November 2003
ASPET Government and Public
Affairs
Congress Passes
Week-Long CR
Congress has passed a second continuing resolution
(CR) to keep many federal programs - including NIH in operation
through November 7. Conference negations on the Labor/HHS bill
that funds the NIH have stalled. Additional CRs are almost
certain along with the growing chance that all unfinished
appropriations bills will be rolled into one large omnibus bill.
ASPET’s “Explore
Pharmacology”
ASPET's new brochure
explaining what pharmacology is and how to pursue graduate study in
it, Explore Pharmacology, is now available as a PDF file on the
ASPET web site.
http://www.aspet.org/public/Explore%20Pharmacology.pdf
NIGMS
Publication: Medicines By Design
View NIGMS’ new
educational booklet about pharmacology, “Medicines by Design” at:
http://www.nigms.nih.gov/medbydesign/
NIMH
Presentation on Research on New Classes of Antidepressants
A video
presentation on the “Psychopharmacology of Mood Disorders: A
New Golden Era in the Making” by Dennis S. Charney, Chief of the
Mood and Anxiety Disorders Research Program at NIMH can be
viewed at
www.nimh.nih.gov/videos/goldenera.cfm. Dr. Charney’s talk
was part of the NIH’s Clinical Center 50th Anniversary
Scientific Symposium at the 2003 NIH Research Festival. Dr.
Charney presents an update of research on depression currently
underway, discussing leads to developing new classes of
antidepressants.
EB’04
(Washington, DC) Public Affairs Sessions
On Monday, April 19, ASPET’s Public Affairs Committee
is sponsoring a session on the “Scientific and Regulatory Challenges
Involving Dietary Supplements and Botanical Products.”
Confirmed speakers include: Marc McClellan, Commissioner, Food and
Drug Administration;
Paul Coates,
Director, Office of Dietary Supplements, NIH; and Stephen
Straus, Director, National Center for Complementary & Alternative
Medicine, NIH.
On
Tuesday, April 20, ASPET’s Public Affairs Committee is sponsoring a
session on “Sustaining
Integrative & Organ Systems Biology: Problems, Opportunities,
Solutions.” Confirmed speakers include: Jerry
Buccafusco, Medical College of Georgia; Gerald Schaefer, Wil
Research Laboratories, Inc.; Steve Zeisel, University of North
Carolina; Irv Zucker, University of Nebraska; other speakers to be
announced.
Details at:
www.aspet.org/public/meetings/eb04.html#special
Stem Cell
Research
The President’s
Council on Bioethics has prepared two staff documents regarding stem
cell research. Applications of Human Stem Cells in
Research and Medicine:
http://www.bioethics.gov/background/sc_application.html; and
Monitoring Stem Cell Research: The Ethical Debates Reviewed:
http://www.bioethics.gov/background/monitor_stem_cell.html
Dietary
Supplements Bibliography
The Office of Dietary Supplements at NIH has released the fourth
issue of the Annual Bibliography of Significant Advances in Dietary
Supplement Research. This publication presents significant research
in the dietary supplement field for 2002.
http://ods.od.nih.gov/publications/publications.html
NCCAM
Distinguished Lecture
On
October 22, Dr. Norman Farnsworth, Director of the Program for
Collaborative Research in the Pharmaceutical Sciences at the
University of Illinois at Chicago spoke on "Herbal Medicine: Ancient
Practice Meets Modern Science." To view the videocast of the
lecture, visit
http://videocast.nih.gov/ram/nccam102203.ram
(requires RealPlayer software).
October 2003
ASPET Government and Public Affairs Report
NIH
Appropriations
Resolving the
differences remaining in the FY’04 Labor/HHS bill that funds the NIH
may begin this week. The House and Senate have approved a
month-long continuing resolution that will fund programs through
October 31 (The fiscal year begins October 1). This
means NIH among other agencies will be funded at the FY’03 level for
the first month of FY’04. The House bill calls for a 2.5% increase
for the NIH budget for FY 2004 while the Senate bill proposes a 3.7%
increase. Efforts are still being made to increase the amount
beyond the Senate passed number for the NIH. Reps Lois Capps
(D-CA), Chris Bell (D-TX), Mark Foley (R-FL), and Jim Leach (R-IA)
have drafted a "Dear Colleague" letter from the House to the Labor-HHS
conferees calling for an 8-10% increase for NIH in the final
conference bill. In the Senate, Susan Collins (R-ME) and
Dianne Feinstein (D-CA) have drafted a Senate "Dear Colleague"
asking the Labor-HHS conferees to provide "the highest possible
funding level for NIH" in FY2004. ASPET members are urged to
contact their Representatives and Senators to sign these letters.
Copies of the letters and lists of the Representatives and Senators
who have signed the letters are attached. To reach your
Representative and Senators, call the U.S. Capitol switchboard at
202-224-3121.
Botanical
Research
Larry A. Walker,
Ph.D., director of the National Center for Natural Products
Research, School of Pharmacy at the University of Mississippi has
been appointed to serve on the advisory council for the NIH’s
National Center for Complementary and Alternative Medicine (NCCAM).
NCCAM’s Advisory
Council approved September 8 a research initiative for Botanical
Research Centers Programs:
http://nccam.nih.gov/research/concepts/consider/botresearch.htm
NCCAM, the
Office of Dietary Supplements (ODS), and the National Institute of
Environmental Health Sciences (NIEHS) convened an expert panel in
February 2003 to review the jointly funded Botanical Research
Centers Program. This report summarizes the panel's findings and
recommendations.
http://nccam.nih.gov/training/centers/bot_research.htm
Other
Research Funding
RFA-MH-04-001.
Pharmocogenomics of Mood and Anxiety Disorders
http://grants1.nih.gov/grants/guide/rfa-files/rfa-mh-04-001.html
AAALAC
Activity Report
A report on the
2002-2003 activities of the Association for Assessment and
Accreditation of Laboratory Animal Care International (AAALAC) can
be read at
FASEB
Communicates Value of Basic Research
The Science
Policy Committee of FASEB plans to develop an expanded website with
detailed scientific explanations and additional examples
demonstrating the numerous ways that DNA and genetic research
contribute to our science and to our everyday lives. If you
are interested in hearing more about this initiative, please contact
FASEB Science Policy Analyst, Carrie Golash at tel: 301-634-7650;
email: cgolash@opa.faseb.org.
September 2003
ASPET Government and Public
Affairs
Urgent - ASPET Members Needed to Support X-Tra
$1.5B to FY’04 NIH Budget--Contact Your Senate Offices Today
The full Senate is expected to begin consideration of the FY’04
Labor-HHS-Education appropriations bill shortly after returning to
Washington on September 2. The Senate bill (as approved
by the Senate Appropriations Committee provides the NIH $27.982, a
$1 billion or 3.7% increase above FY’03. Labor-HHS Chair Arlen
Specter (R-PA), Ranking Member Tom Harkin (D-IA), and Senator Diane
Feinstein (D-CA) will offer an amendment during Senate floor
consideration of the bill to increase NIH funding by an additional
$1.5 billion for a total increase of $2.5 billion, or 9.2% over
FY’03.
Because of spending cap requirements imposed by the FY’04 budget
resolution, the amendment will require 60 votes to pass. So it
is especially important that you contact your Senate offices now.
We are asking all ASPET members to contact their Senators and urge
them to “support the Specter-Harkin amendment to increase NIH
funding by an additional $1.5 billion.” Call the U.S. Capitol
Switchboard at 202-224-3121 and they will connect you to your Senate
offices. Simply leave your name, affiliation along with your
message.
FASEB
Consensus Conference
ASPET President David Bylund (Univ Nebraska Medical Center) and
Council Member Kim Neve (VA Medical Center, Portland, OR) will
represent ASPET at the FY 2005 FASEB Consensus Conference for
Federal Research Funding. The annual consensus conference
makes budget recommendations for the NIH, NSF, VA, USDA, DOE, and
NASA. Dr. Bylund will serve on the NIH subcommittee; Dr. Neve
will serve on the VA subcommittee. The final recommendations,
approved by FASEB’s Board, serve
as basis for testimony before Congressional
appropriations committees
National Academy Study Recommends Changes for NIH
The National Academy of Sciences recommends several organizational
changes at the NIH including, merging of some institutes with
similar mandates, devoting more of each institute’s budgets towards
conducting translational research across NIH institutes, and a
review of the “One HHS” initiative that would outsource personnel
recruitment and grant management . To view the NAS report hit:
http://search.nap.edu/books/0309089670/html/
Funding Opportunities and Other News
Request for
Applications
RFA-MH-04-004.
Translational Approaches in Bipolar Disorder Research
http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-04-004.html
Creation of New
Neurons Critical to Antidepressant Action in Mice
http://www.nimh.nih.gov/events/prneurogenesis.cfm
NIGMS Appoints
New Director, Jeremy H. Berg
http://www.nigms.nih.gov/news/releases/berg.html
USP
Comments on GMP
The United
States Pharmacopeia (USP) commended the Food and Drug
Administration’s efforts in issuing proposed rules covering current
good manufacturing practices (cGMP) for the manufacturing and
packaging of dietary ingredients and dietary supplements. USP
believes the proposed rules are a step forward for the dietary
supplement industry and when final should help ensure the quality
and safety of dietary supplements.
USP’s comments focus on scientifically
valid procedures, reference materials, dissolution and
disintegration, expiration dating, testing, and labeling. See
the pdf file for USP’s official comment letter.
July-August 2003
ASPET Government and Public
Affairs
EB’04
Public Affairs Sessions
Steve Straus,
Director of NIH’s National Center for Complementary Medicine, and
Paul Coates, Director of NIH’s Office of Dietary Supplements have
confirmed their participation in ASPET’s Public Affairs Workshop
(cosponsored by ASNS) on the “Scientific and Regulatory Challenges
Involving Dietary Supplements and Botanical Products.” The
workshop will be held on April 19 at 12:30 p.m at the Washington
Convention Center. FDA Commissioner Marc McClellan has been
invited to speak. The goals of the workshop are to promote
discussion about the need to promote a stronger scientific
foundation at FDA, how collaborations with NIH will help to improve
our understanding of the underlying mechanisms of action and help to
improve safety and efficacy of these dietary supplements and
botanicals, and the potential for reform of the 1996 Dietary
Supplement Health and Education Act (DSHEA) that freed botanical
dietary supplements from federal regulation.
ASPET’s
public affairs committee is also planning a workshop on April 20 in
support of systems and integrative pharmacology and biology.
Congress
Investigates Ephedra Products, Weighs Regulation
The House
Energy and Commerce Subcommittee on Oversight and Investigations
held two days of hearings concerning safety and regulatory issues
involving ephedra-containing dietary supplements. Committee
Chair Billy Tauzin (R-LA) and Subcommittee Chair, Rep. James
Greenwood (R-PA) suggested that Congress would not act until it
becomes clear how the FDA might exercise some authority under DSHEA.
FDA Commissioner Marc McClellan said that FDA would consider a ban
on ephedrine products. You can read selected testimony given
by FDA Commissioner McClellan, Drs. Ray Woosley, Douglas Zipes, and
Stephen Heymsfield below. Additional testimony can be found
at:
http://energycommerce.house.gov/108/Hearings/07232003hearing1021/hearing.htm
http://energycommerce.house.gov/108/Hearings/07242003hearing1036/McClellan1665.htm
http://energycommerce.house.gov/108/Hearings/07232003hearing1021/Woosley1630.htm
http://energycommerce.house.gov/108/Hearings/07232003hearing1021/Zipes1631.htm
http://energycommerce.house.gov/108/Hearings/07232003hearing1021/Heymsfield1629.htm
AAMC
Briefs on NIH Outsourcing and Consolidation
Two
NIH related issues are of interest to the biomedical research
community. Attached are two word documents, 1) OMB Circular
A-76 and the "commercial sourcing" of various NIH functions and 2) a
brief that relates to NIH consolidations and the DHHS "One
Department" Initiative. These documents were prepared by Tony
Mazzaschi of the Association of American Medical Colleges.
NABR Animal
Research Policy Summary
The National
Association for Biomedical Research (NABR) has released their 2003
Animal Research Policy Summary. The summary provides a brief
regulatory, legal, and legislative overview of current animal use
issues.
Commentary: Justification for NIH Funding Increases
A commentary
written by Bill Brinkley, Ph.D., and Robert Wells, Ph.D., published
in The Houston Chronicle states, "The current plan to
increase the 2004 NIH budget by between 2.5 percent (the Bush
administration's proposal and House's plan) and 3.7 percent (the
Senate's plan) could stop the scientific momentum that promises to
result in treatments for some of the world's greatest killers."
Dr. Brinkley is dean of the Graduate School of Biomedical Sciences
at Baylor College of Medicine. Dr. Wells is director of the Center
for Genome Research at The Institute of Bioscience and Technology,
Texas A&M University Health Science Center in Houston, and president
of the Federation of American Societies for Experimental Biology.
Their article may be read online at
http://www.chron.com/cs/CDA/story.hts/editorial/outlook/2000070
June 2003
ASPET Government and Public
Affairs Report
Experimental Biology ’04 Public Affairs Workshops
ASPET is
coordinating a pair of timely workshops that address topical issues
of interest to pharmacologists.
On Monday,
April 19, ASPET together with the American Society for Nutritional
Sciences is sponsoring a workshop titled:
Scientific and Regulatory Challenges Involving Dietary
Supplements and Botanical Products.
Rudolph Juliano
(University of North Carolina) will co-chair the session.
Topics to be addressed include: how to promote a stronger scientific
foundation at the FDA and the need to promote better health through
better research; how new collaborations with NIH will help to
improve our understanding of the underlying mechanisms of action and
help to improve safety and efficacy of these products; regulatory
perspectives on the Dietary Supplement Health & Education Act of
1994 (DSHEA); and opportunities for the extramural community.
Speakers to be announced.
On Tuesday,
April 20 ASPET will sponsor a workshop on systems and integrative
biology. Co-sponsors include the American Association of
Anatomists and the American Society for Nutritional Sciences.
ASPET President-elect David B. Bylund (University of Nebraska) will
Chair the session. The program will include a brief overview
of the missed opportunities and research potential in this neglected
area of research. Jerry Buccafusco (Medical College of
Georgia) will represent pharmacology, Jerry Schaefer (Wil Research
Laboratories, Inc.) will represent safety pharmacology and
toxicology, and Steve Zeisel (University of North Carolina) will
represent ASNS. Industrial representative will be included
too. Other speakers to be announced.
Each workshop
will begin at 12:30 p.m. and run for ninety minutes.
Dietary
Supplements
Members
of Congress that have sponsored legislation related to the
regulation of dietary supplements and ephedrine related products
have received copies of the ASPET position statement on dietary
supplements.
NIH
Solicits Mouse Sharing Public Comments
The NIH released
for public comment a draft statement on sharing and distributing
genetically modified mice and other "mouse resources."
The draft notice says that mouse resources are increasingly
expensive, time-consuming to develop, and are a significant
investment of public funds. The goal of the NIH is to develop
a policy that disseminates and shares mouse resources among academic
investigators that will help to expedite the translation of research
for better health.
View and
submit your comments at:
http://www.nih.gov/science/models/mouse/sharing/index.html
ASPET Comments
to NCRR Strategic Plan
NIH’s National
Center for Research Resources (NCRR) sought input from the research
community to their strategic plan. They are seeking to
identify barriers to future research progress and to help define the
future needs for shared research resources and technologies that
support NIH supported biomedical research. The NCRR is seeking
input from the research community to three questions: 1) what
are the most important research trends that will drive biomedical
research? 2) what research resources and technologies will be
critical in addressing these trends and meeting biomedical
investigators’ needs? and 3) what strategies will eliminate barriers
to progress and enhance access to research resources and
technologies? ASPET’s comments can be read at:
http://www.aspet.org/public/public_affairs/pa_NCRR_stratplan.htm
NIDA
Fellowship Programs
The
International Program at the National Institute on Drug Abuse is
offering Fellowships and scientific exchange programs to increase
opportunities for collaboration between NIDA-supported researchers
and their colleagues in other countries. For details on the
Invest Research Fellowship, the Distinguished International
Scientist Collaboration Program Award, and the NIDA Hubert H.
Humphrey Drug Abuse Research Fellowship view:
Http://www.drugabuse.gov/about/organization/International/Fellows.html
Pharmacology International
Pharmacology
International
the IUPHAR newsletter is now available online. To read it,
visit
http://www.iuphar.org/pi.htm
ASPET-
Merck Postgraduate Fellowships in Integrative Pharmacology
The ASPET- Merck
Postgraduate Fellowships in Integrative Pharmacology are renewing
the competition for 2003. One award will be made in each of
the following areas of research: behavior/neuropharmacology,
metabolism, and imaging. For additional, updated details on
eligibility visit
www.aspet.org/public/merck_fellowships/guidelines.html.
May 2003
ASPET Government and Public Affairs Report
ASPET-
Merck Postgraduate Fellowships in Integrative Pharmacology
The ASPET- Merck
Postgraduate Fellowships in Integrative Pharmacology are renewing
the competition for 2003. One award will be made in each of
the following areas of research: behavior/neuropharmacology,
metabolism, and imaging. For additional details on eligibility
visit
www.aspet.org/public/merck_fellowships/guidelines.html.
ASPET
Testimony Supports FY’04 NIH Budget of $30.06 billion
View ASPET’s
written testimony to the House Labor/HHS Appropriations Subcommittee
at
www.aspet.org/public/public_affairs/pa_nih_fy04_support.html.
ASPET
Statement on Dietary Supplements
ASPET’s
statement on dietary supplements calls for regulations and
legislation to amend the Federal Food and Cosmetic Act establishing
labeling, advertising, and restriction of sales of dietary
supplements containing ephedrine. View the ASPET position
statement at
www.aspet.org/public/public_affairs/pa_dietary_supp.html.
VISA Issues
The new U.S.
Visitor and Immigrant Status Indicator Technology (VISIT) system
that presumes a "virtual border" of mandatory interviews with
consulate officers could mean significant delays for visa
application approvals for foreign researchers and students.
Department of Homeland Security (DHS) Undersecretary Asa Hutchinson
said VISIT is the DHS response to a congressional mandate calling
for an entry-exit system to be installed at America's airports and
seaports by the end of the year. $400 million in FY 2003 has been
appropriated to implement the system. "We will eventually have
information on our visitors -- collected at our consular officers
far from our borders -- that will confirm identity, measure security
risks and assess the legitimacy of travel of visitors to the U.S.,"
said Hutchinson. He noted that initial biometric identifiers
that include fingerprints and photographs. As technology
improves, additional forms such as facial recognition or iris scans
may be added. As information increases, the Office of
Compliance will grow the capability to track the cases and refer
them, when appropriate, for investigation. The information would be
made available to inspectors, agents, consular officials "and others
with a true need to know." It is expected the VISIT system
will be implemented incrementally over the next two years and will
be used in conjunction with the department's foreign student
tracking system, known as the Student and Exchange Visitor
Information System (SEVIS).
A detailed fact
sheet on the VISIT system <http://www.dhs.gov/dhspublic/display?content=736>
is available at
www.dhs.gov/dhspublic/display?content=736
View Secretary
Hutchinson’s statement at
www.dhs.gov/dhspublic/interapp/speech/speech_0114.xml.
Funding Opportunities
NIGMS has re-announced its Centers of Excellence in
Complex Biomedical Systems Research program.
These centers will perform innovative research and training focused
on quantitative, systems-level analysis of biological phenomena of
biomedical importance within the NIGMS mission.
Centers of Excellence in Complex Biomedical Systems
Research RFA GM-03-009
http://grants1.nih.gov/grants/guide/rfa-files/RFA-GM-03-009.html
NIGMS is a
co-sponsor of the following new and re-announced funding
opportunity:
Integrative and
Collaborative Approaches to Research PA-03-127
http://grants1.nih.gov/grants/guide/pa-files/PA-03-127.html
NCI
MAbs
For Scientists
interested in drug metabolism, reduction of adverse drug reactions,
and drug discovery, the National Cancer Institute of the National
Institutes of Health is making available specific inhibitory
monoclonal antibodies (MAbs) to human cytochromes P450 1A1, 1A2,
2A6, 2B6, 2C8, 2C9, 2C19, 2C family, 3A4/5, and 2E1. Requests
for specific MAbs and the Material Transfer Agreement should be sent
to Patrick Twomey, Ph.D., Technology Transfer Branch (e-mail:
twomeyp@mail.nih.gov). Requests for larger amounts of the MAbs can
be obtained by license through Fatima Sayyid, M.H.P.M., Office of
Technology Transfer (e-mail: sayyidt@ot.nih.gov).
New Brochure on
Primate Research
The consortium of
the eight National Primate Research Centers has produced a new
publication supporting the use of nonhuman primates in lifesaving
research. Entitled "Linking Research to Healthy Living," it
may be downloaded
here. Printed copies are available through the National Primate
Research Center nearest you. For locations,
click here.
National Science Foundation
ASPET members with
an interest in funding for the National Science Foundation are asked
to contact their Representative in Congress to endorse a Dear
Colleague letter urging House Veterans Affairs, Housing and Urban
Development and Independent Agencies (VA-HUD) subcommittee Chairman
James Walsh (R-NY) and Ranking Member Alan Mollohan (D-WV) to
appropriate $6.39 billion for the NSF in FY’04. This funding level
would be the first installment towards doubling the agency's budget
by FY 2007. The deadline for signatures on this letter is soon so
email your letter to your Representative today. For additional
information, use the Research!America link below to access their
advocacy site.
http://capwiz.com/ram/mail/oneclick_compose/?alertid=2220331.
April 2003
ASPET Government and Public
Affairs
EB Meeting
ASPET’s public
affairs committee met at EB and will begin to plan workshops for
EB’04 on systems and integrative biology and dietary supplements.
EB’04 will be held in Washington, DC from April 17-21.
ASPET-Merck Postdoctoral Fellowships in Integrative Pharmacology
The ASPET-Merck
Postdoctoral Fellowships in Integrative Pharmacology have renewed
the competition for postdoctoral fellowships in integrative
pharmacology. Please visit the ASPET web site at
www.aspet.org in the next couple of weeks for application
details and information. An advertisement of the awards can be
viewed in the attached pdf file. Application deadline is
September 1, 2003.
Foreign
Student Visas
Academic
representatives testified before the House Science Committee over
visa problems facing foreign students and its impact on U.S.
universities and U.S. security. Committee Chairman Sherwood Boehlert
(R-NY) and Ranking Democrat Ralph Hall (D-TX) have asked the General
Accounting Office (GAO) to provide data on the extent and nature of
the visa backlog. Several Members of the Committee raised
questions about why the U.S. was so dependent on foreign students.
But Boehlert said, "The visa problem is sometimes discussed as
simply a problem for our universities that needs to be balanced
against the need for security. But that's a distorted view.
The reason for concern is that unnecessarily impeding the flow of
students and scholars in and of itself can erode our national
security." For additional information see the Committee web
page at
www.house.gov/science.
NCRR Strategic Plan Open for Comments
NCRR stakeholders
have an opportunity to offer suggestions for its revision of the
NCRR Strategic Plan. Comments are due by May 15, and are submitted
electronically. As part of ASPET’s initiatives in systems and
integrative biology, ASPET members could incorporate the need for
NCRR to enhance training opportunities in integrative, in vivo
pharmacology and biology. Also, The National Primate Research Center
Directors have produced talking points (see word attachment) that
you might want to consider in your response. See NCRR
strategic plan guidelines at
http://www.ncrr.nih.gov/sprecommend.asp
News From NIDA
"Foundations and
Innovations in the Neuroscience of Addiction," a two-day symposium
dedicated to the memory of Dr. Roger Brown, will be held at Natcher
Auditorium in NIH's main campus, May 14 -15, 2003. For additional
details on this conference go to,
http://www.masimax.com/foundationsandinnovations/index.htm
View NIDA Notes
publications at
http://www.drugabuse.gov/NIDA_Notes/NNIndex.html
AAMC Testifies on Development of WMD Medical Education
Programs
The AAMC
testified before the
House Veterans' Affairs Subcommittee on Oversight and
Investigations
about the progress
medical schools and teaching hospitals are making to
integrate
information on responses to biological, chemical and radiological
events into medical education. Additional information is at:
http://www.aamc.org/advocacy/library/washhigh/2003/041103/_2.htm
FASEB
FASEB's
Breakthroughs in Bioscience series: "Genetic Research: Mining for
Medical Treasures," is available online at:
http://www.faseb.org/opar/break/genetic.pdf.
Frederick
Rickles will be the new executive director of the Federation of
American Societies for Experimental Biology (FASEB). Rickles
currently serves as associate vice president for health research,
compliance and technology transfer at the George Washington
University medical center. From 1993-1998 he was the deputy chief of
hematologic diseases at the Centers for Disease Control and
Prevention as well as professor of medicine and pediatrics at Emory
University in Atlanta. He is a former director of the Thrombosis
Research Laboratory at Walter Reed Army Institute of Research.
A member of the American Society of Hematology, the American Heart
Association and the American Association of Immunologists, Rickles
has served on several study sections at the National Institutes of
Health and the Department of Defense, as well as the American Cancer
Society and the American Heart Association.
March 2003
ASPET Government and Public
Affairs Report to
Council and Public Affairs
Committee
EB’03 Meeting Public Affairs Events
A
number of public affair events will be of interest to members
attending the ASPET Annual Meeting at EB:
ASPET will be presenting an overview of ASPET’s systems and
integrative pharmacology/biology advocacy initiative to the American
Association of Anatomists Public Affairs Committee meeting on
Saturday, April 12 from 1:00-3:00 p.m. in room 24 A/B of the
convention center. The AAA public affairs meeting is open to all EB
attendees.
NIH Director Elias Zerhouni is speaking at a session of the American
Society for Biochemistry and Molecular Biology on Sunday, April 13
at 8:30 a.m. in room 20 D of the convention center. The title
of his talk is “A New Vision for the NIH.”
On
Friday, April 11 from 1:00 – 5:00 p.m., the annual “IACUC 101 for
Scientists” will be held in room 7A of the convention center.
Also on April are sessions on “Science and the Media” from 2-5pm in
room 11B of the convention center and “Human Research Subject
Protections: How to Navigate Human Subject Protection Regulations,”
from 3-5pm in room 15 A of the convention center.
NIH FY’04 Budget
The President's proposed tax
cuts and a list of controversial spending cuts that would never pass
congress were debated in the House and Senate the week of March 17
in the FY’04 budget resolutions. War with Iraq and large tax
cuts are bad news for many domestic discretionary spending programs.
The budget deliberations signal the opening shots of what will be a
difficult and unsteady year in achieving the biomedical research
community’s recommended 10% increase for the NIH.
The House budget
resolution calls for a 1.3% increase in FY 2004. However, because
defense and homeland security are given significant increases, there
is a 1 percent spending reduction in most discretionary programs.
For budget function 550 (health), the House budget resolution
assumes a 2.8% cut from the FY 2003 level. The committee report
states the budget assumes $27.9 billion for the NIH in FY 2003,
short of the $30 billion total the biomedical research community is
advocating.
Depending on your
perspective, the numbers are a little better or not quite so bad, in
the Senate budget resolution calling for a 2.4% increase in overall
discretionary spending and for a 0.3% increase in budget function
550. The Senate budget resolution also assumes $27.9 billion for NIH
in FY’04.
The House begins
floor consideration of the budget resolution on Thursday, March 20.
The Senate began its floor debate on the resolution on March 17 with
an expected vote on final passage the week of March 24. It is
important that Members of Congress hear from members of the
scientific community to provide sufficient funding for the NIH.
Call or fax your Senators and Representatives and make the following
points: 1) express your concern that the FY 2004 budget resolution
does not contain sufficient funding for the National Institutes of
Health in budget function 550 (health) that would help maintain
funding for critical biomedical research; 2) note that it is
essential that support for medical research be sustained so that the
gains made in the past five years are not eroded; and 3) remind
congress that the research community is advocating for a 10%
increase in the FY’04 budget for the NIH and that you hope the
bipartisan momentum over the past five years continues. You
can access contact fax and email information for your elected
officials by hitting the following links:
www.senate.gov
www.house.gov
AAALAC Conference
"Trends and
Expectations: The AAALAC Conference on Quality Laboratory
Animal Care,"
will be held May 19 - 20 in Reston, Virginia. The
registration deadline is April 4. This conference is offered
only once every four years. Space is limited, so reserve your spot
by registering online at
http://www.aaalac.org/conference.htm or call 301-231-5353.
NABR Note
The National
Association for Biomedical Research has also learned that The Humane
Society of the United States (HSUS) is distributing a letter to
biomedical research facilities requesting a copy of their
institutional annual reports that are submitted to the Department of
Agriculture (USDA - Form 7023) and related documents including
information regarding exemptions from the Animal Welfare Act and
Column E procedures for the years 1999 - 2002. If you receive the
HSUS letter, before responding, NABR requests that you refer it to
the attention of your general counsel and then contact NABR
Executive Vice President Mary Hanley at 202-857-0540.
USP Names New Leader For R&D Laboratory
Dr. Gary Allmaier has been appointed director of the USP’s
Research & Development Laboratory (RDL). USP's RDL conducts
analytical development and other activities in support of official
USP Reference Standards. These reference standards are used to
assess the strength, quality, and purity of drugs, including
biologics, dietary supplements, and healthcare devices.
As the new director of RDL, Allmaier will provide leadership for the
laboratory and advance its initiatives to support the development of
new analytical methods for USP monographs and reference standards.
Allmaier also will strengthen the lab's role in supporting the
growth of USP's new Dietary Supplement Verification Program (DSVP).
Dr. Allmaier comes to USP from Bristol-Myers Squibb where he was
responsible for managing the development of several novel drugs from
discovery to new drug approval. Prior to this role, Dr.
Allmaier spent 22 years in the pharmaceutical industry as an
analytical research and development manager and chemist.
February 2003
ASPET Government and Public
Affairs
NIH Funding
Funding for
FY’03 remains in doubt. On February 5, Congress passed another
continuing resolution (CR) through February 20 that allows federal
programs to operate at FY’02 levels. Congress is attempting to
finish the appropriations bills by Presidents Day and is threatening
a year long CR at FY 2002 levels if congressional conferees cannot
settle the differences between the House and Senate bills.
Conferees were scheduled to meet on February 10 to finalize the
package. There now seems to be an across-the-board of less than 1%
to allow for priority funding of Medicare and education. The
Administration is also threatening a veto if the final bill is not
held below the limit set ($755b) by the President. There are also
contentious provisions related to homeland security and abortion.
A year long CR would be a worse case scenario for NIH grantees.
There still remains a good chance that money will be “found” and the
bipartisan support for NIH will help insure that the agency meets
its doubling goals. But the longer this impasse continues the
less likely a favorable outcome might result.
Meanwhile, the
details on the President’s FY04 NIH Request have been released.
The President’s budget requests a 2.0% or $549 million increase for
NIH above the assumed FY03 base of $27.3 billion. The
Administration base for FY03 new grants is approximately 10,050.
The FY04 number for new grants will be approximately 10,140.
Non bioterror grants will fall from FY03’s approximate 9720 to
FY04’s 9490. Bioterror grants will rise from FY03’s approximate 330
to FY04’s 665. Continuations will increase by 1%.
Training stipends will rise by 4%.
The Bush budget
proposal converts approximately $1.4 billion from FY 2003
appropriations for facilities construction and anthrax vaccine
procurement in order to increase research programs in FY 2004.
This accounting method allows HHS to maintain the real increase in
the research budget for FY’04 is 7.5%, although non-biodefense
research will only rise about 4%.
Reminder once again, these figures assume resolution of the
FY’03 budget at $27.3 billion.
View the FY 2004
Congressional Justification of the NIH budget proposal at:
http://www4.od.nih.gov/officeofbudget/requestFY2004.html
New NIDA Director Named
NIH Director Elias
A. Zerhouni recently announced the appointment of Nora D. Volkow,
M.D., as the new director of the National Institute on Drug Abuse (NIDA).
Dr. Volkow is currently Associate Director for Life Sciences at
Brookhaven National Laboratory (BNL), Director of Nuclear Medicine
at BNL, and Director of the NIDA-DOE Regional Neuroimaging Center at
BNL. She is also Professor at the Department of Psychiatry, SUNY-Stony
Brook, and Associate Dean for the Medical School at SUNY-Stony
Brook. Dr. Volkow will assume her position in mid-April.
Details at
http://www.drugabuse.gov/Newsroom/03/NR1-23.html.
NCCAM Names First Deputy Director
The National Center
for Complementary and Alternative Medicine (NCCAM) has announced the
appointment of Margaret A. Chesney, Ph.D., as its first Deputy
Director. As NCCAM's first Deputy Director, Dr. Chesney will partner
with NCCAM Director Stephen Straus in planning, directing, and
managing the programs and resources of the Center. In this capacity,
she will help formulate, guide, and oversee the management of all
NCCAM-funded extramural centers, investigator-initiated research,
research contracts, fellowships, and training and career awards --
totaling over $86 million in investments in Fiscal Year 2002.
Prior to joining
NCCAM, Dr. Chesney was professor of medicine and epidemiology at the
School of Medicine, University of California, San Francisco (UCSF),
where she was co-director of the Center for AIDS Prevention Studies
and director of the behavioral medicine and epidemiology
core of the UCSF
Center for AIDS Research. Most recently, she was also a senior
visiting scientist in the NIH Office of Women's Health, in the
Office of the Director. In 2001 she was elected to the
Institute of Medicine of the National Academies of Science.
EB IACUC Symposium
A half-day
symposium on the workings of the IACUC will be offered to scientists
who attend Experimental Biology 2003 in San Diego. "IACUC 101
for Scientists" will be presented from 1-5 pm on Friday, April 11 in
Room 7A on the upper level of the San Diego Convention Center "IACUC
101 for Scientists" is intended to address the concerns of research
scientists and will provide information useful both to IACUC members
and to those whose protocols require IACUC review. Sponsored
by EB 2003 with support from the NIH Office of Laboratory Animal
Welfare, American Association of Anatomists, American Physiological
Society, American Society for Investigative Pathology, American
Society for Nutritional Sciences, American Society for Pharmacology
and Experimental Therapeutics, and the Federation of American
Societies for Experimental Biology. You must be registered for
the Experimental Biology meeting to participate, but there is no
separate fee for this session although registration is suggested at:
http://grants1.nih.gov/grants/olaw/eb2003.htm. For
information, contact
Alice Ra'anan at (301) 634-7105 or
araanan@the-aps.org.
FASEB Consensus
Conference Report
FASEB’s annual
consensus conference report, "Federal Funding for Biomedical and
Related Life Sciences Research" recommends an FY 2004 budget
increase of 10% for NIH over the Administration's FY 2003 $27.3
billion request to ensure the progress achieved by the five-year
campaign to double the agency's budget will continue.
FASEB’s report
also calls for specific funding levels for other federal agencies
and programs engaging in R&D. For the National Science Foundation,
FASEB recommends an FY 2004 appropriation of $6.39 billion, an
amount consistent with efforts to double that agency's budget by
2007. The level also would allow an increase in average grant size
and duration. Both, FASEB said, are needed. NSF funding in FY 2002
was $4.8 billion, and the FY 2003 request is for $5.0 billion.
To support research through the Department of Energy, FASEB
recommends an appropriation of $4.015 billion for DoE's Office of
Science in FY 2004, a total that would increase the office's budget
from the FY 2002 level of $3.28 billion. The FY 2003 request is a
0.4% increase over the previous year. FASEB also recommends
providing $460 million in FY 2004 for biomedical research at the
Department of Veterans Affairs, $240 million for the Department of
Agriculture's National Research Initiative Competitive Grants
Program, and $925 million for NASA's Office of Biological and
Physical Research. View the consensus conference at:
http://www.faseb.org/opar/fund2004/fedfund04.pdf.
January 2003
ASPET Government and Public
Affairs
National
Institutes of Health ’03 Funding Situation-Member Action Needed
As you are
aware, the 107th Congress adjourned last November without
passing almost all appropriation bills for FY’03, including the
Labor/HHS bill that funds the NIH. With the start of the
108th Congress, the Chair of the House Labor/HHS
subcommittee (Ralph Regula, R-OH) introduced on January 8 a FY’03
Labor/HHS bill that provides $26.6 billion for the NIH, an increase
of 14% over FY’02 levels. The bill funds the lead agency on
biodefense research, NIAID, at $2.67 billion, an increase of $146
million over FY’02 2002, but $1.269 billion below the President's
request. The House bill creates a $2.24 billion discretionary
reserve fund for the NIH Director to allocate to institutes and
centers to "support the highest priority research and infrastructure
needs in bioterrorism, but also in other non-bioterrorism research
areas." Funding for other NIH institutes, centers and
divisions are at funding levels that would support ongoing research
project grants at their committed levels in FY 2003, and funds other
mechanisms (e.g. centers, training, intramural research and research
management and support) at FY 2002 levels with the expectation that
the director would provide from the reserve fund for pressing
research needs beyond those levels. It remains unclear if the
designated discretionary funds in the NIH directors’s office will
remain in whatever the final spending bill looks like.
At this point it is
not clear what may happen next or how the process will move forward.
The House also passed two continuing resolutions (CR). One CR
will keep the government running through January 31 at the current
FY02 rate. The second
CR is to be used
as a vehicle by the Senate to help pass their 11unfinished spending
bills. If the Senate can mark up its spending package in time,
that omnibus bill would be added to the second CR, which would go to
a House-Senate conference committee. Given the political and fiscal
restraints on spending, the outlook for NIH remains very positive,
with the proposed House bill just about at the doubling (15%) level
the research community has advocated for. GOP leaders hope
these bills will be resolved by the President’s State of the Union
Address on January 28.
But the positive
news to date might turn south and these gains could be reversed.
The danger remains that in attempting to complete the FY03
appropriations process as quickly as possible, Congress may resort
to lower spending levels that put the NIH doubling at risk. If
Congress fails to act, NIH will be funded for the year at last
year's levels. If NIH is funded at the current FY2002 level
for the rest of this year: 1) new grants will be cut from a
projected 9800 to approximately 6600 awards, and 2) the NIH-wide
success rate will drop from the current 32% to 20-22%.
Both FASEB and
AAMC have issued alerts, along with other research and patient
groups to make certain Congress stays on track with the doubling
effort. ASPET members are urged to contact (by fax or phone)
their respective Senators and Representatives as soon as possible to
urge quick completion of the NIH doubling effort. A brief
one-page letter or phone call to congressional offices should state
the importance of funding the NIH adequately and should also
emphasize how not meeting the bipartisan doubling effort will impact
the progress on needed research that will lead to improved therapies
and cures for Americans. Contact the Capitol Switchboard at
202-224-3121 to place your call directly to your Congressional
office. Leave a message or ask for a fax number to write your
letter. With Republican control of both the House and Senate,
it is especially important that Republicans, particularly leadership
hear from their constituents. They will be under pressure to
hold spending levels in line with the President’s budget.
House Republican leaders include: Dennis Hastert (IL), Tom
Delay (TX), Roy Blunt (MO), Deborah Pryce (OH), Bill Young (FL), and
Jim Nussle (Iowa). Senate Republican leaders include: William
Frist (TN), Don Nickles (OK), Ted Stevens (AK), Mitch McConnell (KY)
PRAT Program
Awards Highlighted
An article of
interest to ASPET members regarding the PRAT postdoctoral program
appeared in a recent issue of the NIH Record. To access, click
www.nih.gov/news/NIH-Record/12_10_2002/story03.htm
Announcing Postdoctoral
Fellowship in Developmental Neurotoxicology National Center for
Toxicological Research
Postdoctoral Position $45,000+/year. Neuroscience, Toxicology
/Pharmacology, Developmental Neurotoxicology: A postdoctoral
position is available in the Division of Neurotoxicology at the
National Centerfor Toxicological Research (NCTR), Food and Drug
Administration (FDA), Department of Health and Human Services (DHHS).
This is an appointment with the Oak Ridge Institute for Science and
Education (ORISE), not a federal government appointment.
A groundbreaking study concerning the developmental effects of the
noncompetitive NMDA antagonist, ketamine, is the primary focus of
the work. This large study will be the first to determine if the
dissociative anesthetic, ketamine, will induce abnormal levels of
neuronal apoptosis in the developing nonhuman primate. Where
possible, the relationship of specific neuronal loss to
physiological processes and functions will be addressed.
Longitudinal, noninvasive MicroPET imaging, quantitative behavioral
assessments of cognitive function and differential gene/protein
expression will also be assessed as warranted.
U.S. citizenship is not required, but the appropriate visa must be
obtained before employment. Candidates must have a Ph.D. with
an emphasis on pharmacology, toxicology and/or neuroscience.
Experience with approaches to monitoring programmed cell death and
with nonhuman primates is also highly desirable. Anticipated salary
will be $45,000+/year. Applications (CV, a brief statement of
research interests and the names and contact information for 3
references) should be submitted as soon as possible. The
starting date is early 2003; however, the position will remain open
until filled. For more information contact: William Slikker,
Jr., Ph.D., Director, Division of Neurotoxicology, 3900 NCTR Road,
Jefferson, Arkansas 72079; phone: 870-543-7203; e-mail: wslikker@nctr.fda.gov
NCCAM Centers
The National Center
for Complementary and Alternative Medicine's (NCCAM) new Centers for
Research on Complementary and Alternative Medicine Program. This
initiative will establish three companion programs: Centers of
Excellence for Research on CAM, Developmental Centers for Research
on CAM, and Planning Grants for International Centers for Research
on CAM. Links to the requests for applications and program
announcements for these opportunities are available at
www.nccam.nih.gov . These programs are designed to enlist
researchers from multiple disciplines--both conventional and CAM--to
advance complementary and alternative medicine research.
Please share this e-mail with your colleagues who might be
interested in applying.
Centers of
Excellence for Research on Complementary and Alternative Medicine:
Centers of Excellence will support program project grants (P01) to
elucidate the mechanisms of action of CAM modalities. These awards
will provide new opportunities for experienced molecular or cellular
biologists, imaging scientists, immunologists, neurobiologists,
pharmacologists, physiologists, and other scientists to investigate
fundamental questions related to CAM.
Letters of intent
due March 29, 2003; receipt date is April 29, 2003
Developmental
Centers for Research on Complementary and Alternative Medicine:
Developmental Centers will support U19 cooperative agreements in
which CAM and conventional institutions and investigators partner to
conduct exploratory and developmental research projects. These
awards will provide opportunities for CAM institutions and
investigators to strengthen their research expertise and
infrastructure while enabling conventional researchers to gain
clinical and cultural perspectives critical to the conduct of CAM
research. Letters of intent due March 14, 2003; receipt date
is April 15, 2003
Planning Grants for
International Centers for Research on Complementary and Alternative
Medicine: Planning Grants for International Centers will support
exploratory/developmental grants (R21) to enable U.S. and
international institutions to jointly plan exploratory and
developmental studies of traditional/alternative healing approaches.
The Planning Grants will lay the groundwork for developing
applications for an International Center for Research on CAM that
will be called for in 2004. Letters of intent due February 28, 2003;
receipt date is March 28, 2003.
Bioethics and Pharmacogenetics
The Nuffield
Council on Bioethics has issued a consultation paper on ethical
issues raised by the development of personalised medicines, or
pharmacogenetics. The Nuffield Council on Bioethics was
established in 1991 to identify, examine and report on the ethical
questions raised by recent advances in biological and medical
research. The Council seeks to play a role in contributing to
policy-making and stimulating debate in bioethics. In
September 2002, the Council established a Working Party to consider
ethical, social, legal and regulatory issues raised by developments
in pharmacogenetics. The Council intends to publish a report in the
autumn of 2003.
In order to inform
the deliberations of the Working Party, The Neffield Council has
published a consultation document that poses a number of questions
about the implications of pharmacogenetics for the pharmaceutical
industry, providers of healthcare, and individual patients. The
consultation paper may be downloaded from their website:
www.nuffieldbioethics.org/pharmacogenetics. Alternatively,
contact the Council (bioethics@nuffieldfoundation.org) if you would
like to obtain
a printed
copy.The deadline for comments is 19 February 2003.
Funding Opportunities
NCCAM
International Postdoctoral Fellowship,
National Center for Complementary and Alternative
Medicine:
http://grants.nih.gov/grants/guide/pa-files/PA-03-050.html
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