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NiH Drafts Cost Containment Plan -- Page 7 FASEB Thomas S. Edgington, MD PRESIDENT Michael J. Jackson, PhD EXECUTIVE DIRECTOR CORPORATE MEMBERS The American Physiological Society American Society for Biochemistry and Molecular Biology American Society for Pharmacology and Experimental Therapeutics American Association of Pathologists American Institute of Nutrition The American AssoFiation of Immunologists AFFILIATE MEMBER The American Society for Cell Biology PUBLIC AFFAIRS EWSLETTER Gar Kaganowich, Director of Public Affairs VOLUME 23, NUMBER 7 DECEMBER 1990 FASEB Rejects Shift of Research Funding Implementing IOM Report Would Negatively Affect Research A panel of scientists and administrators representing the seven Societic's of FASEB rejected a recent Institute of Medicine (IOM) report that calls for shifting money from research grants into training and facilities. The panel said the implementation of the IOM recommendations would have a "strongly negative impact" on the conduct of research and recruitment of new scientific investigators, and would diminish advances of value to the public. Dr. Thomas S. Edgington, FASEB President and professor of immunology, Research Institute of Scripps Clinic, La Jolla, Calif., made the panel's views known at a news conference held in Washington, D.C. on November 27. Two dozen reporters representing Associated Press, major newspapers and the scientific press attended the session. Dr. Edgington said, "We suggest that the relative allocation of funds between the conduct of research and the indirect support of institutions is not imbal- anced; and that a policy to assure long-term support support of the enterprise as a whole." Dr. Edgington answers reporters' questions following the November 27 press conference. should be based on an increase of The Institute of Medicine report, Funding Health Sciences Research: A Strategy to Restore Balance, was released in September, with formal publication in late November. Its central premise is that the trend of federal support of biomedical research has favored research grants over training and facilities during the last 20 years. The IOM study committee, the FASEB panel's statement said, recommended correcting this perceived imbalance by "switching substantial funds from the primary conduct of research supported by research grants to training and facilities." The Federation panel said it "disagrees" with the premise of the report and "rejects" the IOM recommendations, which would shift funds from research grants to training and facilities. The FASEB scientists said that whereas the federal biomedical enterprise would benefit from expanded support of research grants, training and facilities, "neither research facilities nor training funds will limit (research) productivity in the foreseeable future." "The main factor limiting research productivity," it added, "is the level of support for INSIDE Biomedical Research Caucus.. p 2 NIH, ADAMHA Funding ............ p.5 Nutrition Labeling .................... p.6 NIH Drafts Financial Mgmt. Plan .......................... p.7 Silver Spring Monkeys Litigation Revived Reward Fund .......................... p.11 Edgington Elected to Research!America Board.. p.12 I research grants which pay for laboratory personnel, scientific equipment, re- search supplies and stipends for predoctoral and postdoctoral trainees." The Federation scientists said the IOM recommendations for using research money for other purposes and for increasing recovery of costs for facilities used in federally supported research would result in the loss of about 10 percent of the research grants supported by NIH. Conceivably, the FASEB statement added, as many as 2,000 fully trained, largely young, investigators will not be able to continue their research careers or Continued on Page 3 FEDERATION OF AMERICAN SOCIETIES FOR EXPERIMENTAL BIOLOGY 9650 ROCKVILLE PIKE, BETHESDA MARYLAND 20814 (301) 530-7075

FASEB Newsletter Biomedical Research Caucus Holds First Meeting Prominent Research Scientists Speak The new Congressional Biomedical Research Caucus held its first public forum in October. The Caucus is a "bipartisan coalition of Members of Congress dedicated to increasing congressional awareness and support for basic and clinical biomedical research and to maintain the U.S. competitive edge in this enterprise." The Caucus was organized by Reps. George Gekas (R-Pa.), Roy Rowland ( D-Ga. ), Sonny Callahan (R- Ala.), and Bill Richardson (D-N.Mex.). ASBMB and ASCB were instrumental in convincing the representa- tives to form the group, which now boasts 33 Con- gressional members. Three distinguished biomedical investigators spoke at the first forum on the subject, Why is the U.S. Number One in Biomedical Research? How Do We Maintain Our Status? Dr. Leon Rosenberg, dean of the Yale University School of Medicine, led the panel Dr. Rosenberg: "We simply must reaffirm the national priority for health through research by allocating sufficient funds to meet opportunities, which simply have never been greater." discussion. Other panel members included Dr. Harold Var- mus, professor of microbiology at the University of Califor- nia at San Francisco and winner of the 1989 Nobel Prize for \ledicine, and Dr. Cori Bargmann, a young biomedical re- ~,carcher at MIT. Dr. Rosenberg said that the U.S. has a dominant position in biomedical research because of our national commitment to improve the health of American citizens through re- sea rch, and by providing sufficient financial resources to the endeavor. He also stressed that individual investigators competing with each other for funding though critical ap- praisal by their peers has been a critical element of this success. To maintain our prominence in research, Rosenberg said, "We simply must reaffirm the national priority for health through research by allocating sufficient funds to meet opportunities which simply have never been greater." He added that the biomedical community needs to build a broader base of public support for science and create a strategic agenda for a biomedical research policy that em- phasizes the long-term view. Dr. Varmus detailed his research work and the role NIH funding played in his important discoveries. He said, "41'hat distinguishes our system are the elements that en- December 1990 FASEB and NABT Honor Presidential Biology Teacher Awardees FASEB and the National Association of Biology Teachers (NABT) recently cosponsored a breakfast program to honor the biology teachers who were se- lected for Presidential Awards for Excellence in Sci- ence and Mathematics Teaching. In remarks opening the breakfast, FASEB Execu- tive Director Dr. Michael Jackson congratulated the winners and expressed the Federation's wish "to enhance the quality of science education and the understanding of biology by the next generation of scientists." Awards are presented annually by the President Brlan Slopey of Vermont of the United States to one describes his lesson. middle and high school science teacher in each state, territory and commonwealth. In 1990, 21 of the 54 awards for science teaching went to biology teachers. The winners each submi t an "ideal lesson plan," which is collected, printed and distributed widely to other middle and high school teachers for possible incorpo- ration into their curricula Following remarks by Dr. Jackson, Pat McWethy (executive director of NABT), and Dr. Ken Fisher, (directorof FASEB's Life Sciences Research Office), the winners described the lesson plans they submitted. Dr. Martin Frank, executive director of APS, and Charles Hancock, executive officer of ASBMB, attended the program and described their respective Societies' programs aimed at allowing biology teachers to obtain valuable research laboratory experience during the summer. Two of the winning teachers had previously participated in the ASBMB Summer High School Teacher Research Fellowship Program. J courage first the selection of the best young people to be- come investigators with independent laboratories; Second, the extended and stable funding of those who prove to be productive; and third, the pursuit of novel ideas." Dr. Cori Bargmann discussed what it is like to be trained in the U.S. system and to enter the competitive process to become an independent investigator. Dr. Bargmann said that the promise of discoveries being made by today's established scientists will be fulfilled only if students and voung scientists continue to thrive in the system. She described how difficult the system has become for young investigators because of the current grant funding crisis. Page 2

FASEB Newsletter Excerpts From the FASEB Response to the IOM Report "Funding Health Sciences Research" The real question facing the biomedical research community is: What factors limit our current and future research productivity? Obviously, the whole enterprise would benefit from expanded support of research grants, training and facilities, but given the current level of support for biomedical research, the panel feels that neither research facilities nor training funds will limit productivity in the foresee- able future. The main factor limiting research productivity and long-term vitality is the level of support for research grants, which pay for laboratory personnel, scientific equip- ment, research supplies, stipends for predoctoral and postdoctoral trainees and provide the environment within which training is conducted. The leadership at the National Academy and IOM acknowledge in their foreword that the IOM report "may appear incongruous" in the face of the "crisis in funding of research projects." Congress also recognizes the "critical problem" with "low numbers of new grants" and has taken steps this year to stabilize funding for NIH research project grants. The FASEB panel rejects the report's recommendations which would shift funds from research grants to training and facilities. The report's proposal to shift an estimated $182 million per year by the year 2000 from research grants to training, facilities and centers would reduce the number of research grants by almost 1,000 awards. The report also proposes an increase in the use allowance on facilities by 2.5 fold tharwould further reduce funds available for direct support of research by the equivalent of about 1,200 grants. The report minimized the ultimate impact of these proposals by discussing primarily the first-year costs rather than their com- pounded effects over several years of implementation. Together, these proposals would result in the loss of about 10 percent of the research grants now supported by the NIH and a proportional decrease in the conduct of biomedical research, the goal of this enterprise. Conceivably, as many as 2,000 fully trained (largely young) investigators will not be able to continue their research careers or support their students. Futhermore, students and developing investigators will be much more discouraged from entering careers in biomedical research. The full text of the panel's report appears in the December 1990 issue of The FASEB Journal. December 1990 FASEB Rejects IOM Report (Continued From Page 1) support their students. Further- more, students and developing investigators "will be much more discouraged from entering careers in biomedical research," it added. As far as training is concerned, the statement said the Federation scientists maintain that the inves- tigator-initiated research project grant funded by NIH has assumed "a substantial part of the responsi- bility for providing training op- portunities. Any decrease in re- search project grant support will adversely affect training." Rather than accept the no- growth premise and the shift of funds that "cuts at the heart of the biomedical research system," the FASEB panel statement said, the group "heartily endorses" Con- gress' recent decision to stabilize NIH research support at about 6,000 new and competing grants each year for the next four years. The panel of scientists, repre- senting each of the seven Societies, gathered at the FASEB campus in late October to discuss the IOM report. Edgington Meets With Hill Leaders on Facilities Funding FASEB President Dr. Thomas Edgington, professor in ! the Department of Immunology at the Research Institute of , Scripps Clinic, met with key Capitol Hill leaders concerning facilities funding. The meetings were prompted by the efforts of Senator Terry Sanford (D-N.C.) and other Mem- ~ bers of Congress to get the Bush Administration to develop ' an academic facilities funding strategy for the fiscal 1992 federal budget due to be released in January 1991. i Edgington was joinedby FASEB Public AffairsCommit- tee Chairman Dr. Joseph Grisham and FASEB Office of Public Affairs Director Gar Kaganowich. The delegation met with Senator Sanford, Rep. David Price (D-N.C.), Rep. Bill Lowery (R-Calif.), and staff assistants to Sens. Edward Kennedy (D-Mass.) and Orrin Hatch (R-Utah). During the meetings, Dr. Edgington made a strong case that the funding of primary scientists is at a "disastrous level." He pointed out that many researchers were leaving the biomedical research field despite outstanding scientific I performance. Dr. Edgington told the legislators that all parts of the scientific community - faculty, administrators, etc. - must work together, and there must be long-range planning to assure that scientific research can maintain its momentum. Dr. Edgington said very bluntly, "We cannot have one part of thecommunity damaging another" by moving scarce research dollars to institutions for facilities. He said there is no additional money available to investigators to make up for such losses. Dr. Grisham discussed how reimbursement of the indi- rect costs of research, including amortization of facilities, were taking more and more of the limited research dollars away from investigators. The meetings gave Drs. Edgington and Grisham an opportunity to discuss the funding crisis facing bench scien- tists and to counter the approach designed to put the em- phasis on lesser priorities, such as research facilities. Page 3

FASEB Newsletter December 1990 Final Fiscal 1991 Appropriations Levels For Selected Research Agencies and Programs (in millions) FY 1990 Appropriation FY 1991 Bush Request Final FY 1991 % vs. FY 1990 Alcohol, Drug Abuse and Mental Health Administration .............................................. $2,651.3 $2,836.1 $2,907.1 +9.6% Research Mental Health .................................................................................................... ........ 389.5 413.7 458.7 +17.8 Drug Abuse .................................................................................................... ............ 220.6 258.9 259.4 +17.6 Alcoholism .................................................................................................... ........... 131.6 137.6 140.0 +6.4 Department of Agriculture Cooperative Research Grants .............. ......................................................................... 42.5 100.0 73.0 +71.8 Including: Nutrition, Food Quality and Health .................................................................................. " 5.0 4.0 .. Plant Systems (including plant genome mapping) .......................................................... " 50.0 35.0 " APHIS (Animal Welfare) ...:.............. ...... ................... ............. ......... ....................... ............ 7.5 8.7 9.7 +28.6 Department of Education National Institute on Disability & Rehabilitation Research .............................................. 54.3 54.3 60.3 _ +11.0 Department of Energy Biological and Environmental Research .......................................................... ............. 314.0 338.8 396.4 +26 2 Department of Veterans Affairs Medical and Prosthetic Research .................................................................................. 212.7 198.5 216.8 +2.0 Food and Drug Administration Salaries and Expenses .................................................................................................. 567.1 '497.6 6565 +15 8 National Aeronautics and Space Administration Life Sciences Research ................................................................................................ 106.3 163.0 138.0 +29 8 National Institutes of Health ........... .............................................................................. 7,576.4 7,928.0 8,306.6 +9.6 National Cancer Institute ................................................................. ..........•..•.•.........• 1,634.3 1,694.1 1,723.8 +5.5 National Heart, Lung and Blood Institute ............................................................... - 1,072.3 1,112.5 1,130.7 +5.4 National Institute of Dental Research ............................................................................ 135.7 140.5 149.6 +10.2 National Institute of Diabetes, Digestive, and Kidney Diseases .................................... 581.5 605.3 617.0 +6.1 National Institute of Neurological Disorders and Stroke ................................................ 490.4 512.2 543.4 +10.8 National Institute of Allergy and Infectious Diseases .................................................... 833.0 886.9 910.7 +9.3 National Institute of General Medical Sciences .............................................................. 712.0 745.5 760.5 +6.8 National Institute of Child Health and Human Development ....................... .................. 442.9 461.5 480.9 +8.6 National Eye Institute ........ .......................................... ................................................ 236.5 2474 253.9 +6.9 National Institute of Environmental Health Sciences .............. .._..............................- 229.2 235.8 243.1 +6.1 National Institute on Aging .............................................................................................. 239.5 248.9 324.7 +35.6 National Inst of Arthritis & Musculoskeletal and Skin Diseases .................................... 168.9 176.1 193.7 +14.7 National Institute on Deafness & Other Communication Disorders .............................. 117.6 122.8 135.2 +15.0 National Center for Research Resources ..... ........................................... ...................... 337.1 319.2 335.5 -0.5 National Center for Nursing Research ............................................................................ 33.5 35.1 39.8 +18.8 National Center for Human Genome Research .............................................................. 59.5 108.0 87.6 +47.2 John E. Fogarty International Center .....- ..................................................................... 15.7 16.4 17.6 +12.1 National Library of Medicine ......... ..._ .................. ......... .............................. ........... _.... 85.7 89.9 92.1 +7.5 Office of the Director .... ............. ............. .... ................................................................. 89.9 83.0 98.2 +9.2 Buildings and Facilities ...................... ............................................................................ 61.0 86.9 168.7 +176.6 National Science Foundation ....................................................................................... 2,083.6 2,383.0 2,356.0 +13.1 Research ........ ..... ._......... _...... ............. .. ............................................. ................. 1,6060 1,851.5 1,694.2 +5.5 Antarctic Program .................................................................................................... ...... 151.7 175.0 175.0 +15.4 Education and Human Resources ..........................................................................•..... 204.3 251.0 322.4 +57.8 Facilities .................................................................................................... ........................ 19.7 20.0 20.5 +4.1 .............. Program Development and Management ............................................... . " " 101.0 " Office of Science and Technology Policy ............................................................................. 2.8 3.3 3.6 +28.6 ' Does not include the Administration's proposal to fund $157.2 million in additional salaries and expenses through user fees, which Congress rejected. " New appropriation line item. Page 4

FASEB Newsletter December 1990 Fiscal 1991 NIH Spending Up 9.6 Percent; ADAMHA Research Up 15.7 Percent NIH Expects to Fund 5,785 New Grants; Up 1,200 Over 1990 Level Despite the general budget chaos, when the deals were done and the appropriations bills signed into law, biomedi- cal research fared well. The National Institutes of Health received a fiscal year 1991 appropriation of $8,306,648,000, which is $731 million or 9.6 percent more than the appro- priation for fiscal 1990. The final fiscal 1991 appropriation of $2,907,109,000 for the Alcohol, Drug Abuse and Mental Health Administration is $256 million or 9.7 percent more than fiscal 1990. For ADAMHA research activities, Con- gress approved $858 million, a 15.7 percent boost over the fiscal 1990 level. According to figures recently released by NIH's Finan- cial Management Division, NIH anticipates funding 5,785 new and competing research project grants in fiscal 1991, up 1,208 from the estimated 4,577 funded in fiscal 1990. NIH projects that a total of 21,186 grants will be funded in fiscal 1991 -- 926 more than the 20,260 estimated to be funded in fiscal 1990.' NIH projects that the average new grant in fiscal 1991 will cost $203,996. For training, NIH estimates the final appropriations bill will fund 12,141 training positions, up 346 from fiscal 1990. A stipend increase for both post- and pre-doctoral trainees is expected to be announced shortly. When President Bush proposes the fiscal 1992 budget to Congress, he is expected to propose a formal cost-of-living escalation for training stipends and a cap on tuition reimbursement levels. ADMAHA expects to fund 746 new and competing grants in fiscal 1991, down from the 872 estimated to be funded in fiscal 1990. However, ADAMHA expects to support a total of 2,545 grants, up 203 from the 2,342 funded in fiscal 1990. The numbers are skewed because ADAMHA port added, "The conferees believe that the amounts agreed to are sufficient to fund grants approved by the Institutes with no arbitrary downward negotiation of awards." Edgington wrote Raub, "The Congress wisely recog- nized that the NIH extramural research grant is the founda- tion of America's biomedical research enterprise. The Fed- eration believes that the full funding of 6,000 new and competing grants in fiscal 1991 is essential to restore the severe cuts in awards made in the past several years." National Science Foundation Budget Up 13 Percent The final fiscal 1991 appropriation for the National Sci- ence Foundation (NSF) provides a 13 percent increase for NSF. However, the agency lost $40 million at the last mo- ment because the Office of Management and Budget would not permit the agency to finance part of the Antarctic pro- gram from Defense Department funds. As a result, the final tally of $2.316 billion for NSF ended up below the House and Senate approved levels. Within the NSF, the largest budget increase went for education and human resource activities, up 57.8 percent to $322.4 million. Research was boosted 5.5 percent to almost $1.7 billion. The final fiscal 1991 appropriations levels for selected research agencies and programs is consolidated in the chart on page 4. New Budget Rules As part of the final fiscal 1991 budget package, new rules were approved in an effort to control the growth in federal spending. The rules provide for separate spending caps for will fund 329 more continuations than it did last year. Research training at ADAMHA will increase by 207 positions in fiscal 1991, to a total of 1,660 research training slots. Edgington Urges NIH to Fund 6,000 New Grants In a November 1 letter to NIH Acting Director William Raub, FASEB President Thomas Edgington urged NIH, "to comply with the directives of the two Appropria- tions Committees and the Labor-HHS- Education conferees in regard to support- ing6,000 new and competing NIH research project grants in the current fiscal year." The reports of both the House and Senate Appropriations Committees on the recently enacted Labor-Health and Human Service- Ed ucation Appropriations bill directed the funding of 6,000 new and competing re- search project grants by the National Insti- tutes of Health in fiscal 1991. The joint House-Senate Conference Committee re- Continued on Page 6 Page 5

FASEB Newsletter December 1990 Nutritional Labeling Legislation Passes Will Preempt Most State Labeling Efforts A compromise nutrition labeling bill is now law. The bill, H.R. 3562, sponsored by Rep. Henry Waxman (D- Calif.), combines elements of a number of nutrition labeling bills that had been introduced in the House. The final legislation closely tracks proposed regulations on nutri- tional labeling issued by the Bush Administration earlier this year. The enacted bill requires nutrition labeling for most pro- cessed foods subject to Food and Drug Administration regulations. Foods subject to U.S. Department of Agricul- ture regulations are not covered. The legislation requires retailers to post or otherwise provide nutrition information for the 20 most commonly consumed types of raw agricultural products, fish and seafood. Nutrition information must disclose the amount of "total fat, saturated fat, cholesterol, sodium, total carbo- hydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size or other unit of measure." TheSecretaryof Health and HumanServiceswill be required to issue definitions for terms such as "free," "low," "light" or "lite," "reduced," "less," and "high" when used tci describe the nutrient content of foods. Dr. Richard Allison, executive officer of AIN, said, "This legislation is not inconsistent with AIN's position on nutritional labeling, but we had hoped that label require- ments would be extended to food products subject to U.S. Department of Agriculture regulations as well." (Continued From Page 5) Fiscal 1991 Appropriations domestic discretionary, international, and defense pro- grams. If the caps are breached, funding cuts are imposed until the cap is met. The caps are in place for fiscal years 1991-1993. Savings under one cap cannot be shifted to another. However, the new law provides for nine spending ad- justments, including changes for inflation and $1.5 bil- lion special add-ons for both fiscal 1992 and 1993. Funding for biomedical research programs fall under the domestic discretionary cap. The Administration and congressional negotiators thought they allowed a sizable amount for increases in fiscal 1992 and 1993. However, The New York Times reported on December 5 that OMB Director Richard Darman now believes that no cushion exsists because of appropriation increases enacted at the end of the congressional session. Dar- man and the Administration have yet to publicly com- ment on their projections. The new rules are complex and it will take some practical experience to fully understand their effect. The bill also sets up guidelines for health claims on food labels. It prohibits claims about the benefits of one nutrient that are misleading due to the levels of other nutrients in the food. It also requires that disclosures about the level of certain nutrients be placed proximally and be given equal prominence with the disclosures of the levels of related nutrients. For example, cho- lesterol content must be placed beside and given equal prominence with saturated fat content. This requirement also applies to information about dietary fiber and fat con tent. The final measure re- quires the Secretary of HHS to determine whether there is sufficient agreement among Rep. Henry Waxman (D-CaliL) scientific experts to support particular disease-related health claims about nutrients. The House version of the bill asked the Secretary to rule only on the relationship between cal- cium and osteoporosis, dietary fiber and cancer, lipids and cardiovascular disease, lipids and cancer, sodium and hyper- tension, and dietary fiber and cardiovascular disease. The amended final bill also asks for a determination of the validity of the link between folic acid and neural tube defects, antioxidant vitamins and cancer, zinc and immune function in the elderly, and omega-3 fatty acids and heart disease. The final bill includes a food industry-backed provision to preempt most state nutrition labeling laws, so manufac- turers will not need to tailor labels to the various require- ments of individual states. The exception is for health warnings concerning potential toxins or possible allergic reactions, which states may continue to require to be printed on food labels. Regulations issued earlier this year by HHS were silent on the state-preemption issue. Misconduct Procedures Released The Public Health Service has made available its revised internal guidelines for dealing with miscon- duct in science. The document, "Policies and Proce- dures for Dealing with Possible Misconduct in Extra- mural Research," can be ordered by calling the NIH Office of Scientific Integrity (301-496-2624). FASEB and other organizations have been review- ing the procedures and will make informal recommen- dations for modification to the Public Health Service. The document was made public following its introduc- tion into evidence during court proceedi ngs brought by University of Wisconsin neurologist Dr. James Abbs challenging the NIH Office of Scientific Integrity's in- vestigatory process. A decision in that case is pending. Page 6

FASEB Newsletter December 1990 NIH Cost Containment Draft Generally Accepts Congress's Directives Increased Funding of Grants "Out of Order" NIH has issued a draft financial management plan that accepts the broad outlines of recent appropriation commit- tees' directives to better manage grant costs. FASEB will testify on the draft plan at a December 17 meeting of the Director's Advisory Committee. FASEB Societies have named member research scientists to a panel to develop a consensus response. In the reports accompanying the fiscal 1991 Labor-HHS- Education spending bill, the appropriations committees stated their view that the precipitous decline in the number of new and competing grants was due to the increasing length and cost of grants and outlined a specific plan to reverse the decline. The committees ordered NIH to re- spond to their plan by mid-January. The committees di- rected NIH to exercise control over the average cost and length of grants so that it can continue to fund a stable pool of 6,000 new grants annually and a total of 24,000 grants within four years. NIH's d raf t financial managenient plan rejects or avoids commitments to some of the specifics because of NIH con- cerns that the appropriations levels needed to support the range of activities it has been called upon to maintain may not be forthcoming. The NIH plan specifically avoids committing the agency to funding 6,000 new and compet- ing grants stating: "It is also important to recognize that the goal of achieving a specified target number of grant awards should not overshadow NIH's need to maintain a research portfolio that reflects a judicious balance among its various funding mechanisms." The plan outlines how NIH plans to deal with research project grants, research traini ng, center grants, other mecha- nisms, and the NIH Director's discretionary fund. NIH said it used three principles as the basis for developing its plan: flexibility to respond to health emergencies and scientific opportunities; balanced research portfolios within institutes and centers; and cost management through peer review actions and administrative controls. Length of Awards NIH proposes that the committees' directive to reduce the average length of grants from 4.3 years to 4.0 years be achieved by "awarding an appropriate mix of three-year and five-year grants, by emphasiz- ing four-year grants, or by a combination of both approaches. NIH notes that reducing the average award length to four years may increase costs be- cause additional resources will be needed to review and evaluate more frequent applications. Also, competing continuation grant applications have "traditionally shown significant budgetary increases over the previous non-competing grant." NIH rejects as "inappropriate" the committees' instruction that indirect costs be considered at the study section level. Instead, NIH suggests that "Institute and Center staff, with advice from their Councils/Boards, shall assume the major burden of cost control" by adjusting budgets at the time awards are made. "This can be partially accomplished by a more precise cost analysis of the IRG-(Initial Review Group, or study section) recommended budget figures." "Out of Order" Funding To achieve congressionally mandated limits on average grant costs, NIH will continue the trend toward funding some research projects "out of order" of their priority scores, not only because of anticipated benefits, but also because of total costs. However, NIH cautions that "it iscritical that the quality of research not be sacrificed in the interest of award- ing low-cost grants." NIH also proposes that out-year grant commitments be "indexed to the first year's adjusted award level plus an appropriate amount for programmatic escalation (currently 4 percent)." The amounts to be awarded in future years would be provided on the Notice of Grant Award, and "no further reductions would be made." NIH seeks to protect itself from being boxed in by commitments it lacks funding to meet. In the draft financial management plan, NIH notes that Congress must appropri- ate "sufficient funds to support the commitment base." The plan refers to the committee report language stipulating that public health emergencies and special initiatives (e.g., AIDS and the genome project) must be considered as additions to the NIH funding base. NIH raises the possibility of fixing the indirect cost rate negotiated for the initial year of a grant as the rate for that institution throughout the term of the grant. NIH predicts that cost containment measures will force grantees to seek co-funding from other government agencies, private foun- dations, and industry, which may require revisions in NIH Continued on Page 8 ~ NIH Competing Grants ao 38 ...... :............. :............. ;............. ;.......... ' ........... :............. ;............. ;...... 36 . . . . . . . . . . . . . 34 . . . . , . . , . 32 ~ , , . , . . . ~ : • .... .......... .............. :........... ...... 30 ...... ------------- :.............. }------------- ;------------- ~............. ~----- .... ~..-----------~------ o- 28 .. ......... ......... ......... ........• ......... ....... .... .. 26 .. ......... ......... _ .......- - ......... ......... ---..... .. 24 , . . . , . . ;.. 22 ......i ............. i............. i............ -i.............. ;............. i............ i............. i...... p 1989 1984 1985 1986 1987 1968 1989 1996 est. Fiscal Year -+- Award Rate -~- Success Rate Page 7

FASEB Newsletter December 1990 Research Largely Unaffected by Mid-Term Election Results Congressman George Brown (D-Calif.) New Chairman of Science Panel Mid-term congressional elections will have little direct effect on federal support of biomedical research. The Demo- crats gained one seat in the Senate, giving them a 56-44 majority when the Congress reconvenes in January. The Democrats gained nine seats in the House. The Democratic majoritv in the House will be 267-167-1. The "1" represents Vermont Socialist Bernie Sanders who beat incumbent Peter Smith. The increased Democratic margins will make it more difficult for President Bush to sustain his vetoes, especially on the House. Senate: Senator Tom Harkin (D-lowa), chairman of the Labor-HHS-Education Appropriations Subcommittee, hand- ily won reelection. Other members of the Subcommittee up for reelection, Senators Ted Stevens (R-Alaska) and Mark Hatfield (R-Oreg.),also won reelection. The only member of the Subcommittee (and full committee) not returning is Senator James McClure (R-Idaho), who is retiring. Member- ship on the Senate Labor and Human Resources Committee, which handles NIH and ADAMHA reauthorizations, should be unchanged. No members retired, and the seven mem- bers of the Committee up for reelection won easily. Cong. Robert Smith (R-N.H.) was elected to fill the Senate seat being vacated by Senator Gordon Humphrey (R-N.H.). Smith is an active supporter of the anti-vivisectionists. House: Rep. William Natcher (D-Ky.), chairman, and all other members of the House Labor-HHS-Education Ap- propriations Subcommittee won reelection. Cong. Doug (Continued From Page 7) NIH Financial Management Plan administrative procedures regarding co-funding. Success Rate . NIH proposes to abolish the practice of "approv- in," grant applications, which has led to creation of a :ategorv of grants that are approved but not funded. In.tcad, NIH proposes to follow the procedure used by c,ther government agencies, namely, dividing the num- ber of grants awarded by the number of applications revie~ved to pr(xiuce a "success rate." Center Grants NIH rejects the committees' directive to limit the number of research centVrs supported because the agency wants flexibil ity in how it addresses problems, although it acknowledges the need to exercise cost control. NIH points out that some of the increased number of centers ~.•ere established because of congressional directives. Copies of FASEB's December 17 testimony to the Advisory Committee to the NIH Director will be avail- able after that date by calling 301-530-7075. Walgren (D-Pa.), former chairman of the House Science, Re- search and Technology Subcommittee, was defeated by Rick Santorum. Walgren had been active on science educa- tion issues and was on the House Health and the Environ- ment Subcommittee. Congressman Jim Bates (D-Calif.), also a member of the sub- committee, was defeated. Sixteen-term Con- gressman Robert Kasten- meier (D-Wis.) lost to former newscaster Scott Klug. Kastenmeier, the second-ranking member of the House Judiciary Committee, was chairman of the subcommittee with authority over patent is- sues and had been active on several biotechnology- related issues, including animal patenting. The House Democratic Caucus on December 6 voted to oust Cong. Glenn Anderson (D-Calif.) as chairman of the House Public Works Committee. The caucus subsequently selected Cong. Robert Roe (D-N.J.) as chairman of the publ ic works panel. Roe had served as chairman of the House Science, Space and Technology Committee for the past four years and was active on scientific misconduct issues. He also recently has been involved in efforts to negotiate the transfer of the so-called Silver Spring monkeys from the Delta Primate Center to the San Diego Zoo. The caucus selected Cong. George Brown (D-Calif.) to be the new chair of the science panel. Referenda: Voters in San Diego County, California overwhelmingly approved an advisory referendum author- izing the county to sell unwanted and unclaimed pound animals to the University of California at San Diego School of Medicine. New Peer Review Consultant File NIH and ADAMHA have established a new con- sultant file of peer reviewers. The computerized data base will serve as a source from which candidates for membership on NIH and ADAMHA committees and for other peer review activities will be drawn. The data base is being compiled solely from re- sponses to an NIH/ADAIvg-lA Consultant File Infor- mation Form. Every Public Health Service grantee was sent an information form. Other scientists can receive the form by writing to NIH/ ADAMHA Consultant File, 4733 Bethesda Avenue, Suite 725, Dept. 02, Bethesda, MD 20814. More information is available in The NIH Guide to Grants and Contracts, October 5, 1990, page 1. Page 8

FASEB Newsletfier Legislative Roundup Beforeadjourning for the year, the 101st Congress completed action on a number of relevant bills: MEDICAL DEVICES: Congress passed H.R. 3095 over- hauling the federal regulation of medical devices. The measure streamlines the marketing approval process for new devices, improves the monitoring of devices already on the market, and makes it easier to recall dangerous ones. Under the new legislation, deaths and injuries caused by medical devices must now be reported directly to the FDA, not to the manufacturer. Research institutions using human subjects urill besubject to these new reporting requirements. FDA has been charged with developing procedures for tracking fatality and injury reports to allow faster recalls. An over- haul of medical devices regulatory legislation in 1976 inad- vertently created a large loophole, which allowed many new devices to find their way to market without going through the normal approval process. FDA REVITALIZATION: Congress approved legisla- tion (S. 845) to "revitalize" the Food and Drug Administra- tion. The bill authorizes $100 million for consolidating FDA's many Washington offices into a new administrative and laboratory complex. According to Senator Orrin Hatch (R-Utah), the principal backer of the bill, the FDA is cur- rently housed in 23 different buildings at seven sites in Washington, .D.C. Congress approved $8.35 million for FDA buildings and facilities in fiscal 1991 appropriations action. The bill also allows the FDA Commissioner to ap- point technical and scientific review groups, a power for- merl,v held by the Secretary of Health and Human Services. PRESCRIPTlON DRUG DlSCOUNTS: The final budget reconciliation bill (H.R. 5835) contained provisions aimed at sa ving $1.9 billion over the next five yearsby requiring phar- maceutical companies to grant deep discounts for pur- chases by the Medicaid program. Provisions contained in earlier legislative vehicles mandating "therapeutic substitu- tion" were dropped. ASPET President Dr. Thomas F. Burks had written to key members of the House and Senate opposing unau thorized therapeutic substitution of prescrip- tion drugs. ORPHAN DRUG ACT AMENDMENTS: President Bush on November 9 vetoed legislation to revise and extend the Orphan Drug Act. The legislation (H.R. 4638) would have extended incentives for drug companies to develop prod- ucts to treat diseases that affect fewer than 200,000 Ameri- cans. The amendments would have permitted two or more companies to share exclusive marketing rights for orphan drug products developed after enactment. The bill, intro- duced by Cong. Henry Waxman (D-Calif.), represented a compromise among industry, public-interest groups, and the National Organization for Rare Diseases. Bush's veto came as a surprise, since it was not threatened during Congressional consideration of the measure. Bush said he feared the bill would decrease the willingness of firms to develop orphan drugs. December 7990 NIH Reauthorizations Fail to Pass Foundation and Rehabilitation Research Center Provisions Survive Before adjourning, Congress failed to reauthorize sev- eral NIH programs, including programs at the cancer and heart institutes. Legislation attached to the reauthoriza- tion bills also died, includ- ing measureson misconduct in science, women's health research, fetal tissue trans- plantation, and contraception and fertility research. However, Congress did give final approval to two proposals: the creation of a National Center for Medical Rehabilitation Research within the National Institute for Child Health and Hu- man Development and to a private foundation to bring 111111111111 11111111111111 outstanding senior and mid-level visiting scientists to NIH at higher salary levels than the government may pay. Controversy over contraceptive and fertility research and fetal tissue transplantation issues helped kill the more far-reaching House and Senate committee-passed bills. Provisions relating to misconduct in science also failed to pass. A House version of the NIH reauthorization bill contained a definition of scientific misconduct that did not acknowledge the role of honest error in the scientific proc- ess. FASEB and its Societies were able to persuade Rep. Henry Waxman (D-Calif.) to sponsor an amendment in committee to address FASEB's concerns. The amendment was adopted by voice vote. APS Develops Animal Facilities Bill A model bill for the care and treatment of animals held by pounds, shelters, pet stores, kennels, and animal clinics and hospitals has been developed by the American Physiological Society. The Model Animal Facilities Bill is designed to be of- fered as an alternative to state or local legislative propos- als seeking to restrict or regulate animal useby research or educational institutions. In most locations, there are no standards concerning the care and treatment of animals held by pounds, shelters, pet stores or other facilities other than at research or educational institutions. The APS facilities legislation is the second model bill developed by the Society's Committee on Animal Care and Experimentation. Last January the committee began distributing a Model Pound Release Bill. Copies of both model bills are available to members of the FASEB Societies by writing to APS, 9650 Rockville Pike, Bethesda, MD 20814. Page 9

FASEB Newsletter Animal Research Briefs Vandals Disrupt Research at Buffalo Medical Center A reward of $1,000 is being offered for information leading to the arrest and conviction of burglars who dis- rupted two long-term research projects at an animal facility at the State University of New York at Buffalo Medical Center. Approximately 750 lab animals were released from cages in five rooms of the animal facility on October 27. Twelve research projects were affected by the release of 89 rats, 620 mice, 35 hamsters, 1 quail and 5 chickens. Animals from ten experiments were recovered and researchers will be able to resume those projects. The two experiments most seriouslyaffected involve studiesin trans- plantation immunology and the search for a vaccine for schistosomiasis. The two experiments total $2.3 million and are funded by NIH, the Officeof Naval Research and others. Following the burglary, an anonymous telephone caller said the break-in was conducted by a group calling itself "Animal Now." Police are still looking into that claim. Three Arrested in 1986 University of Oregon Break-In Three individuals have been arrested and charged with burglary, conspiracy to commit burglary, theft and criminal mischief for their alleged involvement in a 1986 break-in at the University of Oregon. During the break-in, more than 150 animals were stolen and property damage was esti- mated at in excess of $58,000. Indictments in the case grow cni t of an investigation by a Sacramento, Calif. grand jury. In January 1988, Roger Troen was convicted of first-degree theft, second-degree burglary and conspiracy to commit second-degree burglary in the incident. APHIS Reports to Congress The U.S. Departmentof Agriculture's Animal and Plant Health Inspection Service (APHIS) reports that 1,754,456 animalsother than ratsand mice wereuscd in experimenta- tion in fiscal year 1989, up 6.8 percent over fiscal year 1988. The figures come from the annual report of the Secretary of Agriculture to Congress under the requirements of the Animal Welfare Act. According to the report, 156,443 dogs, 50,812 cats, 481,712 guinea pigs, 389,042 hamsters and 471,037 rabbits were used in experimentation in 1989. The numberof primates used in fiscal 1989 was 51,688 -- up just 47 over fiscal 1988. APHIS also reports a large increase in the number of Freedom of Information requests it has received over the past three years. APHIS received 384 requests in 1987, 498 in 1988 and 630 in 1989. However, APHIS also reports a significant drop in the number of violations submitted as a result of its investigation activities. APHIS recorded 122 violations in 1989, down 237 percent from the 4l 1 violations submitted in 1988. December 1990 Wait for New NIH Director Continues Former NIH Director James Wyngaarden announced his resignation on April 20,1989, more than 19 months ago. There still is no new permanent NIH director. The New York Times, Wash- ington Post, and Associated Press reported on September 10 that Bernadine Healy,MD, a card i- ologist who is research director at the Cleveland Clinic, had been tapped as the new director. But after more than two months, the White House has sent no nomination to the Senate. White House Personnel s'W l/ Director Chase Untermyer has Bernadine Healy, MD no comment on the situation. Dr. Bernadine Healy's office also has no comment. In other personnel news, David A. Kessler,MD,JD,has been confirmed as the new commissioner of the Food and Drug Administration. Kessler, 39, was medical director of the hospital of Albert Einstein College of Medicine and also taught food and drug law at Columbia University's law school. Kessler served as a consultant to Senator Orrin Hatch (R-Utah) in the early 1980s when Hatch was chairman of the Senate Labor and Human Resources Committee. Silver Spring Monkeys Litigation Revived By Supreme Court The Supreme Court announced on November 26 that it would review a procedural issue that has grown out of litigation concerning the so-called Silver Spring monkeys. In 1988, a numberof anti-vivisectionistgroups sued in Louisiana state courts in an effort to block the planned euthanization of some of the monkeys, who had been transferred to the Delta Primate Center at Tulane University. NIH successfully asked that the case be moved to a federal court. The NIH motion was based on a federal statute that allows suits against federal officials to be transferred to federal courts. The anti-vivisectionists contend that the case should not have been transferred. They argue that the statute applies only to federal officers, not to federal agencies. The Supreme Court agreed to rule on the question. The anti-vivisectionists have had no success in achiev- ing standing in federal courts. However, state court standing requirements vary widely. The anti-vivisec- tionists believe they may be able to gain standing in many states if they are able to keep suits from being transferred to the federal level. Attorneys have 75 days to submit their written briefs to the court, which will then decide whether to schedule oral arguments. Page 70