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Page:United States Statutes at Large Volume 98 Part 2.djvu/417

 PUBLIC LAW 98-412—AUG. 30, 1984

98 STAT. 1577

and export policies, programs, and practices of the United States, including, but not limited to, the following: "(A) producers of major agricultural commodities in the United States; "(B) processors or refiners of United States agricultural commodities; "(C) exporters, transporters, or shippers of United States agricultural commodities and products to foreign countries; "(D) suppliers of production equipment or materials to United States farmers; "(E) providers of financing or credit for domestic and export agricultural purposes; and "(F) organizations representing general farm and rural interests in the United States. "(c) The chairmen and ranking minority members of the House Committee on Agriculture, the Senate Committee on Agriculture, Nutrition, and Forestry, the House Committee on Foreign Affairs, the Senate Committee on Foreign Relations, the House Committee on Ways and Means, and the Senate Committee on Finance shall serve as ex officio members of the Commission and shall have the same voting rights as the members of the Commission selected and appointed under the provisions of subsection (b)(2) of this section. The chairmen and ranking minority members may desigpnate other members of their respective committees to serve in their stead as members of the Commission. "(d) A vacancy in the Commission shall be filled in the manner in which the original appointment was made. "(e) The Commission shall elect a chairman from among the members of the Commission who are selected and appointed under the provisions of subsection (b)(2) of this section. "(f) The Commission shall meet at the call of the chairman or a majority of the Commission.

'

"CONDUCT OP STUDY

"SEC. 1220. The Commission shall study the agriculture-related 7 USC 1691 note. trade and export policies, programs, and practices of the United States and the international and domestic factors affecting such policies, programs, and practices, including the intergovernmental activities of the United States that affect the formulation of policies. In conducting the study, the Commission shall consider, among other things, the following: "(1) the effectiveness of existing agricultural export assistance programs, and the manner in which they can be improved; "(2) new export assistance programs that should be considered, and the conditions under which they can be implemented; "(3) practices of foreign countries that impede the export of United States agricultural commodities and products, and appropriate responses for the United States; "(4) the effectiveness of the trade agreements program of the United States with respect to agriculture-related trade and exports, and the manner in which it can be improved; "(5) international economic trends that affect agricultural exports, and the manner in which the United States can best adjust its policies, programs, and practices to meet changing economic conditions;

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Page:United States Statutes at Large Volume 98 Part 2.djvu/418

 98 STAT. 1578

PUBLIC LAW 98-412—AUG. 30, 1984 "(6) potential areas of conflict and compatibility between international agricultural trade and foreign food assistance programs, and the manner in which any conflict can be resolved; and "(7) the relationship between international agricultural trade and foreign economic development and food programs, and the manner in which they can be made more compatible. "RECOMMENDATIONS AND REPORTS

7 USC 1691 note.

"SEC. 1221. (a) On the basis of its study, the Commission shall make findings and develop recommendations for consideration by the President and Congress with respect to the agriculture-related trade and export policies, programs, and practices of the United States, and the manner in which such policies, programs, and practices can be improved to better develop, maintain, and expand markets for United States agricultural exports. "(b) The Commission shall submit to the President and Congress— "(1) a report containing its initial findings and recommendations by March 31, 1985, "(2) such additional interim reports on its work as may be requested by the chairman of any of the Committees set forth in section 1219(c) of this subtitle, and "(3) a report containing the final results of its study and its recommendations therefrom by July 1, 1986. "ADMINISTRATION

7 USC 1691 note.

5 USC 5101 et seq., 5331.

"SEC. 1222. (a) The heads of Executive agencies, the General Accounting Office, the International Trade Commission, and the Congressional Budget Office shall, to the extent permitted by law, provide the Commission such information as it may require in carrying out its duties and functions. "(b) Members of the Commission shall serve without any additional compensation for work on the Commission. However, members appointed from among private citizens of the United States may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by law for persons serving intermittently in the government service under sections 5701 through 5707 of title 5, United States Code. "(c) To the extent there are sufficient funds available to the Commission in advance under section 1223 of this subtitle, and subject to such rules as may be adopted by the Commission, the chairman, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, shall have the power to— "(1) appoint and fix the compensation of a director; and "(2) appoint and fix the compensation of such additional staff personnel as the Commission determines necessary to carry out its duties and functions. "(d) Upon request of the Commission, the Secretary of Agriculture shall furnish the Commission with such personnel and support services as are necessary to assist the Commission in carrying out its duties and functions.

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license: Creative Commons - Attribution Share-Alike - https://creativecommons.org/licenses/by-sa/4.0/


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Page:United States Statutes at Large Volume 98 Part 2.djvu/419

 PUBLIC LAW 98-412—AUG. 30, 1984

98 STAT. 1579

"(e) Upon request of the Commission, the heads of other Executive agencies and the General Accounting Office are each authorized to furnish the Commission with such personnel and support services as the head of the agency or office and the chairman of the Commission agree are necessary to assist the Commission in carrying out its duties and functions. "(f) The Commission shall not be required to pay or reimburse any agency or office for personnel and support services provided under this section. "(g) In accordance with section 12 of the Federal Advisory Com- 5 USC app. mittee Act, the Secretary of Agriculture shall maintain such financial records as will fully disclose the disposition of any funds that may be at the disposal of the Commission and the nature and extent of its activities, and the Comptroller General of the United States, or any of the Comptroller General's authorized representatives, shall have access to such records for the purpose of audit and examination. "(h) The Commission shall be exempt from section 7(d), section 5 USC app. 10(e), section 10(f), and section 14 of the Federal Advisory Committee Act. "(i) The Commission shall be exempt from the requirements of sections 4301 through 4305 of title 5, United States Code. "PUBLIC SUPPORT

"SEC. 1223. (a) Following the appointment or designation of the 7 USC 1691 note. members of the Commission, notwithstanding the provisions of section 1342 of title 31, United States Code, the Secretary of Agriculture may receive, from persons, corporations, foundations, and all other groups and entities within the United States, contributions of money and services to assist the Commission in carrsdng out its duties and functions. Any money contributed under this section shall be available to the Commission for the payment of salaries, travel expenses, per diem, and other expenses incurred by the Commission under this subtitle. In no event may the contributions from any one person, corporation, foundation, or other group or entity exceed 5 per centum of the Commission's total budget. "(b) If the contributions provided under subsection (a) are insufficient for payment of Commission salaries, travel expenses, per diem, and other expenses incurred by the Commission under this subtitle, the Secretary of Agriculture is authorized to use the funds of the Commodity Credit Corporation for such purposes in an amount not to exceed a total of $1,000,000.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/420

 98 STAT. 1580 Public availability.

PUBLIC LAW 98-412—AUG. 30, 1984

"(c) The Secretary of Agriculture shall keep, and shall make available for public inspection during normal business hours, records that fully disclose a complete list of every person, group, and entity making a contribution under this section, the address of the contributor, the amount and type of each such contribution, and the date the contribution was made. "(d) Any amount of money available to the Commission under this section that remains unobligated upon termination of the Commission shall be deposited in the Treasury as miscellaneous receipts. "TERMINATION

7 USC 1691 note.

"SEC. 1224. The Commission shall terminate sixty days after the transmission of its final report to the President and Congress.". Approved August 30, 1984.

LEGISLATIVE HISTORY—H.J. Res. 600 (H. Con. Res. 349): HOUSE REPORT No. 98-956, Pt. 1 (Comm. on Agriculture). CONGRESSIONAL RECORD, Vol. 130 (1984): Aug. 6, considered and passed House. Aug. 10, considered and passed Senate. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 20, No. 35 (1984): Aug. 30, Presidential statement.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/421

 PUBLIC LAW 98-413-SEPT. 21, 1984

98 STAT. 1581

Public Law 98-413 98th Congress Joint Resolution Designating the week beginning September 23, 1984, as "National Adult Day Care Center Week".

Sept. 21, 1984 [H.J. Res. 505]

Whereas there are nearly eight hundred adult day care centers nationwide providing a safe and positive environment to partially disabled adults and senior citizens in need of daytime assistance and supervision; Whereas adult day care centers provide necessary health maintenance functions and medical care, including medication monitoring, therapies, and health education, and are operated by professional staffs who identify the need for additional health services and make appropriate referrals; Whereas adult day care centers provide opportunities for social interaction to otherwise isolated individuals and assist them in attaining and maintaining a maximum level of independence; and Whereas these centers offer relief to families who otherwise must care for disabled elderly persons on a twenty-four-hour-per-day basis: Now, therefore, be it Resolved by the Senate and House of Representatives of the United States of America in Congress assembled. That the week beginning September 23, 1984, is designated "National Adult Day Care Center Week". The President is authorized and requested to issue a proclamation calling upon the people of the United States to observe that week with appropriate ceremonies and activities. Approved September 21, 1984.

LEGISLATIVE HISTORY—H.J. Res. 505: CONGRESSIONAL RECORD, Vol. 130 (1984): Aug. 8, considered and passed House. Sept. 17, considered and passed Senate.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/422

 98 STAT. 1582

PUBLIC LAW 98-414—SEPT. 24, 1984

Public Law 98-414 98th Congress Joint Resolution Sept 24 1984 [H.J. Res. 545]

Designating the week of September 16 through 22, 1984 as "Emergency Medicine Week".

Whereas emergency medical personnel throughout our Nation are specialists trained to handle life- or limb-threatening illnesses and injuries requiring immediate attention, and must be available 24 hours every day of the week to all patients who need medical aid; Whereas the emergency medical services system in the United States provides emergency health care to millions of citizens annually; Whereas vast improvements in emergency medicine have been made in the past fifteen years, and emergency department personnel have completed extensive training and continuing education to keep up with these improvements; Whereas the efforts of these trained men and women have saved thousands of lives; and Whereas the observance of "Emergency Medicine Week" will educate our citizens about emergency medicine: Now, therefore, be it Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That the week of September 16 through 22, 1984 is designated "Emergency Medicine Week". The President is requested to issue a proclamation calling upon the people of the United States to observe that week with appropriate ceremonies and activities. Approved September 24, 1984.

LEGISLATIVE HISTORY—H.J. Res. 545: CONGRESSIONAL RECORD, Vol. 130 (1984): Sept. 12, considered and passed House. Sept. 20, considered and passed Senate.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/423

 PUBLIC LAW 98-415—SEPT. 24, 1984

98 STAT. 1583

Public Law 98-415 98th Congress Joint Resolution To designate September 21, 1984, as "World War I Aces and Aviators Day".

Whereas World War I, the "war to end all wars" began seventy years ago; Whereas that war spawned a new breed of warrior, the aviator, who engaged in single combat high above the conflict on the ground; Whereas these truly remarkable men defended the skies of Europe with valor and distinction; Whereas some of these aviators achieved the title "Ace" by gaining at least five confirmed victories over opponents in the air; Whereas there are only about sixty known surviving Aces of World War I, who meet periodically to share memories of a conflict familiar to many Americans only through recorded history; Whereas all Americans should express their gratitude and respect for these gallant air warriors for their extraordinary feats in defense of liberty: Now, therefore, be it Resolved by the Senate and House of Representatives of the United States of America in Congress assembled. That September 21, 1984, is designated as "World War I Aces and Aviators Day" and the President is authorized and requested to issue a proclamation calling upon the people of the United States to observe such day with appropriate progrguns and activities. Approved September 24, 1984.

LEGISLATIVE HISTORY—S.J. Res. 333: CONGRESSIONAL RECORD, Vol. 130 (1984): Aug. 10, considered and passed Senate. Sept. 20, considered and passed House.

Sept. 24, 1984 [S.J. Res. 333]

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Page:United States Statutes at Large Volume 98 Part 2.djvu/424

 98 STAT. 1584

PUBLIC LAW 98-416—SEPT. 24, 1984

Public Law 98-416 98th Congress Joint Resolution Sept. 24, 1984 [S.J. Res. 340]

To designate the week of September 23, 1984 as "National Historically Black Colleges Week".

Whereas there are one hundred and three historically black colleges and universities in the United States; Whereas they are providing the quality education so essential to full participation in our complex, highly technological society; Whereas black colleges and universities have a rich heritage and have played a prominent role in American history; Whereas these institutions have allowed many underprivileged students to attain their full potential through higher education; and Whereas the achievements and goals of these historically black colleges are deserving of national recognition: Now, therefore, be it Resolved by the Senate and House of Representatives of the United States of America in Congress assembled. That the week of September 23, 1984, is designated as "National Historically Black Ck>lleges Week" and the President of the United States is authorized and requested to issue a proclamation calling upon the people of the United States and interested groups to observe that week by engaging in appropriate ceremonies, activities, and programs, thereby showing their support of historically black colleges and universities in the United States. Approved September 24, 1984.

LEGISLATIVE HISTORY—S.J. Res. 340: CONGRESSIONAL RECORD, Vol. 130 (1984): Aug. 10, considered and passed Senate. Sept. 20, considered and passed House.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/425

 PUBLIC LAW 98-417—SEPT. 24, 1984 Public Law 98-417 98th Congress

98 STAT. 1585

An Act

To amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug appHcations, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Drug Price Competition and Patent Term Restoration Act of 1984". TITLE I—ABBREVIATED NEW DRUG APPLICATIONS SEC. 101. Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by redesignating subsection (j) as subsection (k) and inserting after subsection (i) the following: "(j)(1) Any person may file with the Secretary an abbreviated application for the approval of a new drug. "(2)(A) An abbreviated application for a new drug shall contain— "(i) information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed under paragraph (6) (hereinafter in this subsection referred to as a 'listed drug'); "(ii)(I) if the listed drug referred to in clause (i) has only one active ingredient, information to show that the active ingredient of the new drug is the same as that of the listed drug; "(II) if the listed drug referred to in clause (i) has more than one active ingredient, information to show that the active ingredients of the new drug are the same as those of the listed drug, or "(III) if the listed drug referred to in clause (i) has more than one active ingredient and if one of the active ingredients of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the other active ingredients of the new drug are the same as the active ingredients of the listed drug, information to show that the different active ingredient is an active ingredient of a listed drug or of a drug which does not meet the requirements of section 201(p), and such other information respecting the different active ingredient with respect to which the petition was filed as the Secretary may require; "(iii) information to show that the route of administration, the dosage form, and the strength of the new drug are the same as those of the listed drug referred to in clause (i) or, if the route of administration, the dosage form, or the strength of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require;

Sept. 24, 1984 [S. 1538]

Drug Price Competition and Patent Term Restoration Act of 1984. 21 USC 301 note.

Labeling.

21 USC 321.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/426

 98 STAT. 1586

Claims.

Prohibition.

Claims.

Marketing.

PUBLIC LAW 98-417—SEPT. 24, 1984

"(iv) information to show that the new drug is bioequivalent to the listed drug referred to in clause (i), except that if the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in clause (i) and the new drug can be expected to have the same therapeutic effect as the listed drug when administered to patients for a condition of use referred to in clause (i); "(v) information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug referred to in clause (i) except for changes required because of differences approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers; "(vi) the items specified in clauses (B) through (F) of subsection (b)(1); "(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c)— "(I) that such patent information has not been filed, "(11) that such patent has expired, "(III) of the date on which such patent will expire, or "(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and "(viii) if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. The Secretary may not require that an abbreviated application contain information in addition to that required by clauses (i) through (viii). "(B)(i) An applicant who makes a certification described in subparagraph (A)(viiXIV) shall include in the application a statement that the applicant will give the notice required by clause (ii) to— "(I) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and "(II) the holder of the approved application under subsection (b) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice, "(ii) The notice referred to in clause (i) shall state that an application, which contains data from bioavailability or bioequivalence studies, has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/427

 PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1587

"(iii) If an application is amended to include a certification described in subparagraph (A)(vii)(IV), the notice required by clause (ii) shall be given when the amended application is submitted. "(C) If a person wants to submit an abbreviated application for a new drug which has a different active ingredient or whose route of administration, dosage form, or strength differ from that of a listed drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve or disapprove a petition submitted under this subparagraph within ninety days of the date the petition is submitted. The Secretary shall approve such a petition unless the Secretary finds— "(i) that investigations must be conducted to show the safety and effectiveness of the drug or of any of its active ingredients, the route of administration, the dosage form, or strength which differ from the listed drug; or "(ii) that any drug with a different active ingredient may not be adequately evaluated for approval as safe and effective on the bsisis of the information required to be submitted in an abbreviated application. "(3) Subject to paragraph (4), the Secretary shall approve an application for a drug unless the Secretary finds— "(A) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity; "(B) information submitted with the application is insufficient to show that each of the proposed conditions of use have been previously approved for the listed drug referred to in the application; "(C)(i) if the listed drug has only one active ingredient, information submitted with the application is insufficient to show that the active ingredient is the same as that of the listed drug; "(ii) if the listed drug has more than one active ingredient, information submitted with the application is insufficient to show that the active ingredients are the same as the active ingredients of the listed drug, or "(iii) if the listed drug has more than one active ingredient and if the application is for a drug which has an active ingredient different from the listed drug, information submitted with the application is insufficient to show— "(I) that the other active ingredients are the same as the active ingredients of the listed drug, or "(II) that the different active ingredient is an active ingredient of a listed drug or a drug which does not meet the requirements of section 201(p), or no petition to file an application for the drug with the different ingredient was approved under paragraph (2)(C); "(D)(i) if the application is for a drug whose route of administration, dosage form, or strength of the drug is the same as the route of administration, dosage form, or strength of the listed drug referred to in the application, information submitted in the application is insufficient to show that the route of administration, dosage form, or strength is the same as that of the listed drug, or "(ii) if the application is for a drug whose route of administration, dosage form, or strength of the drug is different from that of the listed drug referred to in the application, no petition to

21 USC 321.

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text:
Author:William Oscar Scroggs

Works

 * Early Trade and Travel in the Lower Mississippi Valley (1911)
 * Filibusters and Financiers

title: Author:William Oscar Scroggs


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Page:United States Statutes at Large Volume 98 Part 2.djvu/428

 98 STAT. 1588

Labeling.

Effective dates.

PUBLIC LAW 98-417—SEPT. 24, 1984

file an application for the drug with the different route of administration, dosage form, or strength was approved under paragraph (2)(C); "(E) if the application was filed pursuant to the approval of a petition under paragraph (2)(C), the application did not contain the information required by the Secretary respecting the active ingredient, route of administration, dosage form, or strength which is not the same; "(F) information submitted in the application is insufficient to show that the drug is bioequivalent to the listed drug referred to in the application or, if the application was filed pursuant to a petition approved under paragraph (2)(C), information submitted in the application is insufficient to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in paragraph (2)(A)(i) and that the new drug can be expected to have the same therapeutic effect as the listed drug when administered to patients for a condition of use referred to in such paragraph; "(G) information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the listed drug referred to in the application except for changes required because of differences approved under a petition filed under paragraph (2)(C) or because the drug and the listed drug are produced or distributed by different manufacturers; "(H) information submitted in the application or any other information available to the Secretary shows that (i) the inactive ingredients of the drug are unsafe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug, or (ii) the composition of the drug is unsafe under such conditions because of the type or quantity of inactive ingredients included or the manner in which the inactive ingredients are included; "(I) the approval under subsection (c) of the listed drug referred to in the application under this subsection has been withdrawn or suspended for grounds described in the first sentence of subsection (e), the Secretary has published a notice of opportunity for hearing to withdraw approval of the listed drug under subsection (c) for grounds described in the first sentence of subsection (e), the approval under this subsection of the listed drug referred to in the application under this subsection has been withdrawn or suspended under paragraph (5), or the Secretary has determined that the listed drug has been withdrawn from sale for safety or effectiveness reasons; "(J) the application does not meet any other requirement of paragraph (2)(A); or "(K) the application contains an untrue statement of material fact. "(4)(A) Within one hundred and eighty days of the initial receipt of an application under paragraph (2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application. "(B) The approval of an application submitted under paragraph (2) shall be made effective on the last applicable date determined under the following:

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Page:United States Statutes at Large Volume 98 Part 2.djvu/429

 PUBLIC LAW 98-417—SEPT. "2l, 1984

98 STAT. 1589

"(i) If the applicant only made a certification described in subclause (I) or (II) of paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective immediately, "(ii) If the applicant made a certification described in subclause (III) of paragraph (2)(A)(vii), the approval may be made effective on the date certified under subclause (III). "(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that— "(I) if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision, "(II) if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, United States Code, or "(III) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision. In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under section 2201 of title 28, United States Code, for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business. "(iv) If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after— "(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or "(II) the date of a decision of a court in an action described in clause (iii) holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier. "(C) If the Secretary decides to disapprove an application, the Secretary shall give the applicant notice of an opportunity for a

Claims.

Post, p. 1603.

Post, p. 1597.

Hearing opportunity.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/430

 98 STAT. 1590

Prohibitions.

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984

hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs. "(D)(i) If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this subsection, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted effective before the expiration of ten years from the date of the approval of the application under subsection (b). "(ii) If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved after the date of the enactment of this subsection, no application may be submitted under this subsection which refers to the drug for which the subsection (b) application was submitted before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in subclause (IV) of paragraph (2)(A)(vii). The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (B)(iii) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application. "(iii) If an application submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under subsection (b), is approved after the date of enactment of this subsection and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under this subsection for the conditions of approval of such drug in the subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) for such drug. "(iv) If a supplement to an application approved under subsection (b) is approved after the date of enactment of this subsection and the supplement contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the

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 PUBLIC LAW 98-417—SfiPf. 24, 1984

98 STAT. 1591

supplement, the Secretary may not make the approval of an application submitted under this subsection for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b). "(v) If an application (or supplement to an application) submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application under subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this subsection, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted or which refers to a change approved in a supplement to the subsection (b) application effective before the expiration of two years from the date of enactment of this subsection. "(5) If a drug approved under this subsection refers in its approved application to a drug the approval of which was withdrawn or "suspended for grounds described in the first sentence of subsection (e) or was withdrawn or suspended under this paragraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this subsection shall be withdrawn or suspended— "(A) for the same period as the withdrawal or suspension under subsection (e) or this paragraph, or "(B) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. "(6)(A)(i) Within sixty days of the date of the enactment of this subsection, the Secretary shall publish and make available to the public— "(I) a list in alphabetical order of the official and proprietary name of each drug which has been approved for safety and effectiveness under subsection (c) before the date of the enactment of this subsection; "(II) the date of approval if the drug is approved after 1981 and the number of the application which was approved; and "(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are required for applications filed under this subsection which will refer to the drug published. "(ii) Every thirty days after the publication of the first list under clause (i) the Secretry shall revise the list to include each drug which has been approved for safety and effectiveness under subsection (c) or approved under this subsection during the thirty-day period. "(iii) When patent information submitted under subsection (b) or (c) respecting a drug included on the list is to be published by the Secretary the Secretary shall, in revisions made under clause (ii), include such information for such drug. "(B) A drug approved for safety and effectiveness under subsection (c) or approved under this subsection shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the date of its approval or the date of enactment, whichever is later. "(C) If the approval of a drug was withdrawn or suspended for grounds described in the first sentence of subsection (e) or was withdrawn or suspended under paragraph (5) or if the Secretary

Approved-drug list. Public availability.

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text:
Page:United States Statutes at Large Volume 98 Part 2.djvu/432

 98 STAT. 1592

Federal Register, publication.

Claims. 21 USC 355.

Public information.

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984

determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list— "(i) for the same period as the withdrawal or suspension under subsection (e) or paragraph (5), or "(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. A notice of the removal shall be published in the Federal Register. "(7) For purposes of this subsection: "(A) The term 'bioavailability' means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action. "(B) A drug shall be considered to be bioequivalent to a listed drug if— "(i) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or "(ii) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses and the difference from the listed drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.". SEC. 102. (a)(1) Section 505(b) of such Act if amended by adding at the end the following: "The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. Upon approval of the application, the Secretary shall publish information submitted under the two preceding sentences.". (2) Section 505(c) of such Act is amended by inserting "(1)" after "(c)", by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and by adding at the end the following: "(2) If the patent information described in subsection (b) could not be filed with the submission of an application under subsection (b) because the application was filed before the patent information was required under subsection (b) or a patent was issued after the application was approved under such subsection, the holder of an

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Page:United States Statutes at Large Volume 98 Part 2.djvu/433

 PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1593

approved application shall file with the Secretary the patent number and the expiration date of any patent which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an approved application could not file patent information under subsection (b) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than thirty days after the date of the enactment of this sentence, and if the holder of an approved application could not file patent information under subsection (b) because no patent had been issued when an application was filed or approved, the holder shall file such information under this subsection not later than thirty days after the date the patent involved is issued. Upon the submission of patent information under this subsection, the Secretary shall publish it.". (3)(A) The first sentence of section 505(d) of such Act is amended by redesignating clause (6) as clause (7) and inserting after clause (5) the following: "(6) the application failed to contain the patent information prescribed by subsection (b); or". (B) The first sentence of section 505(e) of such Act is amended by redesignating clause (4) as clause (5) and inserting after clause (3) the following: "(4) the patent information prescribed by subsection (c) was not filed within thirty days after the receipt of written notice from the Secretary specifying the failure to file such information; or". (b)(1) Section 505(a) of such Act is amended by inserting "or (j)" after "subsection (b)". (2) Section 505(c) of such Act is amended by striking out "this subsection" and inserting in lieu thereof "subsection (b)". (3) The second sentence of section 505(e) of such Act is amended by inserting "submitted under subsection (b) or (j)" after "an application". (4) The second sentence of section 505(e) is amended by striking out "(j)" each place it occurs in clause (1) and inserting in lieu thereof "(k)". (5) Section 505(k)(l) of such Act (as so redesignated) is amended by striking out "pursuant to this section" and inserting in lieu thereof "under subsection (b) or (j)". (6) Subsections (a) and (b) of section 527 of such Act are each amended by striking out "505(b)" each place it occurs and inserting in lieu thereof "505". SEC. 103. (a) Section 505(b) of such Act is amended by inserting "(1)" after "(b)", by redesignating clauses (1) through (6) as clauses (A) through (F), respectively, and by adding at the end the following: "(2) An application submitted under paragraph (1) for a drug for which the investigations described in clause (A) of such paragraph and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted shall also include— "(A) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking

Public information. 21 USC 355.

Ante, p. 1592.

Supra.

Ante, p. 1585.

21 USC 360cc.

Ante, p. 1592.

eiaims.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/434

 98 STAT. 1594

Claims.

Marketing.

Ante, p. 1592. Effective dates.

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984

approval under this subsection and for which information is required to be filed under paragraph (1) or subsection (c)— "(i) that such patent information has not been filed, "(ii) that such patent has expired, "(iii) of the date on which such patent will expire, or "(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and "(B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted information was filed under paragraph (1) or subsection (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. "(3)(A) An applicant who makes a certification described in paragraph (2)(A)(iv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to— "(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and "(ii) the holder of the approved application under subsection (b) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice. "(B) The notice referred to in subparagraph (A) shall state that an application has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed. "(C) If an application is amended to include a certification described in paragraph (2)(A)(iv), the notice required by subparagraph (B) shall be given when the amended application is submitted.", (b) Section 505(c) of such Act (as amended by section 102(a)(2)) is amended by adding at the end the following: "(3) The approval of an application filed under subsection 0>) which contains a certification required by paragraph (2) of such subsection shall be made effective on the last applicable date determined under the following: "(A) If the applicant only made a certification described in clause (i) or (ii) of subsection (b)(2)(A) or in both such clauses, the approval may be made effective immediately. (B) If the applicant made a certification described in clause (iii) of subsection (b)(2)(A), the approval may be made effective on the date certified under clause (iii). "(C) If the applicant made a certification described in clause (iv) of subsection (b)(2)(A), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (3)(B) is received. If such an action is brought before the expiration of such days, the approval may be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (3)(B) or such shorter or longer period as the court may order because

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Page:United States Statutes at Large Volume 98 Part 2.djvu/435

 PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1595

either party to the action failed to reasonably cooperate in expediting the action, except that— "(i) if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval may be made effective on the date of the court decision, "(ii) if before the expiration of such period the court decides that such patent has been infringed, the approval may be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, United States Code, or "(iii) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision. In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of forty-five days from the date the notice made under paragraph (3)(B) is received, no action may be brought under section 2201 of title 28, United States Code, for a declaratory judgment with respect to the patent. Any action brought under such section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business. "(D)(i) If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this subsection, the Secretary may not make the approval of another application for a drug for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted effective before the expiration of ten years from the date of the approval of the application previously approved under subsection (b). "(ii) If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved after the date of the enactment of this clause, no application which refers to the drug for which the subsection (b) application was submitted and for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted may be submitted under subsection (b) before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under subsection (b) after the expiration of four years from the date of the approval of the subsection (b)

Post, p. 1603.

Post, p. 1597.

Prohibitions.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/436

 98 STAT. 1596

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984 application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (b)(2)(A). The approval of such an application shall be made effective in accordance with this paragraph except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (C) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application. "(iii) If an application submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under subsection (b), is approved after the date of the enactment of this clause and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b) for the conditions of approval of such drug in the approved subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) if the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. "(iv) If a supplement to an application approved under subsection (b) is approved after the date of enactment of this clause and the supplement contains reports of new clinical investigations (other than bioavailabilty studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection (b) for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b) if the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. "(v) If an application (or supplement to an application) submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application under subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this clause, the Secretary may not make the approval of an application submitted under this subsection and for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted and which refers to the

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Page:United States Statutes at Large Volume 98 Part 2.djvu/437

 PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1597

drug for which the subsection (b) application was submitted effective before the expiration of two years from the date of enactment of this clause.". SEC. 104. Section 505 of such Act is amended by adding at the end the following: "(1) Safety and effectiveness data and information which has been submitted in an application under subsection (b) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— "(1) if no work is being or will be undertaken to have the application approved, "(2) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, "(3) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, "(4) if the Secretary has determined that such drug is not a new drug, or "(5) upon the effective date of the approval of the first application under subsection (j) which refers to such drug or upon the date upon which the approval of an application under subsection (j) which refers to such drug could be made effective if such an application had been submitted. "(m) For purposes of this section, the term 'patent' means a patent issued by the Patent and Trademark Office of the Department of Commerce.". SEC. 105. (a) The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by sections 101, 102, and 103 of this Act, within one year of the date of enactment of this Act. (b) During the period beginning sixty days after the date of the enactment of this Act and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new drug applications may be submitted in accordance with the provisions of section 314.2 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 505(c) of the Federal Food, Drug, and Cosmetic Act before the date of the enactment of this Act. If any such provision is inconsistent with the requirements of section 505(j) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall consider the application under the applicable requirements of such section. The Secretary of Health and Human Services may not approve such an abbreviated new drug application which is filed for a drug which is described in sections 505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and Cosmetic Act except in accordance with such section. SEC. 106. Section 2201 of title 28, United States Code, is amended by inserting "(a)" before "In a case" and by adding at the end the following: "(b) For limitations on actions brought with respect to drug patents see section 505 of the Federal Food, Drug, and Cosmetic Act.".

Ante, p. 1585. Public availability.

Regulations. 21 USC 355 note.

Ante, pp. 1592-1594. Ante, p. 1592.

Ante, p. 1594.

Ante, p. 1585.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/438

 98 STAT. 1598

PUBLIC LAW 98-417—SEPT. 24, 1984 TITLE II—PATENT EXTENSION

SEC. 201. (a) Title 35 of the United States Code is amended by adding the following new section immediately after section 155A: 35 USC 156. Claims.

Marketing.

Claims.

"§ 156. Extension of patent term "(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent if— "(1) the term of the patent has not expired before an application is submitted under subsection (d) for its extension; "(2) the term of the patent has never been extended; "(3) an application for extension is submitted by the owner of record of the patent or its agent and in accordance with the requirements of subsection (d); "(4) the product has been subject to a regulatory review period before its commercial marketing or use; "(5)(A) except as provided in subparagraph (B), the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred; or "(B) in the case of a patent which claims a method of manufacturing the product which primarily uses recombinant DNA technology in the manufacture of the product, the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent. The product referred to in paragraphs (4) and (5) is hereinafter in this section referred to as the 'approved product*. "(b) The rights derived from any patent the term of which is extended under this section shall during the period during which the patent is extended— "(1) in the case of a patent which claims a product, be limited to any use approved for the approved product before the expiration of the term of the patent under the provision of law under which the applicable regulatory review occurred; "(2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the approved product before the expiration of the term of the patent under the provision of law under which the applicable regulatory review occurred; and "(3) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the approved product. "(c) The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued, except that— "(1) each period of the regulatory review period shall be reduced by any period determined under subsection (d)(2)(B) during which the applicant for the patent extension did not act with due diligence during such period of the regulatory review period;

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 PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1599

"(2) after any reduction required by paragraph (1), the period of extension shall include only one-half of the time remaining in the periods described in paragraphs (l)(B)(i), (2)(B)(i), and (3)(B)(i) of subsection (g); "(3) if the period remaining in the term of a patent after the date of the approval of the approved product under the provision of law under which such regulatory review occurred when added to the regulatory review period as revised under paragraphs (1) and (2) exceeds fourteen years, the period of extension shall be reduced so that the total of both such periods does not exceed fourteen years; and "(4) in no event shall more than one patent be extended for the same regulatory review period for any product. "(d)(1) To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Commissioner. Such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use. The application shall contain— "(A) the identity of the approved product and the Federal statute under which regulatory review occurred; "(B) the identity of the patent for which an extension is being sought and the identity of each claim of such patent which claims the approved product or a method of using or manufacturing the approved product; "(C) information to enable the Commissioner to determine under subsections (a) and (b) the eligibility of a patent for extension and the rights that will be derived from the extension and information to enable the Commissioner and the Secretary of Health and Human Services to determine the period of the extension under subsection (g); "(D) a brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities; and "(E) such patent or other information as the Commissioner may require. "(2)(A) Within sixty days of the submittal of an application for extension of the term of a patent under paragraph (1), the Commissioner shall notify the Secretary of Health and Human Services if the patent claims any human drug product, a medical device, or a food additive or color additive or a method of using or manufacturing such a product, device, or additive and if the product, device, and additive are subject to the Federal Food, Drug, and Cosmetic Act, of the extension application and shall submit to the Secretary a copy of the application. Not later than thirty days after the receipt of an application from the Commissioner, the Secretary shall review the dates contained in the application pursuant to paragraph (1)(C) and determine the applicable regulatory review period, shall notify the Commissioner of the determination, and shall publish in the Federal Register a notice of such determination. "(B)(i) If a petition is submitted to the Secretary under subparagraph (A), not later than one hundred and eighty days after the publication of the determination under subparagraph (A), upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review

Prohibition.

21 USC 301. Federal Register, publication.

Regulations.

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Page:United States Statutes at Large Volume 98 Part 2.djvu/440

 98 STAT. 1600

Prohibition.

Federal Register, publication. Hearing.

Federal Register, publication.

Records.

21 USC 301.

PUBLIC LAW 98-417—SEPT. 24, 1984

period, the Secretary shall, in accordance with regulations promulgated by the Secretary determine if the applicant acted with due diligence during the applicable regulatory review period. The Secretary shall make such determination not later than ninety days after the receipt of such a petition. The Secretary may not delegate the authority to make the determination prescribed by this subparagraph to an office below the Office of the Commissioner of Food and Drugs. "(ii) The Secretary shall notify the Commissioner of the determination and shall publish in the Federal Register a notice of such determination together with the factual and legal basis for such determination. Any interested person may request, within the sixtyday period beginning on the publication of a determination, the Secretary to hold an informal hearing on the determination. If such a request is made within such period, the Secretary shall hold such hearing not later than thirty days after the date of the request, or at the request of the person making the request, not later than sixty days after such date. The Secretary shall provide notice of the hearing to the owner of the patent involved and to any interested person and provide the owner and any interested person an opportunity to participate in the hearing. Within thirty days after the completion of the hearing, the Secretary shall affirm or revise the determination which was the subject of the hearing and notify the Commissioner of any revision of the determination and shall publish any such revision in the Federal Register. "(3) For the purposes of paragraph (2)(B), the term 'due diligence' means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period. "(4) An application for the extension of the term of a patent is subject to the disclosure requirements prescribed by the Commissioner. "(e)(1) A determination that a patent is eligible for extension may be made by the Commissioner solely on the basis of the representations contained in the application for the extension. If the Commissioner determines that a patent is eligible for extension under subsection (a) and that the requirements of subsection (d) have been complied with, the Commissioner shall issue to the applicant for the extension of the term of the patent a certificate of extension, under seal, for the period prescribed by subsection (c). Such certificate shall be recorded in the official file of the patent and shall be considered as part of the original patent. "(2) If the term of a patent for which an application has been submitted under subsection (d) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Commissioner shall extend, until such determination is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension. "(f) For purposes of this section: "(1) The term 'product' means: "(A) A human drug product. "(B) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act. "(2) The term 'human drug product' means the active ingredient of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and

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Page:United States Statutes at Large Volume 98 Part 2.djvu/441

 PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1601

Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient. "(3) The term 'major health or environmental effects test' means a test which is reasonably related to the evaluation of the health or environmental effects of a product, which requires at least six months to conduct, and the data from which is submitted to receive permission for commercial marketing or use. Periods of analysis or evaluation of test results are not to be included in determining if the conduct of a test required at least six months. "(4)(A) Any reference to section 351 is a reference to section 351 of the Public Health Service Act. "(B) Any reference to section 503, 505, 507, or 515 is a reference to section 503, 505, 507, or 515 of the Federal Food, Drug, and Cosmetic Act. "(5) The term 'informal hearing' has the meaning prescribed for such term by section 201(y) of the Federal Food, Drug, and Cosmetic Act. "(6) The term 'patent' means a patent issued by the United States Patent and Trademark Office. "(g) For purposes of this section, the term 'regulatory review period' has the following meanings: "(I)(A) In the case of a product which is a human drug product, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a human drug product is the sum of— "(i) the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 became effective for the approved humsin drug product and ending on the date an application was initially submitted for such drug product under section 351, 505, or 507, and "(ii) the period beginning on the date the application was initially submitted for the approved human drug product under section 351, subsection (b) of section 505, or section 507 and ending on the date such application was approved under such section. "(2)(A) In the case of a product which is a food additive or color additive, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a food or color additive is the sum of—"(i) the period beginning on the date a major health or environmental effects test on the additive was initiated and ending on the date a petition was initially submitted with respect to the product under the Federal Fodd, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and "(ii) the period beginning on the date a petition was initially submitted with respect to the product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and ending on the date such regulation became effective or, if objections were filed to such regulation, ending on the date such objections were resolved and commercial marketing was

21 USC 301; 42 USC 201 note.

42 USC 262. 21 USC 353, 355, ^57,360e. 21 USC 321.

21 USC 355, 357.

Ante, pp. 1592, i^^^.

>

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Page:United States Statutes at Large Volume 98 Part 2.djvu/442

 98 STAT. 1602

21 USC 360e.

Fees.

PUBLIC LAW 98-417—SEPT. 24, 1984

permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, ending on the date such proceedings were finally resolved and commercial marketing was permitted. "(3)(A) In the case of a product which is a medical device, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a medical device is the sum of^ "(i) the period beginning on the date a clinical investigation on humans involving the device was begun and ending on the date an application was initially submitted with respect to the device under section 515, and "(ii) the period beginning on the date an application was initially submitted with respect to the device under section 515 and ending on the date such application was approved under such Act or the period beginning on the date a notice of completion of a product development protocol was initially submitted under section 515(f)(5) and ending on the date the protocol was declared completed under section 515(f)(6). "(4) A period determined under any of the preceding paragraphs is subject to the following limitations: "(A) If the patent involved was issued after the date of the enactment of this section, the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years. "(B) If the patent involved was issued before the date of the enactment of this section and— "(i) no request for an exemption described in paragraph (1)(B) was submitted, "(ii) no major health or environmental effects test described in paragraph (2) was initiated and no petition for a regulation or application for registration described in such paragraph was submitted, or "(iii) no clinical investigation described in paragraph (3) was begun or product development protocol described in such paragraph was submittted, before such date for the approved product the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years. "(C) If the patent involved was issued before the date of the enactment of this section and if an action described in subparagraph (B) was taken before the date of the enactment of this section with respect to the approved product and the commercial marketing or use of the product has not been approved before such date, the period of extension determined on the basis of the regulatory review period determined under such paragraph may not exceed two years. "(h) The Commissioner may establish such fees as the Commissioner determines appropriate to cover the costs to the Office of receiving and acting upon applications under this section.". (b) The analysis for chapter 14 of title 35 of the United States Code is amended by adding at the end thereof the following:

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"156. Extension of patent term.".

SEC. 202. Section 271 of title 35, United States Code, is amended by adding at the end the following: "(e)(1) It shall not be an act of infringement to make, use, or sell a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913)) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs. "(2) It shall be an act of infringement to submit an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent, if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug claimed in a patent or the use of which is claimed in a patent before the expiration of such patent. "(3) In any action for patent infringement brought under this section, no injunctive or other relief may be granted which would prohibit the making, using, or selling of a patented invention under paragraph (1). "(4) For an act of infringement described in paragraph (2)— "(A) the court shall order the effective date of any approval of the drug involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed, "(B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, or sale of an approved drug, and "(C) damages or other monetary relief may be awarded against an infringer only if there has been commercial manufacture, use, or sale of an approved drug. The remedies prescribed by subparagraphs (A), (B), and (C) are the only remedies which may be granted by a court for an act of infringement described in paragraph (2), except that a court may award attorney fees under section 285.". SEC. 203. Section 282 of title 35, United States Code, is amended by adding at the end the following: "Invalidity of the extension of a patent term or any portion thereof under section 156 of this title because of the material failure— "(1) by the applicant for the extension, or "(2) by the Commissioner, to comply with the requirements of such section shall be a defense in any action involving the infringement of a patent during the period of the extension of its term and shall be pleaded. A due diligence determination under section 156(d)(2) is not subject to review in such an action.".

Marketing.

TITLE III—AMENDMENTS TO THE TEXTILE FIBER PRODUCTS IDENTIFICATION ACT AND THE WOOL PRODUCTS LABELING ACT OF 1939

Labeling. Hosiery.

SEC. 301. Subsection (b) of section 4 of the Textile Fiber Products Identification Act (15 U.S.C. 70b) is amended by adding at the end thereof the following new paragraph:

21 USC 301, 151 note.

Ante, p. 1585. Ante, p. 1593.

35 USC 285. Ante, p. 1598.

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PUBLIC LAW 98-417—SEPT. 24, 1984

"(5) If it is a textile fiber product processed or manufactured in the United States, it be so identified.". SEC. 302. Subsection (e) of section 4 of the Textile Fiber Products Identification Act (15 U.S.C. 70b) is amended to read as follows: "<e) For purposes of this Act, in addition to the textile fiber products contained therein, a package of textile fiber products intended for sale to the ultimate consumer shall be misbranded unless such package has affixed to it a stamp, tag, label, or other means of identification bearing the information required by subsection (b), with respect to such contained textile fiber products, or is transparent to the extent it allows for the clear reading of the stamp, tag, label, or other means of identification on the textile fiber product, or in the case of hosiery items, this section shall not be construed as requiring the affixing of a stamp, tag, label, or other means of identification to each hosiery product contained in a package if (1) such hosiery products are intended for sale to the ultimate consumer in such package, (2) such package has affixed to it a stamp, tag, label, or other means of identification bearing, with respect to the hosiery products contained therein, the information required by subsection (b), and (3) the information on the stamp, tag, label, or other means of identification affixed to such package is equally applicable with respect to each textile fiber product contained therein.". SEC. 303. Section 4 of the Textile Fiber Products Identification Act (15 U.S.C. 70b) is amended by adding at the end thereof the following new subsections: "(i) For the purposes of this Act, a textile fiber product shall be considered to be falsely or deceptively advertised in any mail order catalog or mail order promotional material which is used in the direct sale or direct offering for sale of such textile fiber product, unless such textile fiber product description states in a clear and conspicuous manner that such textile fiber product is processed or manufactured in the United States of America, or imported, or both. "(j) For purposes of this Act, any textile fiber product shall be misbranded if a stamp, tag, label, or other identification conforming to the requirements of this section is not on or affixed to the inside center of the neck midway between the shoulder seams or, if such product does not contain a neck, in the most conspicuous place on the inner side of such product, unless it is on or affixed on the outer side of such product, or in the case of hosiery items on the outer side of such product or package.". SEC. 304. Paragraph (2) of section 4(a) of the Wool Products Labeling Act of 1939 (15 U.S.C. 68b(a)(2)) is amended by adding at the end thereof the following new subparagraph: "(D) the name of the country where processed or manuSEC. 305. Section 4 of the Wool Products Labeling Act of 1939 (15 U.S.C. 68b) is amended by adding at the end thereof the following new subsections: "(e) For the purposes of this Act, a wool product shall be considered to be falsely or deceptively advertised in any mail order promotional material which is used in the direct sale or direct offering for sale of such wool product, unless such wool product description states in a clear and conspicuous manner that such wool product is processed or manufactured in the United States of America, or imported, or both.

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98 STAT. 1605

"(f) For purposes of this Act, any wool product shall be misbranded if a stamp, tag, label, or other identification conforming to the requirements of this section is not on or affixed to the inside center of the neck midway between the shoulder seams or, if such product does not contain a neck, in the most conspicuous place on the inner side of such product, unless it is on or affixed on the outer side of such product or in the case of hosiery items, on the outer side of such product or package.". SEC. 306. Section 5 of the Wool Products Labeling Act of 1939 (15 U.S.C. 68c) is amended— (1) by striking out "Any person" in the first paragraph and inserting in lieu thereof "(a) Any person", (2) by striking out "Any person" in the second paragraph and inserting in lieu thereof "(b) Any person", and (3) by inserting after subsection (b) (as designated by this section) the following new subsection: "(c) For the purposes of subsections (a) and (b) of this section, any package of wool products intended for sale to the ultimate consumer shall also be considered a wool product and shall have affixed to it a stamp, tag, label, or other means of identification bearing the information required by section 4, with respect to the wool products contained therein, unless such package of wool products is transparent to the extent that it allows for the clear reading of the stamp, tag, label, or other means of identification affixed to the wool product, or in the case of hosiery items this section shall not be construed as requiring the affixing of a stamp, tag, label, or other means of identification to each hosiery product contained in a package if (1) such hosiery products are intended for sale to the ultimate consumer in such package, (2) such package has affixed to it a stamp, tag, label, or other means of identification bearing, with respect to the hosiery products contained therein, the information required by subsection (4), and (3) the information on the stamp, tag, label, or other means of identification affixed to such package is equally applicable with respect to each hosiery product contained therein.". SEC. 307. The amendments made by this title shall be effective ninety days after the date of enactment of this Act. Approved September 24, 1984.

LEGISLATIVE HISTORY—S. 1538 (H.R. 3605): HOUSE REPORT No. 98-857 accompanying H.R. 3605, Pt. 1 (Comm. on Energy and Commerce) and Pt. 2 (Comm. on the Judiciary). SENATE REPORT No. 98-547 (Comm. on the Judiciary). CONGRESSIONAL RECORD, Vol. 130 (1984): June 29, considered and passed Senate. Sept. 6, considered and passed House, amended, in lieu of H.R. 3605. Sept. 12, Senate concurred in House amendments. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 20, No. 39 (1984): Sept. 24, Presidential statement.

Effective date, 15 USC 68b note.

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 98 STAT. 1606

PUBLIC LAW 98-418—SEPT. 25, 1984

Public Law 98-418 98th Congress

•

'

Joint Resolution Sept. 25, 1984 [S.J. Res. 275]

To designate the month of October 1984 as "National Spina Bifida Month".

Whereas spina bifida is a birth defect in the spinal column which occurs in one of every one thousand births in the United States; Whereas spina bifida is the most common crippler of newborns, resulting when one or more bones in the back (vertebrae) fail to close completely during prenatal development; Whereas while the cause of spina bifida is not known, it appears to be the result of multiple environmental and genetic factors; Whereas although most of the March of Dimes and Easter Seal poster children have spina bifida, many people have not heard of the defect; Whereas only a few cities in the United States have proper care centers and specialized professionals that can provide the most effective, aggressive treatment for children and adults with spina bifida; and Whereas an increase in the national awareness of the problem of spina bifida may stimulate the interest and concern of the American people, which may lead, in turn, to increased research and eventually to the discovery of a cure for spina bifida: Now, therefore, be it Resolved by the Senate and House of Representatives of the United States of America in Congress assembled. That the month of October 1984 is designated "National Spina Bifida Month", and the President is authorized and requested to issue a proclamation calling upon the people of the United States to observe that month with appropriate ceremonies and activities. Approved September 25, 1984.

LEGISLATIVE HISTORY—S.J. Res. 275: CONGRESSIONAL RECORD, Vol. 130 (1984): Aug. 10, considered and passed Senate. Sept. 12, considered and passed House.

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 PUBLIC LAW 98-419—SEPT. 25, 1984

98 STAT. 1607

Public Law 98-419 98th Congress An Act To amend the Deepwater Port Act of 1974, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Deepwater Port Act Amendments of 1984". AMENDMENT, TRANSFER, OR RENEWAL OF UCENSE

SEC. 2. (a) Section 3(4) of the Deepwater Port Act of 1974 (33 U.S.C. 1502(4)) is amended to read: "(4) 'application' means an application submitted under this Act for a license for the ownership, construction, and operation of a deepwater port;". (b) Section 4(b) of the Deepwater Port Act of 1974 (33 U.S.C. 15030))) is amended to read: "(b) The Secretary may— "(1) on application, issue a license for the ownership, construction, and operation of a deepwater port; and "(2) on petition of the licensee, amend, transfer, or reinstate a license issued under this Act.". (c) Section 4(f) of the Deepwater Port Act of 1974 (33 U.S.C. 1503(f)) is amended to read: "(f) The Secretary may amend, transfer, or reinstate a license issued under this Act if the amendment, transfer, or reinstatement is consistent with the findings made at the time the license was issued.". (d) Section 4(h) of the Deepwater Port Act of 1974 (33 U.S.C. 153(h)) is amended to read: "(h) A license issued under this Act remains in effect unless suspended or revoked by the Secretary or until surrendered by the licensee.". (e) Section 4(e)(1) of the Deepwater Port Act of 1974 (33 U.S.C. 153(e)(l)) is amended by inserting at the end thereof: "On petition of a licensee, the Secretary shall review any condition of a license issued under this Act to determine if that condition is uniform, insofar as practicable, with the conditions of other Hcenses issued under this Act, reasonable, and necessary to meet the objectives of this Act. The Secretary shall amend or rescind any condition that is no longer necessary or otherwise required by any Federal department or agency under this Act.". (f) The first sentence of section 5(g) of the Deepwater Port Act of 1974 (33 U.S.C. 1504(g)) is amended by striking "issued, transferred, or renewed" and inserting "issued". (g) The first sentence of section 7(a) of the Deepwater Port-Act of 1974 (33 U.S.C. 1506(a)) is amended by striking "issue, transfer, or renew" and inserting "issue". (h) Section 7(b)(l) of the Deepwater Port Act of 1974 (33 U.S.C. 1506(b)(1)) is amended:

Sept. 25, 1984 [S. 1546] Deepwater Port Act Amendments of 1984. Vessels. 33 USC 1501 note.

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PUBLIC LAW 98-419—SEPT. 25, 1984 (1) by striking the first sentence and inserting: "The Secretary shall transmit promptly to the Attorney General and the Federal Trade Commission a complete copy of each application for issuance of a license or a petition for the amendment, transfer, or reinstatement of a license that is received."; and (2) in the second sentence, by inserting immediately after the word "hearing" the phrase "on license application". ECONOMIC DEREGULATION

49 USC 10101. Petroleum and petroleum products.

Law enforcement.

SEC. 3. (a) Section 8 of the Deepwater Port Act of 1974 (33 U.S.C. 1507) is amended to read: "SEC. 8. (a) A deepwater port and a storage facility serviced directly by that deepwater port shall operate as a common carrier under applicable provisions of part I of the Interstate Commerce Act and subtitle IV of title 49, United States Code, except as provided by subsection (b) of this section. "(b) A licensee under this Act shall accept, transport, or convey without discrimination all oil delivered to the deepwater port with respect to which its license is issued. However, a licensee is not subject to common carrier regulations under subsection (a) of this section when that licensee— "(1) is subject to effective competition for the transportation of oil from alternative transportation systems; and "(2) sets its rates, fees, charges, and conditions of service on the basis of competition, giving consideration to other relevant business factors such as the market value of services provided, licensee's cost of operation, and the licensee's investment in the deepwater port and a storage facility, and components thereof, serviced directly by that deepwater port. "(c) When the Secretary has reason to believe that a licensee is not in compliance with this section, the Secretary shall commence an appropriate proceeding before the Federal Energy Regulatory Commission or request the Attorney General to take appropriate steps to enforce compliance with this section and, when appropriate, to secure the imposition of appropriate sanctions. In addition, the Secretary may suspend or revoke the license of a licensee not complying with its obligations under this section.". SUSPENSION OF FEE COLLECTION AND SUBROGATION

Claims.

Effective dates. Ante, p. 1607.

SEC. 4. (a) Section 18 of the Deepwater Port Act of 1974 (33 U.S.C. 1517) is amended as follows: (1) In the first sentence of subsection (d), following the words "deepwater port" the first time they appear, insert "while located in the safety zone". (2) In subsection (f)(3), strike the third and fourth sentences and insert: "These collections shall cease after the date of enactment of the Deepwater Port Act Amendments of 1984, unless there are adjudicated claims against the Fund to be satisfied. The Secretary may order the collection of the fee to be resumed when the unobligated balance of the Fund as reduced by the unliquidated debts to the United States Treasury is less than $4,000,000. Any collection of fees ordered by the Secretary under the preceding sentence shall cease whenever the unobligated balance of the Fund as reduced by the unliquidated debts to the United States Treasury exceeds $4,000,000. The Fund

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may borrow from the United States Treasury at an interest rate to be determined by the Secretary of the Treasury amounts sufficient to maintain the available balance in the Fund at $4,000,000, but only to such extent and in such amounts as are provided in advance in appropriation Acts. Such amounts shall remain available until expended.". (3) In the eighth sentence of subsection (f)(3), as amended by this subsection, after the word "than", insert "the amount the Secretary determines is needed to draw upon under subsection (c)(3) of this section or". (4) In the tenth sentence of subsection (f)(3), as amended by this subsection, after the word "needed", insert "to draw upon under subsection (c)(3) of this section or". (5) In subsection (h)(2), insert at the end thereof: "In that event, the owner and operator of the vessel are jointly and severally liable for cleanup costs and damages resulting from that discharge in the same manner and to the same extent as under subsection (d) of this section.. (6) In subsection (h)(3), insert at the end thereof: "When the Fund under this subsection is subrogated to the right of any person entitled to recovery against thfe owner or operator of a vessel, that owner and operator are jointly and severally liable for cleanup costs and damages resulting from that discharge in the same manner and to the same extent as under subsection (d) of this section.". RELATIONSHIP TO OTHER LAWS

SEC. 5. (a) Section 19(a) of the Deepwater Port Act of 1974 (33 Vessels. U.S.C. 1518(a)) is amended by adding at the end thereof: "(3) The Secretary of State shall notify the government of each foreign state having vessels registered under its authority or flying its flag which may call at or otherwise utilize a deepwater port but which do not currently have an agreement in effect as provided in subsection (c)(2)(AKi) of this section that the United States intends to exercise jurisdiction over vessels calling at or otherwise utilizing a deepwater port and the persons on board such vessels. The Secretary of State shall notify the government of each such state that, absent its objection, its vessels will be subject to the jurisdiction of the United States whenever they— "(A) are calling at or otherwise utilizing a deepwater port; and "(B) are within the safety zone of such a deepwater port and are engaged in activities connected, associated, or potentially interfering with the use and operation of the deepwater port. The Secretary of State shall promptly inform licensees of deepwater ports of all objections received from governments of foreign states in response to notifications made under this paragraph.". (b) Section 19(c) of the Deepwater Port Act of 1974 (33 U.S.C. 1518(c)) is amended to read: "(c)(1) The jurisdiction of the United States shall apply to vessels of the United States and persons on board such vessels. The jurisdiction of the United States shall also apply to vessels, and persons on board such vessels, registered in or flying the flags of foreign states, whenever such vessels are— "(A) calling at or otherwise utilizing a deepwater port; and 31-194 - 0 - 86 - 15: QL. 3 Part 2

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