S 741 · 108th Congress 2003–2005, ended

Minor Use and Minor Species Animal Health Act of 2003

Introduced Mar 27, 2003 Originated Senate Became Public Law 108-282 Sponsor Jeff Sessions R-AL

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, 2004Public Law 108-282

Summary

Version

(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; 10 are original cosponsors, there from 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
R-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

Show all 21 cosponsors

Committees 2

Where it was sent and what each committee and subcommittee did with it, in order.

Chamber	Committee	What it did
Senate	Health, Education, Labor, and Pensions Committee	Referred Mar 27, 2003Markup Nov 22, 2003Reported Feb 18, 2004
House	Energy and Commerce Committee	Referred Mar 10, 2004Markup Jun 24, 2004Reported Jul 15, 2004
	Health Subcommittee	Referred Mar 11, 2004Markup Jun 15, 2004Reported Jun 15, 2004

Actions 26

Everything that happened, newest first.

Aug 2, 2004Signed by President.
Aug 2, 2004Became Public Law No: 108-282.
Jul 23, 2004Presented to President.
Jul 20, 2004Mr. Pickering moved to suspend the rules and pass the bill.
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.
Jul 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)
Jul 20, 2004Motion to reconsider laid on the table Agreed to without objection.
Jul 15, 2004Reported by the Committee on Energy and Commerce. H. Rept. 108-608.
Jul 15, 2004Placed on the Union Calendar, Calendar No. 366.
Jun 24, 2004Committee Consideration and Mark-up Session Held.
Jun 24, 2004Ordered to be Reported by Voice Vote.
Jun 15, 2004Subcommittee Consideration and Mark-up Session Held.
Jun 15, 2004Forwarded by Subcommittee to Full Committee by Voice Vote.
Mar 11, 2004Referred to the Subcommittee on Health.
Mar 9, 2004Message on Senate action sent to the House.
Mar 9, 2004Received in the House.
Mar 9, 2004Referred to the House Committee on Energy and Commerce.
Mar 8, 2004The committee substitute agreed to by Unanimous Consent. (consideration: CR S2365-2375; text of measure as reported in Senate: CR S2365-2374)
Mar 8, 2004Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Feb 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.
Feb 18, 2004Placed on Senate Legislative Calendar under General Orders. Calendar No. 431.
Nov 21, 2003Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Mar 27, 2003Introduced in Senate
Mar 27, 2003Sponsor introductory remarks on measure. (CR S4530-4531)
Mar 27, 2003Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

In the Congressional Record 4

Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.

Where	In the Record	Members	Date
Extensions	Debate and remarks E1462	Bill Shuster R-PA	Jul 22, 2004
House	Debate and remarks H6093–H6101Text printed H6093–H6099	Bill Shuster R-PA, Charles W. "Chip" Pickering R-MS, George Radanovich R-CA, John D. Dingell D-MI, Nita M. Lowey D-NY	Jul 20, 2004
Senate	Debate and remarks S2365–S2375Text printed S2365–S2374	Don Nickles R-OK, Edward M. Kennedy D-MA	Mar 8, 2004
Senate	Debate and remarks S4530	Jeff Sessions R-AL	Mar 27, 2003

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Committee reports

Congressional Budget Office cost estimates 4

Jul 2, 2004S. 741, An act to amend the Federal Food, Drug, and Cosmetic Act with regard to new animals drugs, and for the other purposes<p>Cost estimate for the bill as ordered reported by the House Energy and Commerce Committee on June 24, 2004</p>
Jul 2, 2004S. 741, An act to amend the Federal Food, Drug, and Cosmetic Act with regard to new animals drugs, and for the other purposesCost estimate for the bill as ordered reported by the House Energy and Commerce Committee on June 24, 2004
Jul 1, 2004S. 741, An act to amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes<p>Cost estimate for the bill as passed by the Senate on March 8, 2004</p>
Jul 1, 2004S. 741, An act to amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposesCost estimate for the bill as passed by the Senate on March 8, 2004

CRS reports 3

Congressional Research Service work that CRS links to this bill or the law it became, newest first.

Cite it 3

Products on other subjects that cite it, usually among other measures.

Product	Title	Kind	Published
R45077	Animal Drug User Fee Programs	Report	Jan 12, 2018
RL34459	Animal Drug User Fee Programs Archived	Report	Aug 4, 2008
RL34334	The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 Archived	Report	Jan 29, 2008

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

Titles 12

Every title it has carried, official and short, at each stage.

Official Title as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes.
Short Titles as Introduced: Minor Use and Minor Species Animal Health Act of 2003
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 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 Passed House for portions of this bill: Minor Use and Minor Species Animal Health Act of 2004; Food Allergen Labeling and Consumer Protection Act of 2004
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 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

Subjects

Assigned by the Library of Congress. Policy area: Animals.

Text 6

Each version as it was printed, newest first.

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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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.