FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2160), S8651, S8671 [2SE], H5301 [15JY], H5404, H5405 [16JY], H5445, H5447, H5488 [17JY], H5491 [21JY], H5553, H5577, H5578 [22JY], H5665 [23JY], H5677, H5683, H5688, H5689, H5691, H5699, H5708, H5717, H5722, H5723 [24JY]

———making appropriations (H.R. 2160), consideration (H. Res. 193), H5660, H5662 [23JY]

———making appropriations (S. 1033), S7898, S7899, S7901, S7902, S7908, S7912, S7916, S7918, S7925, S7936, S7937, S7945, S7946, S7966, S7967, S7968, S7969 [23JY], S7989, S7990, S7994, S8099 [24JY]

Modernize (S. 830), S9219, S9236 [11SE], S9298 [12SE], S9338, S9340, S9341, S9342, S9343, S9344, S9345, S9346, S9350 [15SE], S9428 [16SE], S9705, S9707 [19SE], S9739, S9763, S9766, S9767 [23SE], S9849 [24SE]

Appointments

Conferees: H.R. 2160, agriculture, rural development, FDA, and related agencies programs appropriations, H6760 [3SE]

———S. 830, FDA Modernization and Accountability Act, S11018 [23OC], H8978 [22OC]

Articles and editorials

Cyclosporiasis and Raspberrries—Lessons for the Future, S9825 [24SE]

Federal Foolishness and Marijuana, E194 [10FE]

Smoking Vote in the Senate, S8678 [3SE]

Bills and resolutions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 1033; H.R. 2160), S7710 [17JY], H5183 [14JY]

———making appropriations (H.R. 2160), consideration (see H. Res. 193), H5569 [22JY]

———making appropriations (H.R. 2160), consideration of conference report (see H. Res. 232), H7599 [18SE]

———making appropriations (H.R. 2160), corrections in enrollment (see H. Con. Res. 167), H8438 [6OC]

Animal Welfare Act: amend and strengthen (see H.R. 635), H392 [6FE]

Diseases: ban use of certain radiopaque dyes in myelograms relative to arachnoiditis prevention (see H.R. 738), H523 [12FE]

Drugs: defer effective dates for approving certain drug applications (see H.R. 1727), H3202 [22MY]

EPA: limit authority to ban metered-dose inhalers (see H.R. 2627), H8633 [7OC]

Federal Food, Drug, and Cosmetic Act: amend medical device provisions (see H.R. 1093), H1111 [18MR]

———classification and performance standards for devices (see H.R. 1527), H2156 [1MY]

———development, clearance, and use of certain devices (see H.R. 1710), H3201 [22MY]

———requirements relative to health claims on food labels (see H.R. 2208), H5569 [22JY]

Federal Food, Drug and Cosmetic Act: improve regulation of food ingredients, nutrient content claims, and health claims (see H.R. 2469), H7262 [11SE]

Government regulations: approval and development of new drugs and biological products (see H.R. 1411), H1793 [23AP]

Health: allow marketing of Sensor Pad medical device to aid in breast self-examination (see H.R. 964), H802 [6MR]

———alternative medical treatments relative to individual access (see S. 578), S3199 [15AP]

———limit authority to ban metered-dose inhalers (see S. 1299), S10882 [21OC]

———proposal to designate the use of chlorofluorocarbons in metered-dose inhalers as nonessential (see H.R. 2221, 2968; H. Con. Res. 113), H5021 [9JY], H5569 [22JY], H10420 [8NO]

Medical devices: facilitate the development and approval process (see S. 870), S5444 [10JN]

Modernize (see S. 830), S5341 [5JN]

Modernize (S. 830): corrections in enrollment (see S. Con. Res. 69; H. Con. Res. 196), S12576 [13NO], H10955 [13NO]

Pharmaceuticals: encourage consultation with pharmacists relative to purchase and use of over-the-counter drug products (see S. Res. 99), S5596 [12JN]

———improve the regulation of drugs (see H.R. 1094), H1111 [18MR]

———incentives for testing the safety of drugs for use by children (see S. 713), S4106 [7MY]

Safety: allow low-dose irradiation of red meat (see H.R. 2480), H7364 [16SE]

Tobacco products: establish Federal authority to regulate tobacco and other products containing nicotine (see H.R. 516), H282 [4FE]

———prevent use by minors, reduce level of addiction, compensate Federal and State governments for tobacco-related illness costs, and enhance biomedical and scientific research (see S. 1492), S12119 [8NO]

———restrict the FDA from penalizing retailers for face-to-face tobacco sales that are in accordance with State law (see H.R. 768), H586 [13FE]

Women: establish offices of women's health within certain Federal agencies (see S. 91; H.R. 920), S161 [21JA], H724 [4MR]

Chronologies

Advanced Breast Biopsy Instrumentation device application process, S9752 [23SE]

Cloture motions

Modernize (S. 830), S8721 [3SE], S8821 [4SE], S8839 [5SE], S9146 [11SE], S9375 [16SE], S9632 [18SE]

Conference reports

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations (H.R. 2160), H7509-H7526 [17SE]

Factsheets

Adverse Health Effects of Feminine Hygiene Products, S9149 [11SE]

FDA Modernization and Accountability Act and Preemption of Cosmetic Regulations by the States, S9149 [11SE]

Hazards of Skin Care Products Containing Alpha-Hydroxy, S9149 [11SE]

Talc May Pose a Risk of Ovarian Cancer, S9150 [11SE]

Letters

Cosmetic industry regulation: Cynthia A. Pearson, National Women's Health Network, S8882 [8SE]

FDA Modernization and Accountability Act: Daniel E. Lungren and Theodora Berger, S8867 [5SE]

———Donna E. Shalala, Sec. of HHS, S8843 [5SE], S9817 [24SE]

———Tom Carper, Governor of Delaware, and Tom Ridge, Governor of Pennsylvania, S8855 [5SE]

FDA regulation of medical device approval process relative to labeling claims: George N. Hatsopoulos, Thermo Electron (business), S9749 [23SE]

———Monica Morrow, S9746 [23SE]

FDA regulation of medical device approval process relative to tracking or conducting of post-market surveillance: Elaine Levenson, Victims Against Lethal Valves (organization), S9708 [19SE]

FDA treatment of liability relative to adverse reaction reports or other certain information: Alan F. Holmer, Pharmaceutical Research and Manufacturers of America, S9765 [23SE]

FDA Youth Anti-Smoking Initiative Enforcement and Outreach Program funding: Vice President Gore, S8652 [2SE]

Food and Drug Administration Modernization and Accountability Act: Donna E. Shalala, Sec. of HHS, S12654-S12656 [13NO]

Food irradiation disclosure requirements: several food and agricultural associations, S9826 [24SE]

NAFTA food safety provisions: several Representatives, E2009 [9OC]

Pharmaceutical and biological prescription drug industries user fees: Donna E. Shalala, Dept. of HHS, H10887 [13NO]

Youth Anti-Smoking Initiative Enforcement and Outreach Program: several State attorneys general, S8653 [2SE]

Lists

Objectionable programs in S. 1033, agriculture, rural development, FDA, and related agencies programs appropriations, S7932-S7934 [23JY]

Objectionable provisions in H.R. 2160, agriculture, rural development, FDA, and related agencies programs appropriations conference report, S11337 [29OC]

Questions relative to review of tobacco settlement: Senator Nickles, S12546 [13NO]

Memorandums

FDA Regulation of Laws on Tobacco Product Labeling, Advertising, and Marketing: Congressional Research Service, S8857-S8859 [5SE]

Motions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2160), H5441, H5443 [17JY], H5707, H5714, H5728, H5730, H5731 [24JY], H6758 [3SE]

———making appropriations (S. 1033), S7910, S7923, S7924, S7929 [23JY], S7988 [24JY]

Modernize (S. 830), H8500 [7OC]

Papers

Human Costs of Regulation—The Case of Medical Devices and the FDA: David C. Murray, Hudson Institution, S9833 [24SE]

Remarks in House

Abbot Laboratories: Intellectual Property Law Association and National Intellectual Property Owners Association Inventors of the Year award recipient, E1397 [10JY]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2160), H5305, H5371-H5382 [16JY], H5408, H5410, H5441-H5448 [17JY], H5551-H5562, H5564 [22JY], H5672-H5732 [24JY], H5813 [25JY], E1474 [22JY], E1491, E1499 [23JY], E1514-E1516 [24JY], E1603 [1AU]

———making appropriations (H.R. 2160), conference report, H8385-H8394 [6OC], E1978 [8OC], E2043 [21OC]

———making appropriations (H.R. 2160), consideration (H. Res. 193), H5650-H5663 [23JY]

———making appropriations (H.R. 2160), consideration of conference report (H. Res. 232), H8383-H8385 [6OC]

———making appropriations (H.R. 2160), motion to instruct conferees, H6758-H6760 [3SE]

———making appropriations (H.R. 2160), unanimous-consent agreement, H5688 [24JY]

Burzynski, Stainislaw: prosecution by FDA relative to medical treatment, H5176 [11JY]

Centers for Disease Control: food safety initiative funding, H7033 [9SE]

Diseases: ban use of certain radiopaque dyes in myelograms relative to arachnoiditis prevention (H.R. 738), E226 [12FE]

Drugs: defer effective dates for approving certain drug applications (H.R. 1727), E1093 [3JN]

———therapeutic use of marijuana, E194 [10FE]

EPA: limit authority to ban metered-dose inhalers (H.R. 2627), H8695 [8OC], H8809 [9OC]

Federal Food, Drug, and Cosmetic Act: classification and performance standards for devices (H.R. 1527), E813 [1MY]

———development, clearance, and use of certain devices (H.R. 1710), E1035, E1043 [22MY]

———requirements relative to health claims on food labels (H.R. 2208), E1471 [22JY]

Government regulations: approval and development of new drugs and biological products (H.R. 1411), H8454, H8455-H8500 [7OC], H8694 [8OC], E2009 [9OC]

Health: proposal to designate the use of chlorofluorocarbons in metered-dose inhalers as nonessential, H8481 [7OC]

———proposal to designate the use of chlorofluorocarbons in metered-dose inhalers as nonessential (H. Con. Res. 113), H4839 [8JY], E1387 [10JY]

———proposal to designate the use of chlorofluorocarbons in metered-dose inhalers as nonessential (H.R. 2221), H8838 [21OC], E1574 [31JY], E1766 [16SE], E2213 [7NO]

———proposal to designate the use of chlorofluorocarbons in metered-dose inhalers as nonessential (H.R. 2968), E2283 [9NO]

Kessler, David: League of Women Voters Carrier Chapman Catt Award recipient, E2351 [13NO]

Leadcare in Office Test System: approval, E1988 [9OC]

Medical devices: facilitate the development and approval process, E83 [9JA]

Modernize (S. 830), H8482-H8500 [7OC], H8807 [9OC]

———conference report, E2388 [13NO]

———corrections in enrollment (H. Con. Res. 196), H10886-H10889 [13NO]

———insert language of H.R. 1411 in lieu, H8500 [7OC]

Personnel: funding, H5684, H5726 [24JY]

Safety: allow low-dose irradiation of red meat (H.R. 2480), H7022 [9SE], H7368 [17SE]

Tobacco products: funding for implementation of regulations concerning sales to minors, H5378 [16JY]

———regulation of tobacco industry to alleviate health risks to children, E2191 [7NO]

———settlement relative to health risks and marketing and manufacturing practices, H3892 [18JN]

———tobacco industry liability settlement relative to health risks and marketing and manufacturing practices, H6722 [3SE], H7533 [18SE], H8043-H8047 [26SE]

———Youth Anti-Smoking Initiative Enforcement and Outreach Program funding, H5561 [22JY], H5656-H5658 [23JY], H5677-H5680, H5725 [24JY], H6758 [3SE]

Women: establish offices of women's health within certain Federal agencies (H.R. 920), E365 [4MR]

Remarks in Senate

Agriculture, rural development, FDA, and related agencies programs: corrections to Senate report, S7896 [23JY]

———making appropriations (H.R. 2160), S8651-S8655 [2SE], S8677-S8682 [3SE]

———making appropriations (H.R. 2160), conference report, S10817 [9OC], S11335-S11339 [29OC], S11398, S11494 [30OC]

———making appropriations (H.R. 2160), corrections in enrollment (H. Con. Res. 167), S11335 [29OC]

———making appropriations (H.R. 2160), unanimous-consent agreement, S8482 [31JY]

———making appropriations (S. 1033), S7893-S7896, S7898-S7946 [23JY], S7987-S8004 [24JY], S8623 [31JY]

———making appropriations (S. 1033), unanimous-consent agreement, S7924, S7934 [23JY]

Cosmetics: regulation of cosmetic industry, S8840-S8842, S8845-S8847, S8860-S8869 [5SE], S8881-S8888, S8892-S8894 [8SE], S9146, S9150 [11SE]

Courts: treatment of liability relative to adverse reaction reports or other certain information, S9764, S9765 [23SE]

Drugs: manufacturing and pharmacy compounding regulations, S9839, S9840, S9849 [24SE]

———prescription drug user fee reauthorization, S7942 [23JY], S8854-S8855, S8860 [5SE], S9838, S9840, S9842, S9844 [24SE]

———revise approval process, S7992 [24JY], S8205 [28JY]

Food: safety of imported fruits and vegetables, S10289 [1OC]

Government: modify mission statement, S9764 [23SE]

Government regulations: approval process and development of new drugs and biological products, S2762-S2764 [7AP]

———Federal requirements for labeling of nonprescription drugs, S9768, S9769 [23SE]

Health: alternative medical treatments relative to individual access (S. 578), S3208 [15AP]

———limit authority to ban metered-dose inhalers (S. 1299), S10876, S10882 [21OC], S11176 [24OC]

———proposal to designate use of chlorofluorocarbons in metered-dose inhalers, S7944 [23JY]

Labeling: food labeling relative to nutrition information, S9824 [24SE]

———revise food irradiation disclosure requirements, S9824, S9825 [24SE]

———uniformity requirements relative to poison control, S9763 [23SE]

Medical devices: facilitate the development and approval process, S9721 [19SE]

———facilitate the development and approval process (S. 870), S5460 [10JN]

———regulation of approval process, S8843-S8845, S8847-S8850, S8853, S8860-S8869 [5SE], S8888-S8890, S8895-S8898 [8SE], S9361, S9380-S9385 [16SE], S9701-S9705 [19SE], S9772-S9775 [23SE], S9831-S9835, S9848 [24SE]

———regulation of approval process devices relative to labeling claims, S9710-S9712 [19SE], S9739-S9754, S9755 [23SE], S9814-S9819, S9827-S9831 [24SE]

———regulation of approval process relative to conflict of interest standards of FDA employees, S9705-S9707 [19SE], S9737, S9738 [23SE]

———regulation of approval process relative to tracking or conducting of post-market surveillance, S9708-S9710 [19SE], S9738, S9739 [23SE]

Modernize (S. 830), S5342 [5JN], S8162-S8170, S8205 [28JY], S8482 [31JY], S8721 [3SE], S8815 [4SE], S8837-S8869 [5SE], S8878-S8898 [8SE], S9133-S9157 [11SE], S9360-S9363, S9378-S9385 [16SE], S9553, S9694-S9697 [18SE], S9701-S9713, S9721 [19SE], S9737-S9754, S9755-S9759-S9769, S9771-S9775, S9781 [23SE], S9811-S9868 [24SE], S10469 [7OC]

———conference report, S12482 [10NO], S12653 [13NO]

———corrections in enrollment (S. Con. Res. 69), S12710 [13NO]

———unanimous-consent agreement, S8819 [4SE], S9362, S9378 [16SE], S9600, S9626 [18SE], S9754, S9759, S9760, S9769 [23SE], S10777 [9OC]

NIH: osteoporosis prevention and treatment programs funding, S9111, S9112 [11SE]

Pharmaceuticals: encourage consultation with pharmacists relative to purchase and use of over-the-counter drug products (S. Res. 99), S5626 [12JN]

———establish financial incentives for testing the safety of drugs on children, S9823 [24SE]

———incentives for testing the safety of drugs for use by children (S. 713), S4276, S4281 [9MY]

States: issuance of warning labels or public warnings about over-the-counter drugs, S9844, S9845 [24SE]

Tobacco products: prevent use by minors, reduce level of addiction, compensate Federal and State governments for tobacco-related illness costs, and enhance biomedical and scientific research (S. 1492), S12163-S12179 [8NO]

———regulation, S9766, S9767 [23SE]

———regulation of tobacco industry to alleviate health risks to children, S1800 [28FE], S12543-S12546 [13NO]

———settlement relative to health risks and marketing and manufacturing practices, S3703 [25AP]

———tobacco industry liability settlement relative to health risks and marketing and manufacturing practices, S8853, S8856, S8859 [5SE], S9246-S9248 [12SE], S12543-S12546 [13NO]

———tobacco industry liability settlement relative to health risks and marketing and manufacturing practices (S. 1414), S12209 [8NO]

———Youth Anti-Smoking Initiative Enforcement and Outreach Program funding, S7912-S7924, S7929, S7930 [23JY]

Women: establish offices of women's health within certain Federal agencies (S. 91), S470 [21JA]

Youth Anti-Smoking Initiative Enforcement and Outreach Program: funding, S8652 [2SE], S8678-S8682, S8720 [3SE]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee of Conference (H.R. 2160) (H. Rept. 105-252), H7527 [17SE]

———Committee on Appropriations (House) (H.R. 2160) (H. Rept. 105-178), H5183 [14JY]

———Committee on Appropriations (Senate) (S. 1033) (S. Rept. 105-51), S7708 [17JY]

Consideration of Conference Report on H.R. 2160, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 232) (H. Rept. 105-255), H7599 [18SE]

Consideration of H.R. 2160, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 193) (H. Rept. 105-197), H5569 [22JY]

FDA Modernization and Accountability Act: Committee on Labor and Human Resources (Senate) (S. 830) (S. Rept. 105-43), S6907 [7JY]

FDA Regulatory Modernization Act: Committee on Commerce (House) (H.R. 1411) (H. Rept. 105-310), H8632 [7OC]

Food and Nutrition Information Reform Act: Committee on Commerce (House) (H.R. 2469) (H. Rept. 105-306), H8437 [6OC]

Medical Device Regulatory Modernization Act: Committee on Commerce (House) (H.R. 1710) (H. Rept. 105-307), H8437 [6OC]

Reports to constituents

Hamilton, Representative: Is Your Supper Safe? U.S. Food Safety Policy, E1839 [24SE]

Resolutions by organizations

Tobacco Industry Settlement: Chicago, IL, City Council, E2191 [7NO]

Rulings of the Chair

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2160), H5687, H5688 [24JY]

Statements

FDA Modernization and Accountability Act (S. 830): Committee on Labor and Human Resources (Senate), S9835-S9838 [24SE]

———OMB, S9848, S9849 [24SE]

Regulation of Cosmetic Industry in Food and Drug Administration Modernization and Accountability Act: David Wallinga, Natural Resources Defense Council, S9148 [11SE]

Summaries

Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures, H10887-H10889 [13NO]

Tables

Agriculture, rural development, FDA, and related agencies programs appropriations, H8386-H8392 [6OC]

Committee on the Budget (Senate) scoring of H.R. 2160, Dept. of Agriculture, rural development, FDA, and related agencies appropriations conference report, S11337 [29OC]

Committee on the Budget (Senate) scoring of S. 1033, agriculture, rural development, FDA, and related agencies programs appropriations, S7942 [23JY]

Testimonies

Biomedical Research Funding Relative to Market Exclusivity: Scott Hallquist, Immunex Corp., E2120 [29OC]

Texts of

H. Con. Res. 167, corrections in enrollment of H.R. 2160, agriculture, rural development, FDA, and related agencies programs appropriations, H8385 [6OC]

H. Con. Res. 196, corrections in enrollment of S. 830, Food and Drug Administration Modernization and Accountability Act, H10886 [13NO]

H. Res. 193, consideration of H.R. 2160, agriculture, rural development, FDA, and related agencies programs appropriations, H5650 [23JY]

H. Res. 232, consideration of conference report on H.R. 2160, agriculture, rural development, FDA, and related agencies programs appropriations, H8383 [6OC]

H.R. 1411, FDA Regulatory Modernization Act, H8455-H8474 [7OC]

S. 578, Access to Medical Treatment Act, S3209 [15AP]

S. 830, FDA Modernization and Accountability Act, S9133-S9145 [11SE], S9850-S9867 [24SE], H8482-H8500 [7OC]

S. 870, Medical Technology, Public Health, and Innovation Act, S5461-S5463 [10JN]

S. 1033, agriculture, rural development, FDA, and related agencies programs appropriations, S7995-S8003 [24JY]

S. 1299, Asthma Inhaler Regulatory Relief Act, S10883 [21OC]

S. 1492, Healthy and Smoke Free Children Act, S12164-S12178 [8NO]

S. Con. Res. 69, corrections in enrollment of S. 830, Food and Drug Administration Modernization and Accountability Act, S12616, S12710 [13NO]

S. Res. 99, encourage consultation with pharmacists relative to purchase and use of over-the-counter drug products, S5626 [12JN]