Congressional Affairs (Prepared January 23, 2007)

Appropriations

On December 9, 2006, the President signed into law P.L. 109-383, the third Continuing Resolution for FY 2007, to provide funding for agencies including NIH without enacted appropriations. This CR will extend funding through midnight on February 15, 2007, and for NIH under the same terms and conditions as were in effect in FY 2006.

FY 2008 Outlook: House Appropriations Committee Chairman David Obey and Senate Appropriations Committee Chairman Robert Byrd announced in December that they intend to pass a "joint resolution" to fund government operations for the remainder of FY 2007. The exact terms of this resolution continue to be negotiated.

Bills Passed at the End of the 109th Congress

H.R. 864 - On December 9, 2006, both chambers of Congress passed H.R. 864, the STOP Underage Drinking Act. The President signed the bill into law on December 20, 2006, as Public Law 109-422. The law authorizes grants to reduce the rate of underage alcohol use and binge drinking among students at institutions of higher education, data collection to identify the scope of the problem and research into the effects of alcohol on developing brains. The NIDA Director would serve, with other agency heads, on an interagency coordinating and planning committee.

H.R. 6164 - On December 8, 2006, the House and Senate passed H.R. 6164, the National Institutes of Health Reform Act, as amended. Provisions would revise Title IV of the PHS Act and create the Division of Program Coordination, Planning, and Strategic Initiatives, to be supported by the Common Fund. The bill authorizes appropriations for NIH of $30,331,309,000 for FY 2007, $32,831,309,000 for FY 2008 and such sums as necessary for FY 2009. The bill calls for the establishment of a Scientific Management Review Board to review the structure of NIH every seven years. The bill also authorizes the NIH Director to award grants for demonstration projects for research bridging the biological sciences with the physical, chemical, mathematical, and computational sciences; and authorizes the establishment of demonstration programs that award grants, contracts, or engage in other transactions, for high-impact, cutting-edge research demonstration programs. The legislation was signed by the President on January 15, 2007, and is cited as Public Law 109-482, the National Institutes of Health Reform Act of 2006. (A complete summary of this bill, provided by the NIH Office of Legislative Policy Analysis, is included at the end of the Congressional Affairs section).

S. 3880 - On November 27, 2006, the President signed into law S. 3880, the Animal Enterprise Terrorism Act (P.L. 100-374). Senators James Inhofe (R-OK) and Dianne Feinstein (D-CA) introduced the bill to expand criminal prohibitions against the use of force, violence, and threats involving animal enterprises and increases penalties for violations of these prohibitions. Building upon the Animal Protection Act of 1992, the Animal Enterprise Terrorism Act will stiffen original penalties for crimes against commercial or academic enterprises that use or sell animals or animal products for profit, food or fiber production, agriculture, education, research, or testing. Further, the hallmark of the new law is protection for tertiary targets of such crimes. Specifically, the law extends protection to the immediate families, spouses or intimate partners, and those doing business with persons involved in an animal enterprise.

110th Congress

As a result of the November 2006 elections, both the Senate and House of Representatives are now under Democratic Party control. As a result of this shift, there are significant changes to both the leadership and membership of those committees most relevant to NIDA's work. Also, certain committee jurisdictions have changed.

Senate: In the Senate, primary focus is on the

• Committee on Appropriations (Subcommittee on Labor, Health and Human Services, and Education; Financial Services [now with ONDCP jurisdiction] and Commerce, Justice, Science;
• Committee on Health, Education, Labor, and Pensions (HELP) (subcommittees yet to be determined);
• Committee on the Judiciary; and the
• Caucus on International Narcotics Control (this is an officially recognized Caucus, established by law in 1985).

House: In the House, primary focus is on the

• Committee on Appropriations (Subcommittee on Labor, Health and Human Services, Education, and Related Agencies; Financial Services [now with ONDCP jurisdiction], and Commerce, Justice, Science and Related Agencies);
• Committee on Energy and Commerce (Subcommittee on Health); and the
• Committee on Oversight and Government Reform (formerly Government Reform). (Subcommittee on Domestic Policy - formerly Criminal Justice, Drug Policy, and Human Resources).

Subcommittee Rosters - Senate

Appropriations - Labor, Health and Human Services, and Education

Democrats Tom Harkin, IA (Chair) Daniel Inouye, HI Herbert Kohl, WI Patty Murray, WA Mary Landrieu, LA Richard Durbin, IL Jack Reed, RI Frank Lautenberg, NJ

Republicans Arlen Specter, PA (Ranking Member) Thad Cochran, MS Judd Gregg, NH Larry Craig, ID Kay Bailey Hutchison, TX Ted Stevens, AK Richard Shelby, AL

Appropriations - Financial Services

Democrats Richard Durbin, IL (Chair) Patty Murray, WA Mary Landrieu, LA Frank Lautenberg, NJ Ben Nelson, NE

Republicans Sam Brownback, KS (Ranking Member) Christopher Bond, MO Richard Shelby, AL Wayne Allard, CO

Appropriations - Commerce, Justice, Science

Democrats Barbara Mikulski, MD (Chair) Daniel Inouye, HI Patrick Leahy, VT Herbert Kohl, WI Tom Harkin, IA Byron Dorgan, ND Dianne Feinstein, CA Jack Reed, RI Frank Lautenberg, NJ

Republicans Richard Shelby, AL (Ranking Member) Judd Gregg, NH Ted Stevens, AK Pete Domenici, NM Mitch McConnell, KY Kay Bailey Hutchison, TX Sam Brownback, KS Lamar Alexander, TN

Health, Education, Labor, and Pensions (as of this writing, subcommittees pending)

Democrats Edward Kennedy, MA (Chair) Christopher Dodd, CT Tom Harkin, IA Barbara A. Mikulski, MD Jeff Bingaman, NM Patty Murray, WA Jack Reed, RI Hillary Rodham Clinton, NY Barack Obama, IL Bernard Sanders, (I), VT Sherrod Brown, OH

Republicans Mike Enzi, WY (Ranking Member) Judd Gregg, NH Lamar Alexander, TN Richard Burr, NC Johnny Isakson, GA Lisa Murkowski, AK Orrin Hatch, UT Pat Roberts, KS Wayne Allard, CO Tom Coburn, OK

Judiciary (as of this writing, subcommittees pending)

Democrats Patrick Leahy, VT (Chair) Edward Kennedy, MA Joseph Biden, DE Herbert Kohl, WI Dianne Feinstein, CA Russ Feingold, WI Charles Schumer, NY Richard Durbin, IL Benjamin Cardin, MD Sheldon Whitehouse, RI

Republicans Arlen Specter (Ranking Member) Orrin Hatch, UT Charles Grassley, IA John Kyl, Arizona Jeff Sessions, AL Lindsey Graham, SC John Cornyn, TX Sam Brownback, TX Tom Coburn, OK

Caucus on International Narcotics Control

Democrats Joseph Biden, DE Diane Feinstein, CA Appointment pending Appointment pending

Republicans Charles Grassley, IA Jeff Sessions, AL Norm Coleman, MN

Subcommittee Rosters - House

Appropriations - Labor, Health and Human Services, Education, and Related Agencies

Democrats David Obey, WI (Chair) Nita Lowey, NY Rosa DeLauro, CT Jesse Jackson, IL Patrick Kennedy, RI Lucille Roybal-Allard, CA Barbara Lee, CA Tom Udall, NM Michael Honda, CA Betty McCollum, MN Tim Ryan, OH

Republicans James Walsh, NY (Ranking Member) Ralph Regula, OH John Peterson, PA Dave Weldon, FL Michael Simpson, ID Dennis Rehberg, MT

Appropriations - Commerce, Justice, Science, and Related Agencies

Democrats Alan Mollohan, WV (Chair) Patrick Kennedy, RI Chaka Fattah, PA C.A "Dutch" Ruppersberger, MD Adam Schiff, CA Michael Honda, CA Rosa DeLauro, CT John Olver, MA

Republicans Rodney Frelinghuysen, NJ John Culberson, TX Harold Rogers, KY Tom Latham, IA Robert Aderholt, AL

Appropriations - Financial Services

Democrats Jose Serrano, NY (Chair) Carolyn Kilpatrick, MI C.A "Dutch" Ruppersberger, MD Debbie Wasserman Schultz, FL Peter Visclosky, IN Robert "Bud" Cramer, Jr., AL Maurice Hinchey, NY Lucille Roybal-Allard, CA

Republicans Ralph Regula, OH Tom Latham, IA Mark Kirk, IL Dennis Rehberg, MT Rodney Alexander, LA

Energy and Commerce - Health

Democrats Frank Pallone, NJ (chair) Henry Waxman, CA Edolphus Towns, NY Bart Gordon, TN Anna Eshoo, CA Gene Green, TX Diana DeGette, CO Lois Capps, CA Tom Allen, ME Tammy Baldwin, WI Eliot Engle, NY Jan Schakowsky, IL Hilda Solis, CA Mike Ross, AK Darlene Hooley, OR Anthony Weiner, NY Jim Matheson, UT

Republicans Nathan Deal, GA (Ranking Member) Ralph Hall, TX Charlie Norwood, GA Barbara Cubin, WY John Shadegg, AZ Steve Buyer, IN Joseph Pitts, PA Mary Bono, CA Mike Ferguson, NJ Mike Rogers, MI Sue Myrick, NC John Sullivan, OK Tim Murphy, PA Michael Burgess, TX

Oversight and Government Reform - Domestic Policy

Democrats Dennis Kucinich, OH (Chair) Tom Lantos, CA Elijah Cummings, MD Diane Watson, CA Christopher Murphy, CT Danny Davis, IL John Tierney, MA Brian Higgins, NY Bruce Braley, IA

Republicans Darrell Issa, CA (Ranking Member) Dan Burton, IN Christopher Shays, CT John Mica, FL Mark Souder, IN Chris Cannon, UT Brian Bilbray, CA

HEARINGS, BRIEFINGS, AND EVENTS OF INTEREST

AAMC-Sponsored Briefing on Addiction
On January 22, 2007, the Association of American Medical Colleges (AAMC) sponsored a Capitol Hill briefing entitled "The Disease of Addiction: New Strategies for Prevention and Treatment." NIDA Director Dr. Nora Volkow updated the audience on recent developments in addiction science, and Dr. Chuck O'Brien from the University of Pennsylvania provided examples from his research to show how basic research can lead to further discovery and, eventually, clinical implementation. This briefing was part of a series that the AAMC started in 2005 to address an unfortunate knowledge gap among Congressional staff about the partnership between the NIH and the nation's medical schools and teaching hospitals.

Meeting with Senate Judiciary staff focusing on Criminal Justice populations
On January 22, NIDA Director Dr. Nora Volkow met with a dozen staff of the Senate Judiciary Committee to discuss the importance of providing addiction treatment to criminal justice populations. This meeting was originally suggested and organized by the Friends of NIDA. Dr. Volkow reviewed the research supporting drug treatment in criminal justice settings, as well as NIDA's "Principals of Drug Abuse Treatment for Criminal Justice Populations. A similar meeting will occur with staff of the House Judiciary Committee.

BILLS OF INTEREST

[For the full text and additional information about any bill, go to the Library of Congress website at http://thomas.loc.gov]

H.R. 3/S.5 - On January 5, 2007, Representative Diana DeGette (D-CO) introduced H.R. 3, the Stem Cell Research Enhancement Act of 2007. The Senate companion, S. 5, was introduced on January 4 by Senate Majority Leader Harry Reid (D-NV). The bills would require the Secretary of HHS to conduct and support research using human embryonic stem cells regardless of the date on which such cells were derived. H.R. 3 had 211 cosponsors upon introduction and was referred to the House Committee on Energy and Commerce; it is expected to be considered by the House on January 11, 2007. S. 5 had 31 cosponsors upon introduction and is expected to be considered by the Senate in February.

H.R. 322/S.51 - On January 4, 2007, Senator Johnny Isakson (R-GA) introduced S. 51, a bill to "derive pluripotent stem cells using techniques that do not knowingly harm embryos." The bill had no cosponsors upon introduction and was referred to the Senate Committee on Health, Education, Labor and Pensions. On January 9, 2007, Representative Roscoe Bartlett (R-MD) introduced the House companion measure, H.R. 322. The bill had 13 cosponsors upon introduction and was referred to the House Committee on Energy and Commerce. The bill would require NIH to fund research to develop techniques for the isolation and production of pluripotent stem cells, without deriving such cells from human embryos.

National Institutes of Health Reform Act of 2006 -- Public Law 109-482

Background
The National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services (DHHS), is the primary Federal agency for conducting and supporting medical research. Comprising 27 Institutes and Centers (ICs), NIH provides leadership and financial support to researchers in every State and around the world. Throughout its history, NIH's ICs, program offices within the Office of the Director (OD), and congressionally directed research programs were regularly reauthorized either through stand-alone or omnibus bills; the last omnibus NIH reauthorization bill was enacted in 1993 (P.L. 103-43). An attempt was made to reauthorize the agency in 1996 when the Senate passed S. 1897, the National Institutes of Health Revitalization Act of 1996; however, the House did not take action on the measure. It should be noted that because Section 301 of the Public Health Service Act provides the Secretary of Health and Human Services (HHS) with permanent statutory authority to conduct and sponsor research, NIH can continue to operate. The annual appropriations process provides a de facto reauthorization for NIH. When Representative Joe Barton (R-TX) became the chair of the House Committee on Energy and Commerce in May 2004, he vowed to reauthorize the agency and held numerous reauthorization and oversight hearings. When crafting legislation, the Chair took into account the 14 recommendations contained in the 2003 Institute of Medicine report entitled "Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges".

Provisions of the Legislation/Impact on NIH In contrast to the last two omnibus reauthorization bills (P.L. 99-158 and P.L. 103-43), which expanded ICs, OD offices, and programs aimed at specific diseases, H.R. 6164 will cap the number of ICs at 27, provide the Director of NIH with expanded authority to manage the agency, encourage ICs to collaborate on trans-NIH research, and reform the agency's reporting system so that Congress can evaluate its research portfolio. Specific provisions of the bill address the following areas:

• Office of the Director: The bill provides the Director of NIH with new oversight and coordination responsibilities across ICs. For example, in consultation with Directors of the ICs, the Director of NIH will be responsible for program coordination across the ICs, including conducting priority-setting reviews, to ensure that NIH's research portfolio is balanced, free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research. The Director of NIH will be require to assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities. The Director will also be required to ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the ICs and that NIH's resources are sufficiently allocated for research projects identified in strategic plans. In coordination with Directors of the ICs, the Director of NIH will be required to ensure that investigator-initiated research is maximized, when appropriate. This portion of the bill contains a provision preserving current authorities of the ICs.
• Reorganization: The bill will reaffirm the Secretary of HHS's authority to reorganize ICs after notifying Congress 180 days in advance. The legislation will require that certain reorganizations be carried out pursuant to a regulatory notice and comment process and with congressional review. In addition, the Director of NIH will be authorized to reorganize the offices within the OD, following a series of public hearings and approval of the Secretary. ICs will be authorized to reorganize their divisions, centers, or other administrative units, including adding, removing, or transferring the functions of such units, following a series of public hearings and approval of the Director of NIH.
• Scientific Management Review Board: The bill will establish a Scientific Management Review Board to conduct periodic organizational reviews. The Board, which must be established within 60 days of enactment, will be required to examine the use of NIH's organizational authorities at least every 7 years, provide a report on its review, and make recommendations regarding the use of such authorities. If the Board recommended an organizational change, the process to effect the change must begin within 100 days of the report, and the change must be fully implemented within 3 years. These requirements do not apply if the Director of NIH objects to all or part of the recommended organizational change within 90 days, and the objection includes a rationale.
• Division of Program Coordination, Planning, and Strategic Initiatives: The bill will establish a new Division of Program Coordination, Planning, and Strategic Initiatives within the OD. The following program offices will be moved within the Division: the Office of AIDS Research, Office of Research on Women's Health, Office of Behavioral and Social Sciences Research, Office of Disease Prevention, Office of Dietary Supplements, and Office of Rare Diseases. The bill contains a provision stating that these offices will retain the authorities in effect prior to enactment of the Act. The Director of NIH, acting through the Division, will be authorized to identify and report on research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between two or more ICs, or would otherwise benefit from strategic coordination and planning. The bill will establish a common fund to pay for such research. The research proposals will be considered by a new Council of Councils, comprising members from IC advisory councils, individuals nominated by OD offices, and members of the Council of Public Representatives. Trans-NIH proposals will be required to include milestones and goals for the research activities and timeframes for funding the research. The bill stipulates that appropriate consideration be given to proposals for which the investigator is a first-time applicant to NIH.
• Common Fund: The Director of NIH will have the authority to allocate Common Fund money to the ICs to fund trans-NIH research. Common Fund amounts will be reserved by the Director and subject to appropriations, but the percentage constituted by the amount reserved relative to the total appropriation in any fiscal year (FY) may not be less than the percentage from the preceding fiscal year. The first year that the Common Fund reached the 5-percent mark, the Director, in consultation with the Council of Councils, will be required to submit recommendations to Congress for changes regarding amounts for the Common Fund.
• Authorization of Appropriations: Expired authorizations of appropriations sections relevant to NIH will be deleted from the statute and replaced with one authorization of appropriations for the entire agency for the following amounts: $30,331,309,000 for FY 2007, $32,831,309,000 for FY 2008, and such sums as may be necessary for FY 2009. Report language accompanying the House-passed bill states that the elimination of other authorizations of appropriations may not be construed as terminating the authority of the IC/OD office to carry out the program. Of the amount authorized to be appropriated for NIH, the bill authorizes for the OD such sums as may be necessary for each of the fiscal years 2007 through 2009.
• Coding System: The bill will require the establishment of an electronic system to uniformly code research grants and activities. This system will be required to be searchable by a variety of codes, such as type of research grant, research entity managing the grant, and public health area of interest. When permissible, the Secretary of HHS, acting through the Director of NIH, will be required to provide information on relevant literature and patents that are associated with NIH's research activities.
• Reporting: ICs will be required to annually report to the Director of NIH the amount of the IC budget made available for trans-NIH research. The appropriations levels of ICs that fail to report trans-NIH funding will be held at the FY 2006 level. The Director of NIH will be allowed to waive the reporting requirement in certain circumstances.
  Most reports pertaining to NIH in current law will be deleted and replaced with one biennial report to Congress, with instructions on the information that will be required to be included. Additional reports with respect to collaboration with other DHHS agencies, clinical trials, human tissue samples, whistleblowers, and experts and consultants will be required. Reports will also be required from each institution receiving an NIH award for the training of graduate students for doctoral degrees.
• Demonstration Programs: The Director of NIH will be authorized, in consultation with the Director of the National Science Foundation, Secretary of the U.S. Department of Energy, and other agency heads, as necessary, to allocate funds for ICs to make grants for interdisciplinary demonstration projects designed to improve public health. The Director of NIH will also be authorized to allocate funds for ICs to make awards of grants or contracts or to engage in other transactions for demonstration projects for high-impact, cutting-edge research; in providing for such research, the Director of NIH or of the IC, as applicable, will be required to seek to facilitate partnerships between public and private entities. Such funds will be allocated from amounts appropriated to the OD. Grant applications must undergo both peer review and advisory council review.
• Foundation for NIH: The bill will make minor technical corrections regarding the Foundation for the NIH Board of Directors, as well as other clarifying amendments. The bill will require NIH to transfer between $500,000 and $1,250,000 to the Foundation annually.

Status and Outlook

A hearing was held on the unnumbered bill on September 19, 2006, and on September 20, 2006, the bill was marked up by the House Committee on Energy and Commerce and passed by a vote of 42 to 1. On September 26, 2006, H. Rept.109-687 was issued, and the bill was introduced as H.R. 6164. It was passed by the House by a vote of 414 to 2. The measure was passed by the Senate with an amendment by unanimous consent on December 8, 2006, and the amended version was passed by the House that same day. The legislation was signed by the President on January 15, 2007, and is cited as Public Law 109-482, the National Institutes of Health Reform Act of 2006.