FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2330), S11065, S11071, S11076, S11080, S11089, S11090, S11091, S11116, S11125, S11126, S11127, S11128, S11129, S11130 [25OC], S11236, S11247 [30OC], H3520 [25JN], H3619, H3620 [26JN], H3714, H3715 [27JN], H3761, H3765, H3767, H3770, H3774, H3775, H3777, H3779, H3781, H3784, H3807, H3808 [28JN], H3864 [10JY], H3877, H3878, H3879, H3880, H3889, H3890, H3897, H3901, H3903, H3906, H3907, H3908, H3909, H3911, H3915, H3917, H3918, H3921, H3922, H3961 [11JY]

Dept. of Agriculture: require a report on coordinated actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease (S. 700), S3623 [5AP]

Pharmaceuticals: improve safety and efficacy for children (S. 838), S10816, S10844, S10848 [18OC]

Appointments

Conferees: H.R. 2330, agriculture, rural development, FDA, and related agencies programs appropriations, S11095 [25OC], H7553 [31OC]

Articles and editorials

Cannibals to Cows—The Path of a Deadly Disease, S2317 [14MR]

Could Mad Cow Reach America?, S2316 [14MR]

Daloa, Ivory Coast, H3782 [28JN]

``Full Disclosure'' Standard in TMJ Approval Opens New FDA Era, H3760 [28JN]

Meat From Europe Is Banned by U.S. as Illness Spreads, S2318 [14MR]

New Tools May Make Heart-Bypass Surgery Quicker and Less Risky, E995 [26MY]

Toughest Device Approval Clears Last of Embattled Firm's Implants, H3761 [28JN]

U.S. Adds to Ban on European Meats—Foot-and-Mouth Epidemic Is Cited, S2317 [14MR]

Bills and resolutions

Agriculture: prohibit products containing dry ultra-filtered milk or casein from being labeled domestic natural cheese (see S. 117), S100 [22JA] (see H.R. 1016), H927 [14MR]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 1191), S7878 [18JY] (see H.R. 2330), H3711 [27JN]

———making appropriations (H.R. 2330), consideration (see H. Res. 183), H3713 [27JN]

Animals: establish a Federal task force to coordinate actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease (see S. 534), S2306 [14MR]

———increase the availability of drugs for minor species and rare diseases in all animals (see H.R. 1956), H2678 [23MY]

Children and youth: amend certain laws relative to pediatric studies of drugs (see H.R. 3047), H6379 [4OC]

Dept. of Agriculture: require a report on coordinated actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease (see S. 700), S3436 [4AP] (see S. 708), S3530 [5AP]

Dept. of HHS: antimicrobial resistance activities in the interagency public health action plan (see H.R. 1771), H2081 [9MY]

———establish an Office on Women's Health (see S. 946), S5615 [24MY] (see H.R. 1784), H2082 [9MY]

Drugs: correct impediments to allowing importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use (see H.R. 58), H26 [3JA]

———discrepancy in prescription drug prices between U.S. and foreign countries (see H. Res. 26), H166 [31JA]

———distribution chain of prescription drugs (see S. 1132), S7083 [28JN]

———enhance competition for prescription drugs by increasing enforcement of existing antitrust laws relative to brand name and generic drugs (see H.R. 1530), H1498 [4AP]

———permit individuals to import prescription drugs in limited circumstances (see S. 1229), S8123 [24JY]

———regulate receipt of donated prescription drug samples by charitable health care entities (see H.R. 2740), H5334 [2AU]

Federal Food, Drug, and Cosmetic Act: amend relative to clinically superior modifications to previously approved or licensed drugs (see H.R. 386), H165 [31JA]

———amend relative to new animal drugs (see S. 1346), S8705 [2AU]

———improve regulation of medical devices (see H.R. 3580), H10964 [20DE]

———provide greater access to affordable pharmaceuticals (see S. 812), S4100 [1MY] (see H.R. 1862), H2280 [16MY]

Fish and fishing: provide clarification regarding the market name for the fish Pangasius bocourti and compliance with the Federal Food, Drug, and Cosmetic Act (see S. 1494), S10154 [3OC] (see H.R. 2964), H6055 [25SE]

Food: consumer access to information on the health benefits of foods and dietary supplements (see H.R. 2265), H3463 [21JN]

Food industry: require Dept. of Agriculture report on safety and monitoring of genetically engineered foods (see H.R. 713), H398 [14FE]

Food Safety Administration: establish as independent agency to consolidate food safety, labeling, and inspection functions (see S. 1501), S10287 [4OC] (see H.R. 1671), H1715 [1MY]

Government regulations: establish labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors (see H.R. 3066), H6458 [9OC]

Health: allow access to drugs and medical devices recommended and provided by health care practitioners that are not approved by the FDA (see S. 1378), S8911 [3AU] (see H.R. 1964), H2678 [23MY]

Health care professionals: establish restrictions relative to the qualifications of physicians prescribing the abortion drug known as RU-486 (see S. 251), S1062 [6FE] (see H.R. 482), H221 [7FE]

Pharmaceuticals: ensure prompt research, development, and distribution of new drugs, biologics, and medical devices that prevent or mitigate the consequences of a chemical or biological terrorist attack (see S. 1635), S11488 [6NO] (see H.R. 3457), H9239 [11DE]

———establish therapeutic equivalence requirements for generic drugs (see H.R. 1685), H1860 [2MY]

———importation of certain prescription drugs by pharmacists and wholesalers (see H.R. 698), H397 [14FE]

———improve safety and efficacy for children (see S. 838), S4416 [7MY] (see S. 1301), S8575 [1AU] (see S. 1789), S12682 [7DE] (see H.R. 2887), H5615 [13SE] (see H.R. 3452), H9239 [11DE]

———permit import of prescription medications sold in certain foreign countries and correct impediments in implementation of the Medicine Equity and Drug Safety Act (see S. 215), S707 [30JA]

———provide access and choice for use of generic drugs under Federal health care programs (see S. 186), S568 [25JA]

Safety: ensure protection of the U.S. food supply (see S. 1551), S10693 [15OC] (see H.R. 3184), H7529 [30OC]

———establish a comprehensive program to ensure food safety (see H.R. 1817), H2141 [10MY]

———improve safety of imported foods (see S. 1634), S11437 [5NO] (see H.R. 3075), H6504 [10OC]

———require manufacturers of dietary supplements to register and require submission of reports on adverse experiences regarding such supplements (see H.R. 3065), H6458 [9OC]

———uniform food safety warning notification requirements (see H.R. 2649), H4723 [26JY]

Taxation: treatment of direct-to-consumer advertisements of prescription drugs that fail to provide certain information to the consumer (see H.R. 2352), H3712 [27JN]

Tobacco products: grant authority to regulate tobacco (see S. 190), S568 [25JA] (see S. 247), S1062 [6FE] (see H.R. 1043), H953 [15MR] (see H.R. 1097), H1010 [20MR] (see H.R. 2180), H3201 [14JN]

Women: promote research and disseminate information on the health effects of breast implants and encourage FDA review of implant manufacturers (see S. 961), S5616 [24MY] (see H.R. 1961), H2678 [23MY]

———protect breastfeeding by new mothers, establish performance standard for breast pumps, and allow tax credit for enabling mothers to breastfeed or express milk at work (see H.R. 285), H110 [30JA]

Conference reports

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations (H.R. 2330), H7962-H7986 [9NO]

Letters

FDA premarket approval application review process of TMJ Implants, Inc.'s, total and partial joint prostheses: Roland Jankelson, E15 [3JA]

Importation of prescription drugs into the U.S. by U.S. citizens for personal use: William B. Simpkins, DEA, H3892, H3895 [11JY]

———William K. Hubbard, FDA, H3893 [11JY]

Insurance coverage for individuals participating in approved clinical trials: Cancer Leadership Council, S6587 [21JN]

———Daniel E. Smith, American Cancer Society, S6583, S6587 [21JN]

Women's Health Office Act: several health organizations, S5620 [24MY]

Lists

Cancer Leadership Council, S6588 [21JN]

Memorandums

Acceptable Market Names for Fish in the Catfish Family: Scott Rippey, Dept. of HHS, S11337 [1NO]

Approval of Generic Versions of Drugs Without Pediatric Labeling, H10209 [18DE]

———Laurence H. Tribe, E2286-E2288 [13DE]

———Wilmer, Cutler & Pickering (law firm), H8106 [13NO]

Motions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2330), S11081 [25OC], H7549 [31OC]

Remarks in House

Abortions: approval of the abortion drug known as RU-486, E123 [6FE]

Agriculture: prohibit products containing dry ultra-filtered milk or casein from being labeled domestic natural cheese (H.R. 1016), H88 [14MR]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2330), H3624 [27JN], H3744-H3787 [28JN], H3829, H3830 [10JY], H3871, H3873, H3874-H3927, H3929, H3945 [11JY], H7549 [31OC], E1205 [26JN], E1321, E1325, E1328, E1329 [12JY], E1333 [16JY], E1345 [17JY]

———making appropriations (H.R. 2330), conference report, H8067-H8081 [13NO]

———making appropriations (H.R. 2330), consideration (H. Res. 183), H3738-H3744 [28JN]

———making appropriations (H.R. 2330), motion to instruct conferees, H7549-H7553 [31OC]

———making appropriations (H.R. 2330), permission to file conference report, H7918 [8NO]

———making appropriations (H.R. 2330), unanimous-consent request, H3784 [28JN]

Animals: increase the availability of drugs for minor species and rare diseases in all animals (H.R. 1956), E904 [23MY]

Buy American Act: compliance, H3907 [11JY]

Children and youth: labeling requirements to certify that child labor was not used in harvesting of cocoa beans, H3781-H3784 [28JN], H4594 [25JY]

Committee on Appropriations (House): appropriations allocation revisions to H.R. 2330, agriculture, rural development, FDA, and related agencies programs, H3790 [28JN]

Dept. of Agriculture: require a report on coordinated actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease (S. 700), H2051-H2053 [9MY]

Dept. of HHS: establish an Office on Women's Health (H.R. 1784), H2058 [9MY]

Diseases: safety of certain medications approved for use by diabetes patients, E2207 [5DE]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, H3598 [26JN], H3624 [27JN], H3756 [28JN], H3880-H3889 [11JY], E1345 [17JY]

———allow importation of prescription drugs into the U.S. by U.S. citizens for personal use, H3494 [25JN], H3789 [28JN], H3871, H3890-H3897 [11JY], E1345 [17JY]

———discrepancy in prescription drug prices between U.S. and foreign countries, H1837-H1841 [2MY], H3598 [26JN], H3624 [27JN], H3756 [28JN], H3851-H3858 [10JY]

———discrepancy in prescription drug prices between U.S. and foreign countries (H. Res. 26), E98 [1FE]

———prohibit funding to prevent importation into the U.S. of certain approved drugs, H3690 [27JN]

———require new drug applications include a statement specifying the total cost of research and development, H3921 [11JY]

Fish and fishing: delay approval of transgenic or genetically engineered fish, H3897-H3901 [11JY]

———provide clarification regarding the market name for the fish Pangasius bocourti and compliance with the Federal Food, Drug, and Cosmetic Act, H6267, H6268, H6269 [4OC]

Food: consumer access to information on the health benefits of foods and dietary supplements (H.R. 2265), E1175 [21JN]

———improve safety of imported foods, H8827 [4DE]

———safety programs for foodborne threats funding through reductions in Medicine Equity and Drug Safety Act funding, H3918 [11JY]

Food industry: require Dept. of Agriculture report on safety and monitoring of genetically engineered foods, H3765-H3767 [28JN], H6266 [4OC]

Food Safety Inspection Service: funding, H3741, H3758, H3770-H3772 [28JN]

Government regulations: establish labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors (H.R. 3066), E1833 [9OC]

Hazardous substances: recall and suspend use of vaccines containing mercury and certain other chemical substances, H2174-H2176 [15MY], H10206 [18DE]

Insurance: provide coverage for individuals participating in approved clinical trials, H3703 [27JN]

Office of Generic Drugs: funding, H3778, H3779 [28JN]

Pharmaceuticals: approval of generic versions of drugs without pediatric labeling relative to exclusive marketing rights agreements, H8551 [28NO], H10209 [18DE], E2286 [13DE]

———improve safety and efficacy for children (H.R. 2887), H7562 [31OC], H7727 [6NO], H8094-H8107 [13NO], H8166 [14NO], H8551 [28NO], E2073 [14NO], E2103 [15NO], E2114 [16NO], E2286 [13DE]

———improve safety and efficacy for children (S. 1789), H10200-H10212 [18DE], E2368, E2389 [20DE]

———reallocation of funding to the Office of Generic Drugs to evaluate and review potential patent abuses, H3919-H3921 [11JY]

Research: antimicrobial resistance monitoring and prevention programs funding, H3779-H3781 [28JN]

Safety: improve safety of imported foods (H.R. 3075), E1837 [10OC]

———pre-market device review funding, H8079 [13NO]

———require manufacturers of dietary supplements to register and require submission of reports on adverse experiences regarding such supplements (H.R. 3065), E1833 [9OC]

Seafood: ensure safety, H8078 [13NO]

St. Jude Medical Inc.: tribute on invention of sutureless bypass surgery device, E994 [26MY]

Taxation: treatment of direct-to-consumer advertisements of prescription drugs that fail to provide certain information to the consumer (H.R. 2352), E1225 [27JN]

TMJ Implants, Inc.: conduct investigation into FDA actions relative to the Pre-Market Application for the Fossa-Eminece Prosthesis, H3760 [28JN], E1321 [12JY]

———FDA premarket approval application review process of total and partial joint prostheses, E15 [3JA]

Tobacco products: grant authority to regulate tobacco (H.R. 1097), H914-H918 [14MR]

———grant authority to regulate tobacco (H.R. 2180), E1117 [14JN]

———tobacco industry liability settlement relative to health risks and marketing and manufacturing practices, H4002-H4006 [12JY]

Women: protect breastfeeding by new mothers, establish performance standard for breast pumps, and allow tax credit for enabling mothers to breastfeed or express milk at work (H.R. 285), E360 [14MR]

Remarks in Senate

Agriculture: prohibit products containing dry ultra-filtered milk or casein from being labeled domestic natural cheese (S. 117), S389 [22JA]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2330), S11060-S11095 [25OC], S11190, S11191, S11247 [30OC], S11337 [1NO]

———making appropriations (H.R. 2330), conference report, S11872-S11878 [15NO]

———making appropriations (H.R. 2330), conference report—unanimous-consent agreement, S11867 [14NO]

———making appropriations (H.R. 2330), unanimous-consent agreement, S10970, S10971 [24OC]

———making appropriations (S. 1191), indefinitely postponed, S12216 [29NO]

Animals: establish a Federal task force to coordinate actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease (S. 534), S2316 [14MR]

Bush, President: nomination of individuals to fill positions at certain public health agencies, S11255 [31OC]

Committee on Appropriations (Senate): tribute to staff for efforts relative to H.R. 2330, agriculture, rural development, FDA, and related agencies programs appropriations, S11095 [25OC]

Dept. of Agriculture: reduce appropriations for low-priority, unnecessary, and wasteful spending programs, S11073-S11075 [25OC], S11337 [1NO], S11876 [15NO]

———require a report on coordinated actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease (S. 700), S3452, S3459 [4AP], S3634 [5AP]

———require a report on coordinated actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease (S. 708), S3699, S3709-S3711 [6AP]

Dept. of HHS: establish an Office on Women's Health (S. 946), S5618-S5620 [24MY]

Dietary supplements: regulations enforcement funding, S11092-S11094 [25OC], S11272 [31OC]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, S7440 [11JY], S7871 [18JY], S11071 [25OC]

———discrepancy in prescription drug prices between U.S. and foreign countries, S7871 [18JY], S11071 [25OC]

———distribution chain of prescription drugs (S. 1132), S7104 [28JN]

———permit individuals to import prescription drugs in limited circumstances (S. 1229), S8131 [24JY]

Federal Food, Drug, and Cosmetic Act: amend relative to new animal drugs (S. 1346), S8768 [2AU]

Fish and fishing: repeal ban on importation of certain fish and fish products not taxonomically from the catfish family, S13110 [13DE], S13247 [14DE], S13426-S13441 [18DE]

———restrict importation of certain fish and fish products not taxonomically from the catfish family, S11091 [25OC], S11337, S11338 [1NO]

Food Safety Administration: establish as independent agency to consolidate food safety, labeling, and inspection functions (S. 1501), S10295 [4OC]

Health: allow access to drugs and medical devices recommended and provided by health care practitioners that are not approved by the FDA (S. 1378), S8951 [3AU]

Insurance: provide coverage for individuals participating in approved clinical trials, S6465, S6469, S6470, S6473, S6501 [20JN], S6583-S6594 [21JN], S6627-S6634 [22JN], S7129, S7130, S7169 [29JN]

New Mexico State University Physical Science Laboratory: food inspection systems funding, S11085, S11086 [25OC]

Pharmaceuticals: improve safety and efficacy for children (S. 838), S4422-S4425 [7MY], S10816-S10819, S10826-S10831 [18OC], S10871-S10873 [23OC]

———improve safety and efficacy for children (S. 1301), S8597-S8599 [1AU]

———improve safety and efficacy for children (S. 1789), S12752 [7DE], S12755 [10DE], S13070 [12DE]

———permit import of prescription medications sold in certain foreign countries and correct impediments in implementation of the Medicine Equity and Drug Safety Act (S. 215), S775 [30JA], S7440 [11JY]

———provide access and choice for use of generic drugs under Federal health care programs (S. 186), S572 [25JA], S8394 [30JY]

———response to shortage of betamethasone drugs relative to premature delivery of babies, S5528 [23MY]

Safety: ensure protection of the U.S. food supply, S13902, S13903 [20DE]

———food safety initiative activities funding, S3662 [6AP]

———improve safety of imported foods (S. 1634), S11443 [5NO], S11592-S11594 [8NO]

———timely evaluation of medical device technologies funding, S11190, S11191 [30OC]

Senior citizens: educational activities relative to generic drugs funding, S11191 [30OC]

Surgeon General: release of ``Women and Smoking'' report, S2972 [27MR]

Tobacco products: grant authority to regulate tobacco (S. 247), S1063 [6FE], S2972 [27MR]

Reports

Liver Failure Risk for Diabetes Patients Taking Rezulin: David J. Graham and Lanh Green, E2207-E2209 [5DE]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee of Conference (H.R. 2330) (H. Rept. 107-275), H8034 [9NO]

———Committee on Appropriations (House) (H.R. 2330) (H. Rept. 107-116), H3711 [27JN]

———Committee on Appropriations (Senate) (S. 1191) (S. Rept. 107-41), S7878 [18JY]

Best Pharmaceuticals for Children Act: Committee on Energy and Commerce (House) (H.R. 2887) (H. Rept. 107-277), H8034 [9NO]

———Committee on Health, Education, Labor, and Pensions (Senate) (S. 838) (S. Rept. 107-79), S10286 [4OC]

Consideration of H.R. 2330, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 183) (H. Rept. 107-118), H3711 [27JN]

Rulings of the Chair

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2330), H3772 [28JN], H3909, H3922 [11JY]

Summaries

National Youth Smoking Reduction Act (H.R. 2180), E1118 [14JN]

Tables

Agriculture, rural development, FDA, and related agencies programs appropriations (H.R. 2330), H3745-H3751 [28JN]

———conference report, H8069-H8075 [13NO]

Committee on the Budget (Senate) scoring of conference report on H.R. 2330, agriculture, rural development, FDA, and related agencies programs appropriations, S11875 [15NO]

Committee on the Budget (Senate) scoring of S. 1191, agriculture, rural development, FDA, and related agencies programs appropriations, S11087 [25OC]

Drug price comparison, H3495 [25JN]

Estimated cost to consumers of exclusivity extensions for certain pediatric drugs, H8102 [13NO]

Texts of

H. Res. 183, consideration of H.R. 2330, agriculture, rural development, FDA, and related agencies programs appropriations, H3738 [28JN]

H.R. 2330, agriculture, rural development, FDA, and related agencies programs appropriations, S11236-S11247 [30OC]

H.R. 2887, Best Pharmaceuticals for Children Act, H8094-H8098 [13NO]

S. 117, Quality Cheese Act, S390 [22JA]

S. 186, Generic Pharmaceutical Access and Choice for Consumers Act, S573 [25JA]

S. 215, Medication Equity and Drug Savings Act, S776 [30JA]

S. 247, Kids Deserve Freedom From Tobacco Act, S1063-S1066 [6FE]

S. 534, Mad Cow Prevention Act, S2316 [14MR]

S. 700, Animal Disease Risk Assessment, Prevention, and Control Act, H2051-H2053 [9MY]

S. 700, require a report on coordinated actions to prevent bovine spongiform encephalopathy (mad cow disease) and foot-and-mouth disease, S3453 [4AP], S3634-S3636 [5AP]

S. 838, Best Pharmaceuticals for Children Act, S4422-S4424 [7MY]

S. 1635, Pathogen Research, Emergency Preparedness and Response Efforts (PREPARE) Act, S11489-S11491 [6NO]

S. 1789, Best Pharmaceuticals for Children Act, S13071-S13076 [12DE], H10200-H10204 [18DE]