FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4800), H5250 [10JN], H5287, H5288, H5289, H5290, H5291, H5292, H5294, H5296, H5297, H5298, H5299, H5300, H5304, H5305, H5320 [11JN]

——— making appropriations (H.R. 4800), consideration (H. Res. 616), H5263 [11JN]

Bills and resolutions

Agriculture: authorize the interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow the sale of such products (see H.R. 4307), H2695 [26MR]

——— prohibit Federal interference in interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow the sale of such products (see H.R. 4308), H2695 [26MR]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 2389), S3293 [22MY] (see H.R. 4800), H5072 [5JN]

——— making appropriations (H.R. 4800), consideration (see H. Res. 616), H5248 [10JN]

Business and industry: extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (see H.R. 5750), H8169 [20NO]

Consumers: allow for regulation of electronic nicotine delivery systems and e-liquids like tobacco cigarettes and establish labeling, packaging, and dosage limits for such products (see H.R. 5010), H5818 [26JN]

Contraceptives: ensure employers cannot prohibit access, call for an FDA study on whether prescriptions are necessary for contraceptives, and allow use of certain health accounts to purchase over-the-counter drugs (see S. 2605), S4502 [15JY]

——— establish certain duties for pharmacies to ensure provision of FDA-approved contraception (see S. 2625), S4620 [17JY]

Dept. of HHS: require NIH to consider sex differences in medical research and direct FDA to guarantee clinical drug trials are sufficient to determine safety and effectiveness for both men and women (see H.R. 4879), H5398 [17JN]

Dept. of Veterans Affairs: adopt and implement a standard identification protocol for use in tracking and procurement of biological implants and tissue or bone grafts (see H.R. 4374), H2853 [2AP]

Diseases: expand priority review voucher incentive program to encourage treatments for tropical diseases (see H.R. 5729), H8071 [18NO]

——— facilitate effective research on, and treatment of, neglected tropical diseases through coordinated domestic and international efforts (see H.R. 4847), H5318 [11JN]

——— incentivize the development of treatments and vaccines for ebola by adding the disease to priority review voucher program (see S. 2917), S5918 [12NO]

Drugs: encourage development and use of new antimicrobial drugs in order to treat antibiotic-resistant infections (see H.R. 4187), H2300 [11MR]

——— ensure eligible product developers have competitive access to approved drugs and licensed biological products to enable development and testing of new products (see H.R. 5657), H7886 [18SE]

——— establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (see H.R. 5874), H9303 [11DE]

——— improve DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and registration process for use of controlled substances in clinical trials (see S. 2862), S5782 [18SE] (see H.R. 4299), H2694 [26MR]

——— reform program allowing for expanded access to certain experimental treatments or breakthrough drugs for seriously ill patients (see H.R. 5805), H8867 [8DE]

——— withdraw approval for the drug Zohydro ER and prohibit from approving such drug unless it is reformulated to prevent abuse (see S. 2134), S1652 [13MR] (see H.R. 4241), H2433 [13MR]

Economy: extend unemployment benefits, approve Keystone XL Pipeline, repeal medical device tax, restore 40-hour work week, and provide reemployment assessments (see H.R. 3885), H472 [15JA]

Food: establish Federal labeling standards for food with genetically modified ingredients and natural foods (see H.R. 4432), H3142 [9AP]

FTC: prohibit the marketing of electronic cigarettes to children (see S. 2047), S1174 [26FE] (see H.R. 4325), H2743 [27MR]

Government regulations: ensure that certain facilities continue to be treated as alcohol-related facilities, notwithstanding the distribution of spent grains resulting from the production of alcoholic beverages (see H.R. 4430), H3057 [8AP]

——— provide for the regulation of patient records and certain decision support medical software (see S. 2977), S6350 [4DE]

Health: provide regulatory clarity over clinical and health software and relieve categories of such low-risk software from the medical device tax (see S. 2007), S852 [10FE]

NIH: research risks posed by dioxin, synthetic fibers, and other additives in feminine hygiene products and urge the FDA to monitor and disclose contaminants in all menstrual hygiene products (see H.R. 4746), H4909 [28MY]

Patents: advance public health by encouraging independent innovators to pursue drug repurposing research and develop new treatments and cures by providing intellectual property protections for those innovations (see S. 2150), S1691 [24MR] (see H.R. 4287), H2610 [24MR]

Pharmaceuticals: allow importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (see H.R. 5854), H9302 [11DE]

——— allow personal importation of safe and affordable drugs from approved pharmacies in Canada (see S. 2549), S4153 [26JN]

——— expedite review of pharmaceuticals approved for marketing in the European Union (see H.R. 4918), H5557 [19JN]

Research: create a limited population pathway for approval of certain antibacterial drugs (see S. 2996), S6540 [10DE]

Safety: ensure that liquid over-the-counter medications are packaged with appropriate dosage delivery devices and, in the case of such medications labeled for pediatric use, appropriate flow restrictors (see H.R. 5613), H7885 [18SE]

——— provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (see S. 2141), S1652 [13MR]

Science: recognize importance of breakthroughs in biomedicine, biotechnology, and life sciences in diagnosis and treatment of illness and address funding gap between basic research and clinical development (see H. Res. 709), H7185 [31JY]

Sunscreen: provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (see H.R. 4250), H2433 [13MR]

Water: explore emerging technologies that are mobile and capable of supplying high volumes of sterile, pathogenic-free water (see H. Res. 549), H3057 [8AP]

——— require bottled water manufacturers and distributors to disclose bottled water quality information (see H.R. 4978), H5816 [26JN]

Letters

Sunscreen Innovation Act: Brett M. Coldiron, American Academy of Dermatology Association, H6931 [28JY]

——— Christopher W. Hansen, American Cancer Society, H6931 [28JY]

——— Mary Antonucci, Melanoma Research Foundation, H6932 [28JY]

——— Steven Goldberg, BASF Corp., H6931 [28JY]

——— Wendy K.D. Selig, Melanoma Research Alliance, H6932 [28JY]

Remarks in House

Agriculture, rural development, FDA, and related agencies programs: making appropriations, H441 [15JA]

——— making appropriations (H.R. 4800), H5265–H5312 [11JN], H6299 [16JY], E966, E967, E970 [12JN]

——— making appropriations (H.R. 4800), consideration (H. Res. 616), H5259–H5265 [11JN]

Budget: prohibit cuts in budget baseline for education, health, and safety protections, H3020 [8AP]

Business and industry: extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (H.R. 5750), H8938 [10DE]

Dept. of HHS: foster further innovation and entrepreneurship in the health information technology sector (H.R. 2363), E1447 [17SE]

Diseases: facilitate effective research on, and treatment of, neglected tropical diseases through coordinated domestic and international efforts (H.R. 4847), E1346 [8SE]

——— improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases, E1321 [1AU]

——— incentivize the development of treatments and vaccines for ebola by adding the disease to priority review voucher program (S. 2917), H8344 [3DE]

Food: exempt food safety, including infant formula, regulations from OMB Office of Information and Regulatory Affairs requirement to publish proposed Federal regulations on a monthly basis, H1974 [26FE]

Food industry: improve and clarify certain disclosure requirements for restaurants, similar retail food establishments, and vending machines (H.R. 1249), E966 [12JN]

Funding, H5260 [11JN]

Government regulations: proposed regulations relative to laboratory developed tests, H7248 [8SE]

Hardy, Josh: tribute to support of family and friends relative to appeal to FDA for expedited approval of experimental drug treatment, H2369 [13MR]

National Gay Blood Drive: tribute, H6039 [10JY]

NIH: research risks posed by dioxin, synthetic fibers, and other additives in feminine hygiene products and urge the FDA to monitor and disclose contaminants in all menstrual hygiene products (H.R. 4746), E847 [28MY]

Pharmaceuticals: expedite approval of certain pharmaceuticals and experimental treatments used in cancer treatments, E1424 [16SE]

Safety: provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (S. 2141), H7959 [13NO]

Sunscreen: provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (H.R. 4250), H6928–H6933 [28JY], E1304 [1AU]

Taxation: repeal excise tax on medical devices, H7813, H7815 [18SE]

Remarks in Senate

Agriculture, rural development, FDA, and related agencies programs: making appropriations, S395–S397 [16JA], S3776–S3784, S3788, S3792, S3798–S3800, S3804 [18JN], S3852 [19JN], S3887 [23JN]

China: investigate safety of pet food, pet treats, processed chicken, and animal feed imported from China, S3803 [18JN]

Contraceptives: ensure employers cannot prohibit access, call for an FDA study on whether prescriptions are necessary for contraceptives, and allow use of certain health accounts to purchase over-the-counter drugs (S. 2605), S4475 [15JY], S4514, S4522 [16JY]

——— establish certain duties for pharmacies to ensure provision of FDA-approved contraception (S. 2625), S4622 [17JY]

Crime: decriminalization of marijuana, S1274 [4MR]

Dept. of Agriculture: coordinate efforts with FDA to secure work visas for U.S. food safety inspectors to investigate Chinese processing facilities that produce pet food and chicken for human consumption, S3804 [18JN]

Diseases: incentivize the development of treatments and vaccines for ebola by adding the disease to priority review voucher program (S. 2917), S6271 [2DE]

Economy: extend unemployment benefits, approve Keystone XL Pipeline, and restore 40-hour work week, S1907 [1AP]

Family Smoking Prevention and Tobacco Control Act: anniversary, S4139 [26JN]

Funding, S3784 [18JN]

Hardy, Josh: tribute to support of family and friends relative to appeal to FDA for expedited approval of experimental drug treatment, S1646 [13MR]

Health: provide regulatory clarity over clinical and health software and relieve categories of such low-risk software from the medical device tax, S1557 [12MR]

——— provide regulatory clarity over clinical and health software and relieve categories of such low-risk software from the medical device tax (S. 2007), S853, S854 [10FE]

Obama, President: evaluation of administration, S509–S512 [28JA]

Safety: provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients (S. 2141), S1725 [25MR], S5715–S5720 [17SE]

Taxation: repeal excise tax on medical devices, S505 [28JA], S871 [11FE], S1149 [26FE], S2056 [2AP], S2139 [3AP], S2927 [13MY], S3052, S3054 [15MY], S3996 [25JN], S4873 [24JY], S6435 [9DE]

——— repeal excise tax on medical devices (S. 232), S48 [7JA], S2431 [29AP], S2933 [13MY]

Tobacco products: expand authority to regulate tobacco products, including e-cigarettes and flavored cigars, S342, S359 [15JA]

——— provide with certain regulatory authority over tobacco products aimed at attracting minors, S4139 [26JN]

Reports filed

Adding Ebola to the FDA Priority Review Voucher Program Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2917), S6148 [19NO]

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 4800) (H. Rept. 113–468), H5072 [5JN]

——— Committee on Appropriations (Senate) (S. 2389) (S. Rept. 113–164), S3293 [22MY]

Consideration of H.R. 4800, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 616) (H. Rept. 113–472), H5248 [10JN]

Improving Regulatory Transparency for New Medical Therapies Act: Committee on Energy and Commerce (House) (H.R. 4299) (H. Rept. 113–565), H7038 [29JY]

——— Committee on the Judiciary (House) (H.R. 4299) (H. Rept. 113–565), H7900 [19SE]

Sunscreen Innovation Act: Committee on Energy and Commerce (House) (H.R. 4250) (H. Rept. 113–558), H6813 [24JY]

——— Committee on Health, Education, Labor, and Pensions (Senate) (S. 2141), S5697 [17SE]

Tables

Agriculture, rural development, FDA, and related agencies programs appropriations (H.R. 4800), H5268–H5280 [11JN]

Texts of

H. Res. 616, consideration of H.R. 4800, agriculture, rural development, FDA, and related agencies programs appropriations, H5259 [11JN]

H.R. 4250, Sunscreen Innovation Act, H6928–H6930 [28JY]

S. 2141, Sunscreen Innovation Act, S5715–S5720 [17SE], H7959–H7964 [13NO]

S. 2917, Adding Ebola to the FDA Priority Review Voucher Program Act, S6271 [2DE], H8344 [3DE]