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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (12)

Short Titles

Short Titles as Enacted for portions of this bill
  • Food Allergen Labeling and Consumer Protection Act of 2004
  • Minor Use and Minor Species Animal Health Act of 2004

Short Titles - House of Representatives

Short Titles as Passed House for portions of this bill
  • Food Allergen Labeling and Consumer Protection Act of 2004
  • Minor Use and Minor Species Animal Health Act of 2004
Short Titles as Reported to House for portions of this bill
  • Food Allergen Labeling and Consumer Protection Act of 2004
  • Minor Use and Minor Species Animal Health Act of 2004

Short Titles - Senate

Short Titles as Passed Senate for portions of this bill
  • Food Allergen Labeling and Consumer Protection Act of 2004
  • Minor Use and Minor Species Animal Health Act of 2004
Short Titles as Reported to Senate for portions of this bill
  • Food Allergen Labeling and Consumer Protection Act of 2003
  • Minor Use and Minor Species Animal Health Act of 2003

Short Titles as Introduced

Minor Use and Minor Species Animal Health Act of 2003

Official Titles

Official Titles - Senate

Official Titles as Introduced

A bill to amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes.


Actions Overview (8)

Date
08/02/2004Became Public Law No: 108-282. (TXT | PDF)
08/02/2004Signed by President.
07/23/2004Presented to President.
07/20/2004Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H6093-6099)
07/15/2004Reported by the Committee on Energy and Commerce. H. Rept. 108-608.
03/08/2004Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
02/18/2004Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg under authority of the order of the Senate of February 12, 2004 with an amendment in the nature of a substitute. With written report No. 108-226.
03/27/2003Introduced in Senate

All Actions (25)

Date Chamber
08/02/2004Became Public Law No: 108-282. (TXT | PDF)
08/02/2004Signed by President.
07/23/2004SenatePresented to President.
07/20/2004-7:21pmHouseMotion to reconsider laid on the table Agreed to without objection.
07/20/2004-7:21pmHouseOn motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H6093-6099)
07/20/2004-7:05pmHouseDEBATE - The House proceeded with forty minutes of debate on S. 741.
07/20/2004-7:05pmHouseConsidered under suspension of the rules. (consideration: CR H6093-6101)
07/20/2004-7:05pmHouseMr. Pickering moved to suspend the rules and pass the bill.
07/15/2004HousePlaced on the Union Calendar, Calendar No. 366.
07/15/2004HouseReported by the Committee on Energy and Commerce. H. Rept. 108-608.
06/24/2004HouseOrdered to be Reported by Voice Vote.
Action By: Committee on Energy and Commerce
06/24/2004HouseCommittee Consideration and Mark-up Session Held.
Action By: Committee on Energy and Commerce
06/15/2004HouseForwarded by Subcommittee to Full Committee by Voice Vote.
Action By: House Energy and Commerce Subcommittee on Health
06/15/2004HouseSubcommittee Consideration and Mark-up Session Held.
Action By: House Energy and Commerce Subcommittee on Health
03/11/2004HouseReferred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
03/09/2004HouseReferred to the House Committee on Energy and Commerce.
03/09/2004-12:30pmHouseReceived in the House.
03/09/2004SenateMessage on Senate action sent to the House.
03/08/2004SenatePassed Senate with an amendment by Unanimous Consent.
03/08/2004SenateThe committee substitute agreed to by Unanimous Consent. (consideration: CR S2365-2375; text of measure as reported in Senate: CR S2365-2374)
02/18/2004SenatePlaced on Senate Legislative Calendar under General Orders. Calendar No. 431.
02/18/2004SenateCommittee on Health, Education, Labor, and Pensions. Reported by Senator Gregg under authority of the order of the Senate of February 12, 2004 with an amendment in the nature of a substitute. With written report No. 108-226.
11/21/2003SenateCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
03/27/2003SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.
03/27/2003SenateSponsor introductory remarks on measure. (CR S4530-4531)

Committees (2)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
Senate Health, Education, Labor, and Pensions03/27/2003 Referred to
11/21/2003 Markup by
02/18/2004 Reported by S. Rept. 108-226
House Energy and Commerce03/09/2004 Referred to
06/24/2004 Markup by
07/15/2004 Reported by H. Rept. 108-608
House Energy and Commerce Subcommittee on Health03/11/2004 Referred to
06/15/2004 Markup by
06/15/2004 Reported by

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.


Latest Summary (6)

There are 6 summaries for S.741. View summaries

Shown Here:
Public Law No: 108-282 (08/02/2004)

(This measure has not been amended since it was reported to the Senate on February 18, 2004. The summary of that version is repeated here.)

Title I: Minor Use and Minor Species Health – Minor Use and Minor Species Animal Health Act of 2004 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act regarding the development of new animal drugs intended for a minor use (defines "minor use" as the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals, or in limited geographic areas and in only a small number of animals annually) or for use in a minor species (any species other than cattle, horses, swine, chickens, turkeys, dogs, and cats).

Allows the Food and Drug Administration (FDA) to award three years of market exclusivity, with full approval, for any new animal drug that requires research to be conducted in the targeted minor species to support such approval.

Creates a conditional approval process for new animal drugs intended for a minor use or for use in a minor species. Requires the same standards for approval as the full approval, except that there must only be a reasonable expectation that the drug is effective for use. (Full approval requires adequate and well-controlled studies to demonstrate by substantial evidence that a new animal drug is effective.) Requires sponsors to commit to conducting additional investigation to meet the full requirements for the demonstration of effectiveness within five years. Establishes that a conditional approval is renewable annually for up to four additional one-year terms upon submission of a request for renewal. Requires labels of such drugs to bear a statement identifying the new animal drug as conditionally approved.

Requires the Secretary of Health and Human Services to establish an index of legally-marketed, unapproved new animal drugs for use in minor species. Provides that this index lists drugs that are not FDA-approved and that are either: (1) not intended for use in animals that will be consumed by humans or by food-producing animals; or (2) not intended for use in early, non-food life stages of food-producing minor species, unless safety for humans has been adequately demonstrated. Specifies labeling requirements for indexed drugs.

Allows the Secretary, before submission of an application for drug approval, to designate new minor use or minor species animal drugs. Provides: (1) grants for such designated drugs for qualified safety and effectiveness testing, and for manufacturing expenses incurred in connection with further development of such drugs; and (2) market exclusivity for such drugs for seven years, with specified exceptions. Requires the Secretary to terminate any such designation if the sponsor discontinues active pursuit of approval.

Directs the Secretary to establish within the Center for Veterinary Medicine of FDA an Office of Minor Use and Minor Species Animal Drug Development to: (1) designate minor use and minor species animal drugs; (2) administer grants and contracts; (3) review minor species drug index listing requests; and (4) serve as a liaison to other government agencies interested in minor use and minor species animal drug development.

Title II: Food Allergen Labeling and Consumer Protection - Food Allergen Labeling and Consumer Protection Act of 2004 - (Sec. 203) Amends the Federal Food, Drug, and Cosmetic Act to require a food that contains, or is derived from, a major food allergen to indicate that information on its label. Defines "major food allergen" as any of the following: milk, eggs, fish, Crustacea, tree nuts, wheat, peanuts, and soybeans. Provides that the labeling requirement must be met by stating the common or usual name of the food allergen in the list of ingredients or by other methods allowed by the Secretary. Requires allergens in flavoring, coloring, or incidental additives to also be labeled in accordance with these requirements.

(Sec. 204) Requires the Secretary to issue a report to Congress that: (1) analyzes the ways in which foods are unintentionally contaminated with major food allergens during manufacturing and processing; (2) estimates how common this contamination is; (3) advises whether good manufacturing practices or other methods can be used to reduce or eliminate this contamination; (4) describes the various types of advisory labels used by food processors, the manufacturing conditions associated with these labels, and the extent to which such labels are used; (5) describes how consumers with food allergies would prefer contamination information to be provided; (6) describes the inspections that have occurred and the violations discovered; and (7) assesses the extent to which contamination has been effectively addressed.

(Sec. 205) Directs the Secretary to inspect facilities to ensure that the facilities comply with practices to reduce or eliminate contamination and properly label food allergens.

(Sec. 206) Requires the Secretary to define and permit use of the term "gluten-free" on food labels.

(Sec. 207) Directs the Secretary, acting through the Director of the Centers for Disease Control, to improve the collection of, and publish national data on, the prevalence of food allergies, the incidence of serious adverse events related to food allergies, and the use of different modes of treatment for and prevention of allergic responses to food. Authorizes appropriations.

(Sec. 208) Requires the Secretary, acting through the Director of the National Institutes of Health, to convene a panel of nationally recognized experts to review basic and clinical research efforts related to food allergies and to recommend ways to enhance and coordinate research activities concerning food allergies.

(Sec. 209) Directs the Secretary, in the Conference for Food Protection, to pursue certain revisions of the Food Code to provide guidelines for preparing allergen-free foods in food establishments.

(Sec. 210) Requires the Secretary to include technical assistance on the use of different modes of treatment for, and prevention of, allergic responses with the technical assistance provided to States and local agencies relating to trauma care and emergency medical services.