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Legislative Update June 2007

Diseases of the Heart, Lungs, Blood, or Blood Vessels

  • Comprehensive Tuberculosis Elimination Act of 2007 (H.R. 1532)
  • Heart Disease Education, Analysis and Research, and Treatment for Women Act (H.R. 1014 and S. 573)

Stem Cell Research

  • Stem Cell Research Enhancement Act of 2007 (S.977)

Genetics and Genomics

  • Genomics and Personalized Medicine Act of 2007 (S. 976)
  • Genomic Research and Accessibility Act (H.R. 977)

Clinical Research

  • Enhancing Drug Safety and Innovation Act of 2007 (H.R. 1561)
  • Fair Access to Clinical Trials Act of 2007 (S. 467)
  • Pediatric Medical Device Safety and Improvement Act of 2007 (H.R. 1494 and S. 830)

Health Care

  • American Health Security Act of 2007 (H.R. 1200)

Animal Research

  • Pet Safety and Protection Act of 2007 (H.R. 1280 and S. 714)

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Diseases of the Heart, Lungs, Blood, or Blood Vessels

Comprehensive Tuberculosis Elimination Act of 2007

Number: H.R. 1532

Sponsor: Representative Gene Green (D-TX)

Referred to: House Committee on Energy and Commerce

Highlights: Would require the Director, NHLBI, to expand, intensify, and coordinate research and development and related activities of the Institute regarding tuberculosis (TB), and authorize the Director to provide awards to faculty of schools of medicine and osteopathic medicine for curricula development and awards to support the career development of clinically trained professionals committed to research on pulmonary infections and TB. The bill would also amend Sec. 447A, Public Health Service Act, to require the National Institute of Allergy and Infectious Diseases to include development of a TB vaccine within its related research activities; and would require the Fogarty International Center to expand, intensify, and coordinate its international activities with respect to TB research and training.

Heart Disease Education, Analysis and Research, and Treatment for Women Act

Number: S.573 and H.R. 1014

Sponsor: Senator Debbie Stabenow (D-MI) and Representative Lois Capps (D-CA)

Referred to: Senate Committee on Health Education, Labor, and Pensions; House Committee on Energy and Commerce

Highlights: Would require that information reported to the FDA for new drug applications and investigational new drug applications be stratified by sex and ethnicity. Would require the Secretary, HHS to report annually on findings related to quality of and access to care for women with cardiovascular disease. Would also require the Secretary, HHS to develop and distribute educational materials about prevention, diagnosis, and treatment of cardiovascular disease to women over 65 and physicians and other healthcare professionals.

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Stem Cell Research

Stem Cell Research Enhancement Act of 2007

Number: S. 997

Sponsor: Senator Tom Harkin (D-IA)

Highlights: The bill is an amended version of S. 5, and 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. The bill would also require the Secretary to conduct and support research involving methods of obtaining pluripotent stem cells that do not involve the use of human embryos.

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Genetics and Genomics

Genomics and Personalized Medicine Act of 2007

Number: S. 976

Sponsor: Senator Barack Obama (D-IL)

Referred to: Senate Committee on Health, Education, Labor and Pensions

Highlights: Would require the Secretary of HHS to establish the Genomics and Personalized Medicine Interagency Working Group (IWG). Among other duties, the IWG would develop guidelines for procedures, protocols, and policies safeguarding the privacy of biobank subjects, in accordance with the Office for Human Research Protections and Clinical Research Policy Analysis and Coordination Program at the NIH. S. 976 would also authorize the Secretary to establish a national biobanking database; a biobank initiatives grant program; and a mechanism for management and submission of pharmacogenomic data developed by the FDA in collaboration with the NIH and CDC. The Secretary would conduct studies in order to realize the potential of personalized medicine by accelerating genomic research, increasing understanding of how genomics interacts with environmental factors to cause disease, and accelerating development of accurate diagnostics and treatments.

Genomic Research and Accessibility Act

Number: H.R. 977

Sponsor: Representative Xavier Becerra (D-CA)

Referred to: House Committee on the Judiciary

Highlights: Would amend title 35, United States Code, to prohibit the patenting of human genetic material.

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Clinical Research

Enhancing Drug Safety and Innovation Act of 2007

Number: H.R. 1561

Sponsor: Representative Henry Waxman (D-CA)

Referred to: House Committee on Energy and Commerce

Highlights: Would modify procedures at FDA regarding the approval of drugs. Title III of the bill would require NIH to expand ClinicalTrials.gov to include a broader registry of clinical trials. The bill would also require NIH to establish a "results" database that would require sponsors of clinical trials to submit results of those clinical trials included in the registry, accompanied by a narrative summary describing those results.

Fair Access to Clinical Trials Act of 2007

Number: S. 467

Sponsor: Senator Christopher Dodd (D-CT)

Referred to: Senate Committee on Health, Education, Labor and Pensions

Highlights: Would require the expansion of ClinicalTrials.gov to include a results database.

Pediatric Medical Device Safety and Improvement Act of 2007

Number: S. 830 and H.R. 1494

Sponsor: Senator Christopher Dodd (D-CT) and Representative Edward Markey (D-MA)

Referred to: Senate Committee on Health, Education, Labor and Pensions; House Committee on Energy and Commerce

Highlights: Would require NIH, FDA, and AHRQ to develop a plan for expanding medical device research and development. Provisions would also require the Secretary, HHS, to provide grants to a non-profit consortium, which would be tasked with facilitating the development of pediatric devices, by connecting individuals with ideas for pediatric devices with potential manufacturers. The consortium would be required to coordinate with NIH in these efforts and would be responsible for notifying NIH of any unmet needs that the consortium lacks sufficient capacity to address.

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Health Care

American Health Security Act of 2007

Number: H.R. 1200

Sponsor: Representative Jim McDermott (D-WA)

Referred to: House Committees on Energy and Commerce; House Committee on Ways and Means; House Oversight and Government Reform Committee; and House Armed Services Committee

Highlights: The purpose of the bill is "to provide for health care for every American and to control the cost and enhance the quality of the health care system." Of interest to NIH is section 722, which would establish the Office of Primary Care and Prevention Research within the Office of the Director; require the establishment of a data system of information regarding primary care and prevention research that is conducted or supported by the NIH; require the establishment of a clearinghouse to provide information on research and prevention activities of the NIH that relate to primary care and prevention research; and require a biennial report on primary care and prevention research.

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Animal Research

Pet Safety and Protection Act of 2007

Number: S. 714 and H.R. 1280

Sponsor: Senator Daniel Akaka (D-HI) and Representative Michael Doyle (D-PA)

Referred to: Senate Committee on Agriculture, Nutrition, and Forestry; House Committee on Agriculture

Highlights: Would amend the Animal Welfare Act to list permissible sources of dogs and cats used by research facilities to include dogs and cats obtained 1) from a licensed dealer, 2) from a publicly owned and operated pound or shelter that meets specified requirements, 3) by donation from the person who bred and raised the dog or cat and owned it for not less than 1 year, or 4) from a research facility licensed by the Secretary of Agriculture. It would increase monetary penalties for related violations and would expressly prohibit Federal facilities from purchasing or otherwise acquiring dogs or cats for exhibition purposes, except from 1) the operator of an auction that comports with legal requirements or 2) a person holding a valid dealer or exhibitor license. The bill would also prohibit dealers from selling to or otherwise providing a research facility with random-source dogs or cats unless specified certification requirements were met.

 
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