# ScienceScope

Science  28 Nov 2003:
Vol. 302, Issue 5650, pp. 1487
1. # Pediatric Rule Restored

Lawmakers restored rules requiring drug companies to include children in clinical trials of compounds likely to be given to youngsters. The Food and Drug Administration (FDA) imposed the so-called pediatric rule mandating the studies in 1998. But last fall, after a challenge from free-market advocacy groups, a federal judge struck it down, ruling that Congress hadn't given the agency authority to enforce it (Science, 25 October 2002, p. 723). Health advocates applaud the rule's return but fret about a “sunset” clause that will cause it to expire in 2007. Says Marjorie Tharp of the American Academy of Pediatrics in Washington, D.C.: “We are not happy about having to open this up again.”

2. # DOE Gets Slight Increase

A $27 billion annual spending bill will give the Department of Energy's science programs a 5.8% boost to$3.5 billion. Earmarks absorb much of the increase, however, leaving many research budgets flat. Exceptions include fusion research, which will grow 7% to $264 million, and computing studies, which will get a 22% boost to$204 million. The 2004 appropriations measure also backs a controversial plan to study new nuclear weapons (Science, 4 July, p. 32). However, the $13.5 million initiative includes only half of the$15 million requested for earth-penetrating weapons.

The 21st Century Nanotech Research and Development Act (S. 189) authorizes the government to spend $3.7 billion over the next 4 years on the science of the very small. Universities will compete for one new center on nanoscale manufacturing and another on “nanotechnology preparedness,” which will study the social, ethical, and training issues raised by the field (Science, 4 July, p. 27). The bill also asks the National Academy of Sciences to study responsible development of nanotechnology, including its possible use for “enhancement of human intelligence.” 4. # TESLA Gets Russian Help Russia is throwing an unusual lifeline to one of the highest profile science efforts in the Balkans. Next month, the Russian government is expected to sign a deal that would give Serbia more than$7 million worth of new equipment for the TESLA accelerator facility under construction near Belgrade. The bounty—including a particle injection system—is part of a broader agreement between the two countries to clear more than \$300 million in Cold War-era debt.

TESLA, one of the few remaining jewels of Serbia's withered scientific community, will be used for fundamental physics research and for making medical isotopes (Science, 30 August 2002, p. 1456). TESLA's cyclotron is expected to be commissioned in September 2005, along with a beamline for producing the radioisotope fluorine-18 for use in positron emission scanning. And if promised assistance from Belgium, France, and Italy materializes, TESLA could be producing other isotopes by 2006. “We are fighting to make the project stable,” says Nebojsa Neskovic, director of the TESLA Centre.

5. # Caution Urged on White House Peer Review Policy

White House regulatory czar John Graham faced pointed criticism last week at a National Academy of Sciences workshop on proposed guidance for peer review of scientific documents used in setting U.S. government regulations.

The draft bulletin from the Office of Management and Budget's (OMB's) Office of Information and Regulatory Affairs lays out many requirements for all federal agencies, from making reviewers' comments public to screening out experts with either agency or industry ties that could be conflicts of interest (Science, 5 September, p. 1307). Although some panelists at the workshop supported the plan, others warned against a one-size-fits-all approach.

“Be careful in imposing blanket new procedures that imply that there's a fundamental management problem,” said Michael Taylor of the Washington, D.C., think tank Resources for the Future, noting that ensuring scientific quality is “at the heart of what [the Food and Drug Administration] does.” Others predicted that the new rules could lead agencies to rely on paid reviewers, potentially lowering quality. And George Washington University epidemiologist David Michaels argued that OMB had provided “not a single example” of why the new procedures are needed. The public can comment on the guidance until 15 December, and agencies have a month longer.