3.0.0 5306 2023-01-14T22:48:40Z 2023-01-14T22:48:40Z House H HR 2004-10-08 108 hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2004-11-05T17:10:12Z Referred to 2004-10-08T13:01:35Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2004-10-08T19:06:59Z Referred to 2004-10-08T13:01:30Z 2004-11-05 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. Committee 2004-10-08 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2004-10-08 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2004-10-08 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100-A 9 Library of Congress 2004-10-08 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2004-10-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2004-10-08 Introduced in House IntroReferral 1000 9 Library of Congress C001051 Rep. Carter, John R. [R-TX-31] John Carter R TX R. 31 N Health Administrative procedure Cancer Clinical trials Commerce Department of Health and Human Services Drug approvals Drug industry Drugs Government Operations and Politics Government paperwork Intellectual property Law Licenses Patents Pharmaceutical research Science, Technology, Communications Health 00 2004-10-08 Introduced in House 2005-01-06T20:58:18Z New War on Cancer Act - Allows the sponsor of a drug intended for use for cancer to request the Secretary of Health and Human Services to: (1) provide written recommendations for investigations which must be conducted before approval of a drug or before licensure of a biological product for use for cancer; and (2) designate such drug as a cancer drug before the submission of a request for approval or licensing. Requires the Secretary to designate such drug as a cancer drug if the drug is being or will be investigated for use for cancer. Prohibits the Secretary from approving another application or issuing another license for a designated cancer drug for a person who is not the holder of the approved application or license until the expiration of seven years, with certain exceptions.

Requires the Secretary to encourage the sponsor of a designated cancer drug approved for investigational use to design protocols for the drug that include persons with the cancer involved who cannot be satisfactorily treated by alternative drugs.

Extends the time during which an application for approval of drug with the same active ingredient as an approved cancer drug may not be approved.

Excludes approved cancer drugs from time limits imposed on the maximum length of a patent.

]]> New War on Cancer Act Display Title New War on Cancer Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for cancer drugs, and to amend title 35, United States Code, to provide for the extension of the patent term on such drugs equal to the regulatory review period for such drugs. Introduced in House IH Short Titles as Introduced New War on Cancer Act Introduced in House 2004-10-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-108hr5306ih/xml/BILLS-108hr5306ih.xml 2004-11-05 Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.