Baked Products" and "Baby Foods." Researchers conducted an extensive review of various data sources and evaluated scientific articles published in peer-reviewed journals since 1999 to develop the database. All the data were evaluated by a data quality evaluation system developed by the Nutrient Data Laboratory scientists.
NATIONAL INITIATIVES
National Academies releases report on scientific appointments in a new Administration
A new report from the National Academies, Science and Technology for America's Progress: Ensuring the Best Presidential Appointments in the New Administration, provides suggestions on filling key science appointments after the election, including a list of 80 high-level science and technology (S&T) positions that serve crucial roles in advising the president on issues that range from health care to energy to economic growth. The report also urges scientists to serve in these positions and suggests ways to make such positions more attractive. The Committee that developed the report was led by former congressman and Chair of Research!America John Edward Porter and the report has been shared with the McCain-Palin and Obama-Biden campaigns.
- A confidential S&T advisor should be selected immediately after the election who will help identify and recruit the best candidates for key appointments, participate in budget decisions for fiscal years 2009 and 2010, and provide guidance in the event of a crisis.
- Following the inauguration, the aforementioned advisor should be appointed the assistant to the president for S&T and nominated as the director of the White House Office of Science and Technology Policy (OSTP).
- The OSTP Director should be included in cabinet discussions about the scientific and technological aspects of broader policy decisions.
- Scientific and professional societies should more actively reach out to the president's science adviser and other senior administration leaders to provide input that broadens the pool of candidates for appointments.
- The new president should ensure his administration makes the process for appointing people to federal advisory committees explicit and transparent, and ensure that those chosen to provide S&T expertise are selected solely for their knowledge, credentials, and professional and personal integrity.
FASEB launches web-based NIH advocacy clearinghouse
The Federation of American Societies for Experimental Biology (FASEB)'s Office of Public Affairs has created a new web site to serve as a clearinghouse of NIH advocacy materials. At www.nihadvocacy.org, visitors will find a one-stop shop where facts and figures can be located to assist in making the case for more funding for the agency. The site provides current and historical information on how much money the NIH receives, what it spends that money on and what the fruits of that spending have been. It also offers materials such as PowerPoint slides and fact sheets that advocates and scientists can use when communicating with lawmakers and their staff. Many organizations contributed materials to the website. Links are provided to NIH-developed materials and reports.
Trust for America's Health discusses F as in Fat
Trust for America's Health and the Robert Wood Johnson Foundation, who jointly released the 2008 volume of F as in Fat: How Obesity Rates are Failing America, briefed Congressional staff and the public on sections of the report. F as in Fat is a comprehensive look at the most recent numbers and trends in obesity rates across the United States. It provides a snapshot of state laws, school programs, private health insurance programs and menu labeling practices. The report also offers recommendations for a national strategy to combat obesity, including nutrition counseling. The report may be viewed in full on the Trust for America's Health website.