Genomics and Personalized Medicine Act of 2008
Latest action (15 Jul 2008): Introduced
What this bill does
This bill, introduced in the House on July 15, 2008, aims to expand federal support for "personalized medicine" — the use of genetic and genomic information to guide diagnosis, drug selection, and treatment. It would direct the Secretary of Health and Human Services to create an interagency working group to coordinate genomics research, set data and privacy standards, and recommend a national biobank database. It also authorizes a national biobanking distributed database and a grant program for academic medical centers and other entities to build or expand biobanks collecting genetic, environmental, and clinical data. Additional provisions fund genetics/genomics training for health professionals and direct the FDA to establish a public registry tracking the analytical and clinical validity of laboratory-developed genetic tests.
The bill would primarily affect federal health agencies (HHS, NIH, CDC, FDA, CMS, and others named as working-group members), academic and research institutions applying for biobank or training grants, healthcare providers seeking genomics training, and laboratories developing genetic tests, which would face new reporting requirements to the FDA. It cites specific funding authorizations, including $5 million for the interagency working group, $150 million for genomics research and biobanking in FY2009, and $10 million for workforce training in FY2009, with additional sums for later years.
The bill was referred to the House Committees on Energy and Commerce and Ways and Means. It did not receive a vote and did not advance further in the 110th Congress.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
Genomics and Personalized Medicine Act of 2008 - Directs the Secretary of Health and Human Services to: (1) establish the Genomics and Personalized Medicine Interagency Working Group (IWG) to facilitate collaboration, coordination, and integration of activities among federal agencies relating to genomic research and initiatives; (2) expand and accelerate research and programs to collect genetic and genomic data that will advance the field of genomics and personalized medicine; (3) establish a national biobanking distributed database for the collection and integration of genomic data and associated environmental and clinical health information; (4) establish a grant program for academic medical centers and other entities to develop or expand biobanking initiatives; (5) improve genetics and genomics training for diagnosis, treatment, and counseling of adults and children for both rare and common disorders; (6) establish a registry on the analytical and clinical validity of laboratory-developed genetic tests; (7) contract with the National Academy of Sciences to study incentives to encourage companion diagnostic test development; and (8) make information available on the safety and efficacy of genetic tests and commission a study for improving federal oversight and regulation of such tests.
Requires the Director of the Centers for Disease Control and Prevention (CDC) to: (1) conduct an analysis of the public health impact of direct-to-consumer marketing of genetic tests; and (2) expand efforts to educate the public about genomics and its health applications.
Amends the Internal Revenue Code to establish a companion diagnostic tax credit for qualified diagnostic tests designed to provide information that can be used to increase the safety or effectiveness of a drug.
Common questions
- What does H.R. 6498 do?
- This bill, introduced in the House on July 15, 2008, aims to expand federal support for "personalized medicine" — the use of genetic and genomic information to guide diagnosis, drug selection, and treatment. It would direct the Secretary of Health and Human Services to create an interagency working group to coordinate genomics research, set data and privacy standards, and recommend a national biobank database. It also authorizes a national biobanking distributed database and a grant program for academic medical centers and other entities to build or expand biobanks collecting genetic, environmental, and clinical data. Additional provisions fund genetics/genomics training for health professionals and direct the FDA to establish a public registry tracking the analytical and clinical validity of laboratory-developed genetic tests. The bill would primarily affect federal health agencies (HHS, NIH, CDC, FDA, CMS, and others named as working-group members), academic and research institutions applying for biobank or training grants, healthcare providers seeking genomics training, and laboratories developing genetic tests, which would face new reporting requirements to the FDA. It cites specific funding authorizations, including $5 million for the interagency working group, $150 million for genomics research and biobanking in FY2009, and $10 million for workforce training in FY2009, with additional sums for later years. The bill was referred to the House Committees on Energy and Commerce and Ways and Means. It did not receive a vote and did not advance further in the 110th Congress.
- Has H.R. 6498 become law?
- Not yet. As of 15 Jul 2008, H.R. 6498 is introduced.
- Who sponsored H.R. 6498?
- H.R. 6498 was sponsored by Rep. Patrick Kennedy [D-RI1, 1995-2010] (Democrat-RI), with 0 cosponsors.
- What's the latest action on H.R. 6498?
- Introduced (15 Jul 2008).
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