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Washington Highlights: February 4 , 2005

NIH Releases Final Public Access Policy

NIH Releases Final Public Access Policy
NIH Issues New Regulations on NIH Employee Outside Activities
Senate Balks at Appropriations Reorganization
HEA Reauthorization Bill Introduced

Prior Issues

National Institutes of Health (NIH) Director Elias Zerhouni, M.D., Feb. 3 announced the release of the agency's revised policy on public access. The policy, which will become effective on May 2, 2005, is similar to the proposed version published in the Federal Register on Sept. 17, 2004, although the final policy allows authors themselves to specify when their manuscripts should be made publicly available (up to 12 months) after publication. Under the original proposal, all author manuscripts were to be posted six months after publication.

In brief, the policy requests - but does not require - NIH grantees to send to NIH research manuscripts that have been accepted for publication in peer reviewed journals. NIH's National Library of Medicine will compile an archive of these manuscripts and will post them on PubMed Central within the period of time specified by the author.

Many journal publishers, including many non-profit scientific societies, criticized the Public Access policy as likely to damage their ability to finance high-quality, peer-reviewed publications. However, other scientists, patient-advocates, and Congress itself have supported mechanisms to promote such access to the findings from tax-payer-supported medical and health research. Dr. Zerhouni noted that the final policy has attempted to incorporate to the best extent possible these varying concerns. The public access policy is also intended to help NIH better manage its research portfolio.

Information:
Tony Mazzaschi, Interin Chief Scientific Officer, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059

NIH Issues New Regulations on NIH Employee Outside Activities

The National Institutes of Health (NIH) Feb. 1 announced an interim final regulation on the outside activities, financial holdings, and awards of NIH employees. The interim final regulation will go into effect when it is published in the Federal Register in the next week or so, and will remain in effect unless changed by subsequent regulations. Comments will be accepted for 60 days once the Federal Register notice is published.

Under the new regulation, all NIH employees, whether compensated or uncompensated, are prohibited from consulting, advisory or other board service. Compensated teaching, speaking, writing, or editing, is now prohibited with or for the following entities:

Substantially affected organizations (defined to include biotechnology, pharmaceutical, medical device companies, and others with similar interests);

Hospitals, clinics, health maintenance organizations, or other health care providers;

Health insurers;

Health, science, or health research-related trade organizations, professional associations, or consumer or advocacy groups; and

Educational institutions or non-profit independent research institutes that are or recently were NIH funding applicants, grantees, contractors, or CRADA partners.

Also, NIH employees are prohibited from engaging in self-employment activities that involve the sale or promotion of the services or products of the above entities. Gifts and awards to NIH employees are restricted and subject to dollar limits and prior approval.

Under the new regulations, the following activities are allowed, subject to prior approval:

Teaching a course that requires multiple presentations and is part of the established curriculum of a university or college;

Teaching, speaking, or writing performed as part of a continuing professional education program; if funding for the program is from a substantially affected organization such as a pharmaceutical company, it must be funded by an unrestricted educational grant;

Employment with political, religious, social, fraternal, or recreational organizations;

Clinical, medical, or health-related professional practice involving provision of care to individual patients; and

Authorship of articles, chapters or textbooks that are subject to a peer review or substantially equivalent editorial review process; again, if funding is from a substantially affected organization such as a pharmaceutical company, it must be funded by an unrestricted financial contribution.

Under the regulations, NIH employees must terminate prohibited outside activities within 30 days, but can request an additional period of up to 60 days to allow them to responsibly conclude outstanding obligations.

In a Feb. 2 statement, AAMC President Jordan J. Cohen, M.D., stated "[T]he AAMC strongly endorses the new NIH policy regulating the outside activities of its employees. The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists."

Information:
Tony Mazzaschi, Interin Chief Scientific Officer, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059

Senate Balks at Appropriations Reorganization

The chairs of the House and Senate Appropriations Committees are trying to sort out how their panels will be structured for the 109th Congress after Senate Republicans rejected a House proposal to eliminate three of the 13 spending subcommittees. Republicans on the Senate Appropriations Committee dismissed the plan Feb. 2. Committee member Larry Craig (R-Idaho) told reporters. 'We were not brought into this discussion early. There was no effort to negotiate. And as a result, I think the answer's loud and clear: 'No.'"

The plan, put forth by House Appropriations Chair Jerry Lewis (R-Calif.) with the support of the House GOP leaders, including Majority Leader Tom DeLay (R-Texas), would eliminate the VA-HUD Subcommittee, currently the third largest of the annual spending bills. The jurisdiction for VA programs would be combined with defense health accounts and military personnel funds from the Defense Subcommittee and merged with the Military Construction Subcommittee to form a Military Quality of Life and Veterans Subcommittee. Funding for the National Science Foundation and NASA would be moved to the Energy and Water Subcommittee.

Lewis and Senate Appropriations Chair Thad Cochran (R-Miss.) met Feb. 3 to attempt to craft a compromise on the subcommittee structure. If the House and Senate adopt significantly different subcommittee structures, it would seriously complicate efforts to complete the appropriations bills on time. However, it is unclear how far either side will move. House Republicans appear to be moving ahead with the reorganization plan. Lewis has submitted a slate of 10 subcommittee chairs for review by the House Republican Steering Committee. Lewis's proposal eliminates three subcommittee chairs: Ernest Istook (R-Okla.), Transportation and Treasury; Rodney Frelinghuysen (R-N.J.), District of Columbia; and Jack Kingston (R-Ga.) Legislative Branch.

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

HEA Reauthorization Bill Introduced

House Education and the Workforce Committee Chairman John Boehner (R-Ohio) and 21st Century Competitiveness Subcommittee Chairman Howard "Buck" McKeon (R-Calif.) Feb. 2 introduced H.R. 507, the "College Access and Opportunity Act," to reauthorize the Higher Education Act (HEA). This legislation was first introduced in the 108th Congress as H.R. 4283 [see Washington Highlights, May 7, 2004].

Chairman Boehner noted that the legislation is intended to be budget neutral, meaning that any new or expanded benefits would need to be paid for with savings derived from other programs within the bill. As in the previous version, H.R. 507 seeks to reduce origination fees paid by students, and implement variable interest rates on both traditional and consolidation Stafford student loans.