H.R. 3311 Page Two 8.2 percent ad valorem. Effect on Revenue Based upon estimates of 1982 imports, future loss of revenue as a result of enactment of this legislation would be about $112,800 in 1983, declining to about $65,000 in 1987 because of staged reductions in the rates of duty. Subcommittee Action Agency Reports The Department of Commerce has no objection to enactment of H.R. 3311. The International Trade Commission submitted an informative report. Markup On June 27, 1984, the Subcommittee on Trade ordered H.R. 3311 favorably reported to the full Committee on Ways and Means by voice vote, with technical amendments, including changes in the article description and in the effective date to make the new provision effective 15 days after date of enactment and to have the provision expire on a date certain. Senate Action A companion bill (S-2198) was introduced by Senator Wallop. Administration Department of Commerce: No objection to enactment of H.R. 3311. To suspend the duty for a three year period on 1-Piperidinebutanol, alpha-[4-(1,1-dimethylethyl)phenyl]-4-(hydroxy-diphenylmethyl), otherwise known as terfenadine. Summary of the Provision H.R. 3312, if enacted, would suspend the duty on terfenadine otherwise known as 1-Piperidinebutanol, alpha-[4-(1,1-dimethylethy) pheryl]-4-(hydroxy-diphenylmethyl) until the close of September 30, 1987. Section-by-Section Analysis Section 1 of H.R 3312, if enacted, would amend subpart B of part 1 of the Appendix to the Tariff Schedules of the United States (19 U.S.C. 1202) by inserting a new item 907.25 to suspend the column 1, MFN, duty on terfenadine, otherwise known as 1-Piperidine butanol, alpha-[4-(1,ldimethylethyl)phenyl]-4-(hydroxy-diphenyl-methyl), provided for in item 411.58, part 1C, schedule 4, until the close of September 30, 1987. There will be no change in the column 2 rate. Section 2 makes the provision effective on or after the 15th day after the date of the enactment of the Act. Background and Justification Currently, the Food and Drug Administration (FDA) lists terfenadine as an investigatory new drug not approved for use in the United States. The product, if approved, will be sold under the trademark Seldone. According to the prospective importer, terfenadine is marketed in Europe as an antihistamine. The exact medical conditions for which terfenadine will be used in the United States will not be known until after FDA approval is obtained. The product is already being marketed in Europe and Canada. Comparison With Present Law Terfenadine has been imported into the United States for clinical trials under TSUS item 411.58 as an antihistamine not provided for in the Chemical Appendix to the TSUS. The column 1, MFN, rate of duty is 9.2 percent ad valorem and has been in effect since July 1, 1980. The current column 1 rate H.R. 3312 reflects the full U.S. Multilateral Trade Negotiations (MTN) concession rate implemented with staging for articles classifiable under TSUS item 411.58. The pre-MTN rate was 1.7 cents per pound plus 12.5 percent ad valorem until June 30, 1980. The column 2 rate of duty is 7 cents per pound plus 82 percent ad valorem. Imports from designated beneficiary developing countries under TSUS item 411.58 are elibible for duty-free entry under the Generalized System of Preferences (GSP). The LDDC rate of duty is the same as the column 1 rate of duty. Effect on Revenue It is estimated that the future loss of customs revenue as a result of this legislation would be about $830,000 annually, based on projected annual imports of 18,000 pounds of terfenadine. Subcommittee Action Agency Reports The Department of Commerce has no objection to enactment of H.R. 3312. International Trade Commission submitted an informative report. Markup On June 27, 1984, the Subcommittee on Trade ordered H.R. 3312 favorably reported to the full Committee on Ways and Means by voice vote, with technical amendments, including changes in the article description and in the effective date to make the new provision effective 15 days after date of enactment and to have the provision expire on a date certain. Senate Action A companion bill (S. 2197) was introduced by Senator Wallop. Administration Department of Commerce: No objection to enactment of H.R. 3312. To suspend the duty for a three year period on 2-[4-(2-Chloro1,2-diphenylethenyl)-phenoxy]-N,N-diethylethanamine dihydrogen citrate, otherwise known as clomiphene citrate. Summary of the Provision H.R. 3313, if enacted, would suspend the duty on clomiphene citrate otherwise known as 2-[4-(2-Chloro-1,2-diphenylethenyl) – phenoxy-]-N,N-diethylethanamine dihydrogen citrate until the close of September 30, 1987. Section-by-Section Analysis Section 1 of H.R 3313, if enacted, would amend subpart B of part 1 of the Appendix to the Tariff Schedules of the United States (19 U.S.C. 1202) by inserting a new item 907.29 to suspend the column 1, MFN, duty on clomiphene citrate otherwise known as 2-[4– (2-Chloro-1,2-dephenylethenyl) phenoxy]N,N-diethylethanamine dihydrogen citrate, provided for in item 412.50, part 1C, schedule 4, until the close of September 30, 1987. There will be no change in the column 2 rate. Section 2 makes the provision effective on or after the 15th day after the date of the enactment of this Act. Background and Justification Clomiphene citrate occurs as a white-to-pale yellow, crystalline powder and is sparingly soluble in water and in alcohol. Clomiphene citrate has both estrogenic and antiestrogenic properties. The drug is used to induce ovulation in anovulary women. In addition, clomiphene citrate is used in small doses as an agent in therapy for male infertility. This chemical is used in the manufacture of the ethical pharmaceutical product (prescription drug) sold under the trademark Clomid. According to industry sources, clomiphene citrate is not produced in the United States. The product is manufactured by Societe Chimique Grevis S.A., a wholly-owned subsidiary of Merrell Dow, and is located in France. It is also sold in the U.S. by Serano under the trademark Seraphene. Comparison With Present Law Clomiphene citrate is classified under TSUS item 412.50 as a hormone, synthetic substitute, or antagonist not provided for in the Chemical Appendix to the TSUs. H.R. 3313 The column 1 rate of duty is 8.7 percent ad valorem and has been in effect since July 1, 1980. The current column 1 rate reflects the full U.S. Multilateral Trade Negotiations (MTN) concession rate implemented without staging for articles classifiable under TSUS item 411.50. The pre-MTN rate was 1.7 cents per pound plus 12.5 percent ad valorem until June 30, 1980. The column 2 rate of duty is 7 cents per pound plus 78.5 percent ad valorem. Imports from designated beneficiary developing countries under TSUS item 411.50 are not eligible for duty-free entry under the Generalized System of Preferences (GSP). The LDDC rate of duty is the same as the column 1 rate of duty. Effect on Revenue It is estimated that the future loss of customs revenue as a result of this legislation would be $78,000 annually. Subcommittee Action Agency Reports The Department of Commerce has no objection to enactment of H.R. 3313. International Trade Commission submitted an informative report. Markup On June 27, 1984, the Subcommittee on Trade ordered H.R. 3313 favorably reported to the full Committee on Ways and Means by voice vote, with technical amendments, including changes in the article description and in the effective date to make the new provision effective 15 days after date of enactment and to have the provision expire on a date certain. Senate Action A companion bill (S. 2172) was introduced by Senator Wallop. Administration Department of Commerce: No objection to enactment of H. R. 3313. |