Minor Use and Minor Species Animal Health Act of 2003
Latest action · Aug 2, 2004 Became Public Law No: 108-282.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 27, 2003
- Passed SenateMar 8, 2004
- Passed HouseJul 20, 2004
- To the PresidentJul 23, 2004
- Became lawAug 2, 2004
Summary
(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.
Cosponsors 21
Members who signed on, in the order they did. Signatures ran from Mar 27, 2003 to Feb 25, 2004, with 10 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-AR | Blanche L. Lincoln | Original | Mar 27, 2003 |
| D-NM | Jeff Bingaman | Original | Mar 27, 2003 |
| R-NV | John Ensign | Original | Mar 27, 2003 |
| R-NH | Judd Gregg | Original | Mar 27, 2003 |
| R-ID | Larry E. Craig | Original | Mar 27, 2003 |
| R-ID | Mike Crapo | Original | Mar 27, 2003 |
| R-ME | Susan M. Collins | Original | Mar 27, 2003 |
| D-IA | Tom Harkin | Original | Mar 27, 2003 |
| R-CO | Wayne Allard | Original | Mar 27, 2003 |
| D-GA | Zell Miller | Original | Mar 27, 2003 |
| D-AL | Richard C. Shelby | Apr 10, 2003 | |
| R-NM | Pete V. Domenici | May 13, 2003 | |
| R-WY | Michael B. Enzi | May 14, 2003 | |
| R-OR | Gordon H. Smith | May 22, 2003 | |
| D-WA | Patty Murray | Jul 9, 2003 |
Actions 28
Everything that happened, newest first.
- Aug 2, 2004Became Public Law No: 108-282.
- Aug 2, 2004Signed by President.
- Jul 23, 2004Presented to President.
- Jul 20, 2004Considered under suspension of the rules. (consideration: CR H6093-6101)
- Jul 20, 2004DEBATE - The House proceeded with forty minutes of debate on S. 741.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 2079 | Minor Use and Minor Species Animal Health Act of 2003 | Related bill | May 20, 2003 |
Subjects
Assigned by the Library of Congress. Policy area: Animals.
- Administrative procedure
- Administrative remedies
- Agriculture and Food
- Allergies
- Animals
- Business records
- Civil Rights and Liberties, Minority Issues
- Clinical trials
- Commerce
- Conferences
- Congress
- Congressional reporting requirements
- Consumer education
- Department of Health and Human Services
- Drug approvals
- Drug industry
- Drugs
- Economics and Public Finance
- Environmental assessment
- Environmental Protection
- Executive reorganization
- Federal aid to research
- Feeds
- Food additives
- Food industry
- Food safety
- Food service
- Fraud
- Freedom of information
- Government Operations and Politics
- Government paperwork
- Government publications
- Government publicity
- Health
- Intellectual property
- Judicial review
- Labeling
- Law
- Marketing
- Medical research
- Milk
- Names
- Nuts
- Orphan drugs
- Patents
- Peanuts
- Pharmaceutical research
- Poultry
- Preventive medicine
- Protection of animals
- Restaurants
- Science, Technology, Communications
- Seafood
- Soybeans
- Veterinary medicine
- Wheat
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.