All Food and Drug Administration (FDA) Legislation - Federal Government
S.3385 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.
Latest Action: 07/31/2008 - Sponsor introductory remarks on measure. (CR S7933-7934) Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. 7/31/2008--Introduced. FDA Food Safety Modernization Act - Amends the Federal Food, Drug, and Cosmetic Act to expand the authority of the Secretary of Health and Human Services (the Secretary) to regulate food, including by authorizing the Secretary to: (1) suspend the registration of a food facility; and (2) order a cessation on distribution or recall of food.Directs the Secretary to allocate resources based on the risk profile of food facilities or food.Requires the Secretary and the Secretary of Agriculture to prepare a National Agriculture and Food Defense Strategy.Requires the Administrator of the Environmental Protection Agency (EPA) to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency. Requires the Secretary to: (1) assess fees on domestic food [...] show full description Comment on Bill S.3289 - An original bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2009, and for other purposes.
Latest Action: 07/21/2008 - Committee on Appropriations. Original measure reported to Senate by Senator Kohl. With written report No. 110-426. Bill Text An original bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2009, and for other purposes. 7/21/2008--Reported to Senate without amendment. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2009 - Title I: Agricultural Programs - Appropriates FY2009 funds for the following Department of Agriculture (Department) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) Office of the Chief Economist; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Office of Homeland Security; (6) Office of the Chief Information Officer; (7) Office of the Chief Financial Officer;[...] show full description H.R.6433 - To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.
Latest Action: 07/30/2008 - Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. 7/30/2008--Reported to House amended. (There is 1 other summary) Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.Authorizes appropriations for FY2009-FY2013.Requires the Secretary to report to Congress and make publicly available information [...] show full description H.R.5629 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.
Latest Action: 04/14/2008 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. Bill Text To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 3/13/2008--Introduced. Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product.Prohibits [...] show full description S.CON.RES.70 - An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2009 and including the appropriate budgetary levels for fiscal years 2008 and 2010 through 2013.
Latest Action: 06/05/2008 - Mr. Spratt brought up conference report H. Rept. 110-659 for consideration under the provisions of H. Res. 1214. Bill Text An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2009 and including the appropriate budgetary levels for fiscal years 2008 and 2010 through 2013. 5/20/2008--Conference report filed in House. (There are 4 other summaries) Sets forth the congressional budget for the federal government for FY2009, including the appropriate budgetary levels for FY2008 and FY2010-FY2013. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2008-FY2013, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits (on-budget); (5) debt subject to limit; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security, U.S. Postal Service discretionary administrative expenses, and specified major functional [...] show full description H.R.5219 - To authorize appropriations for the seafood inspection regime of the Food and Drug Administration.
Latest Action: 04/25/2008 - Referred to the Subcommittee on Livestock, Dairy, and Poultry. Bill Text To authorize appropriations for the seafood inspection regime of the Food and Drug Administration. 1/29/2008--Introduced.
Authorizes appropriations to implement the seafood inspection regime of the Food and Drug Administration (FDA). H.R.4083 - To amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes.
Latest Action: 11/06/2007 - Referred to the House Committee on Energy and Commerce. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes. 11/6/2007--Introduced.
Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements. Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress. S.2311 - A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes.
Latest Action: 11/06/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes. 11/6/2007--Introduced.
Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements. Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress. H.R.4076 - To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes.
Latest Action: 11/05/2007 - Referred to the House Committee on Energy and Commerce. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. 11/5/2007--Introduced. Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services within 48 hours after first receiving or becoming aware of [...] show full description H.R.3783 - To direct the Commissioner of Food and Drugs to revise the Federal regulations applicable to the declaration of the trans fat content of a food on the label and in the labeling of the food when such content is less than 0.5 gram.
Latest Action: 10/09/2007 - Referred to the Subcommittee on Health. Bill Text To direct the Commissioner of Food and Drugs to revise the Federal regulations applicable to the declaration of the trans fat content of a food on the label and in the labeling of the food when such content is less than 0.5 gram. 10/9/2007--Introduced.
Trans Fat Truth in Labeling Act of 2007 - Directs the Commissioner of Food and Drugs to promulgate a final regulation revising federal regulations applicable to the declaration of the trans fat content on a food label to require that if the trans fat content of a serving of a food is less than .5 grams and is declared in the nutrition information on the label or in the labeling of the food, such content shall be expressed through the use of an asterisk or other notation stating that such content is less than .5 grams (instead of zero). H.CON.RES.217 - To correct technical errors in the enrollment of the bill H.R. 3580.
Latest Action: 11/08/2007 - Referred to the Subcommittee on Health. Bill Text To correct technical errors in the enrollment of the bill H.R. 3580. 9/25/2007--Passed House without amendment. (There is 1 other summary)
(This measure has not been amended since it was introduced. The summary of that version is repeated here.) Makes corrections in the enrollment of H.R. 3580 (Food and Drug Administration Amendments Act of 2007): (1) to include devices as well as drugs within the scope of provisions regarding an expanded clinical trial registry data bank; and (2) to require that consideration of a citizen petition or a petition for stay of agency action be made separately from review and approval of any application. H.R.3610 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food and drugs imported into the United States, and for other purposes.
Latest Action: 09/26/2007 - Referred to the Subcommittee on Health. Bill Text To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food and drugs imported into the United States, and for other purposes. 9/20/2007--Introduced. Food and Drug Import Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to provide for research on the development of tests and sampling methodologies for use on imported food.Requires the Secretary to assess and collect fees on imported food and drugs.Directs the Secretary to restrict the importation of all food to metropolitan ports of entry with a Food and Drug Administration (FDA) laboratory for testing such food. Deems a food, drug, or device to be misbranded it its labeling fails to identify its country of origin. Requires the Secretary to establish a program under which: (1) persons importing food voluntarily agree to abide by specified food and security guidelines; and (2) the Secretary agrees to [...] show full description H.R.3580 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Latest Action: 09/27/2007 - Signed by President. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...] show full description H.R.3161 - Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2008, and for other purposes.
Latest Action: 08/03/2007 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 331. Bill Text Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2008, and for other purposes. 8/2/2007--Passed House amended. (There are 2 other summaries) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008 - Title I: Agricultural Programs - Appropriates FY2008 funds for the following Department of Agriculture (Department) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) executive operations; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Homeland Security Staff; (6) Office of the Chief Information Officer; (7) Office of the Chief Financial Officer; (8) Office of the Assistant Secretary for Civil Rights; (9) Office of Civil Rights; (10) Office of the Assistant Secretary for Administration; (11) agriculture buildings and facilities [...] show full description H.R.2997 - To require the Secretary of Agriculture and the Commissioner of Food and Drugs to establish a program requiring a certificate of assured safety for imported food items.
Latest Action: 07/16/2007 - Referred to the Subcommittee on Trade. Bill Text To require the Secretary of Agriculture and the Commissioner of Food and Drugs to establish a program requiring a certificate of assured safety for imported food items. 7/11/2007--Introduced. Assured Food Safety Act of 2007 - Directs the Secretary of Agriculture and the Commissioner of Food and Drugs to jointly establish a program to require all food items imported into the United States to bear a certificate of assured safety issued by the government of the country from which the item is imported. Directs the Secretary and the Commissioner to: (1) establish certificate requirements; and (2) prohibit a food item that does not bear such certificate from being imported into the United States. Authorizes specified exemptions. Directs the Secretary and the Commissioner, upon a food item's failure to provide the assured safety level, to prohibit the importation of any similar food item produced by the same person in the same country until the Secretary or the Commissioner [...] show full description H.R.2900 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Latest Action: 07/16/2007 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 270. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 7/11/2007--Passed House amended. (There is 1 other summary) Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems; (2) implementing and enforcing provisions relating to postapproval studies, clinical trials, labeling changes, and risk [...] show full description |
