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 100 STAT. 3738

16 USC 932 note.

PUBLIC LAW 99-659—NOV. 14, 1986

Great Lakes, except that 1 of them must also be an official of Great Lakes State. "(2) The President shall appoint an alternate Commissioner who shall perform the duties of a Commissioner— "(A) until a vacancy referred to in subsection (b)(3) is filled; and "(B) in the event of the absence of a Commissioner from any meeting of the United States Section or the Commission. "(b)(1) Except as provided in paragraph (2), the term of office of Commissioners appointed under subsection (a)(1)(B) is 6 years. "(2) Of the Commissioners first appointed under subsection (a)(1)(B) after the date of the enactment of this subsection, 1 shall be appointed for a term of 2 years, 1 shall be appointed for a term of 4 years, and 1 shall be appointed for a term of 6 years. "(3) Whenever a vacancy occurs among Commissioners appointed under subsection (a)(1)(B), the President shall appoint an individual to fill that vacancy for the remainder of the applicable term.". (b) TRANSITION.—The term of office of each United States Commissioner on the Great Lakes Fishery Commission who is serving on the date of enactment of this Act is terminated (except the United States Government official appointed under section 3(a) of the Great Lakes Fishery Act of 1956 (16 U.S.C. 932(a), as in effect before the date of enactment). However, the individuals appointed to those terms shall continue to serve as Commissioners until the President makes appointments under section 3(b)(2) of the Act of 1956 (as added by subsection (a)), which appointments shall be made within 60 days after the date of enactment. (c) CONFORMING AMENDMENT.—Section 201 of the Act entitled

"An Act to amend the North Pacific Fisheries Act of 1954, and for other purposes", approved October 9, 1972 (22 U.S.C. 2672a) is amended by striking out "the Great Lakes Fishery Commission,". 15 USC 1511c.

SEC. 406. NOAA ESTUARINE PROGRAMS OFFICE.

(a) ESTABLISHMENT.—The Administrator of the National Oceanic and Atmospheric Administration (hereinafter in this section referred to as the "Administrator") shall establish within the Administration an Estuarine Programs Office. Ob) FUNCTIONS.—The Estuarine Programs Office shall— (1) develop and implement a national estuarine strategy for r the Administration that integrates the research, regulatory, and trusteeship responsibilities of the Administration; (2) coordinate the estuarine activities of the various organizations within the Administration, including activities in estuarine research and assessment, fisheries research, coastal management, and habitat conservation; (3) coordinate the estuarine activities of the Administration with the activities of other Federal and State agencies; and (4) provide technical assistance to the Administrator, to other Federal agencies, and to State and local government agencies in—

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V

(A) assessing the condition of estuaries; (B) identifying estuaries of critical national or regional importance; (C) identifying technical and management alternatives for the restoration and protection of estuarine resources; and

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100 STAT. 3739

(D) monitoring the implementation and effectiveness of estuarine management plans, (c) AUTHORIZATION.—There are authorized to be appropriated to the Administration not to exceed $500,000 for fiscal year 1987, $530,000 for fiscal year 1988, $560,000 for fiscal year 1989, and $600,000 for fiscal year 1990 to carry out the provisions of this section. SEC. 407. NOAA OFFICERS.

15 USC 1503b.

(a) UNDER SECRETARY.—There shall be in the Department of

Commerce an Under Secretary of Commerce for Oceans and Atmosphere who shall serve as the Administrator of the National Oceanic and Atmospheric Administration established by Reorganization Plan No. 4 of 1970 (5 U.S.C. App. 1) and perform such duties as the Secretary of Commerce shall prescribe. The Under Secretary shall be appointed by the President by and with the advice and consent of the Senate and shall be compensated at the rate now or hereafter provided for Level III of the Executive Schedule Pay Rates (5 U.S.C. 5314). Post, p. 3740. (b) ASSISTANT SECRETARY.—There shall be in the Department of 15 USC 1507c. Commerce, in addition to the Assistant Secretaries of Commerce provided by law before the date of enactment of this Act, one additional Assistant Secretary of Commerce who shall have the title Assistant Secretary of Commerce for Oceans and Atmosphere and shall serve as the Deputy Administrator of the National Oceanic and Atmospheric Administration established by Reorganization Plan No. 4 of 1970 (5 U.S.C. App. 1) and perform such duties and functions as the Under Secretary of Commerce for Oceans and Atmosphere shall prescribe. The Assistant Secretary for Oceans and Atmosphere shall be appointed by the President by and with the advice and consent of the Senate and shall be compensated at the rate now or hereafter provided for Level IV of the Executive Schedule Pay Rates (5 U.S.C. 5315). Post, p. 3740. (c) APPLICABILITY.—The individual serving on the date of enact- 15 USC 1503b note. ment of this Act— (A) as the Administrator of the National Oceanic and Atmospheric Administration shall also serve as the Under Secretary of Commerce for Oceans and Atmosphere until such time as a successor is appointed under subsection (a) of this section; and (B) as the Deputy Administrator of the National Oceanic and Atmospheric Administration shall also serve as the Assistant Secretary of Commerce for Oceans and Atmosphere until such time as a successor is appointed under subsection (h) of this section. (d) CHIEF SCIENTIST OF NOAA.—Section 2(d) of Reorganization 15 USC 1511 Plan No. 4 of 1970 (5 U.S.C. App. 1) is amended to read as follows: note. "(d) There shall be in the Administration a Chief Scientist of the President of U.S. National Oceanic and Atmospheric Administration who shall be appointed by the President, by and with the advice and consent of the Senate, and shall be compensated at the rate now or hereafter provided for Level V of the Executive Schedule Pay Rates (5 U.S.C. 5316). The Chief Scientist shall be the principal scientific adviser to Post, p. 3740. the Administrator, and shall perform such other duties as the Administrator may direct. The Chief Scientist shall be an individual who is, by reason of scientific education and experience, knowledge-

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


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 100 STAT. 3740

Ante, pp. 591, 708.

Ante, pp. 856, 867, 868.

Ante, p. 814.

PUBLIC LAW 99-659—NOV. 14, 1986

able in the principles of oceanic, atmospheric, or other scientific disciplines important to the work of the Administration.". (e) CONFORMING AMENDMENTS.—(1) Section 5314 of title 5, United States Code, is amended by striking "Administrator, National Oceanic and Atmospheric Administration." and inserting in lieu thereof "Under Secretary of Commerce for Oceans and Atmosphere, the incumbent of which also serves as Administrator of the National Oceanic and Atmospheric Administration.". (2) Section 5315 of title 5, United States Code, is amended— (A) by striking "Deputy Administrator, National Oceanic and Atmospheric Administration." and inserting in lieu thereof "Assistant Secretary of Commerce for Oceans and Atmosphere, the incumbent of which also serves as Deputy Administrator of the National Oceanic and Atmospheric Administration."; and (B) by striking "Associate Administrator, National Oceanic and Atmospheric Administration.". (3) Section 5316 of title 5, United States Code, is amended by adding at the end thereof the following: "Chief Scientist, National Oceanic and Atmospheric Administration.". SEC. 408. TRANSFER OF AUTHORITY FOR REIMBURSEMENT UNDER THE FISHERMEN'S PROTECTIVE ACT OF 1967.

Effective October 1, 1986, paragraph (1) of section 7(f) of the Fishermen's Protective Act of 1967 (22 U.S.C. 1977(0(1)) is amended to read as follows: "(1) the term 'Secretary' means the Secretary of State.". 16 USC 742c.

SEC. 409. FISHERIES LOAN FUND.

The third sentence of section 4(c) of the Fish and Wildlife Act of 1956 (16 U.S.C. 742(c)) is amended to read as follows: "Any funds received in the fisheries loan fund after September 30, 1986, shall be covered into the Treasury as miscellaneous receipts.". SEC. 410. CONVEYANCE AGREEMENT PROVISIONS.

(a) IN GENERAL.—Under the Agreement dated December 9, 1977, between the Commandant of the Coast Guard and Koniag, Incorporated, a regional native corporation, pursuant to Public Law 92203 (a copy of which is recorded beginning at Book 44, Page 179 of the Kodiak Recording District, Kodiak, Alaska) and any conveyance made under that Agreement, the rights or title conveyed to Koniag, Incorporated, shall be construed to include the following: eommunications (1) Under the Agreement, welding or other equipment or and telemachinery may be operated or maintained on lands conveyed to communications. Koniag, Incorporated, if the equipment or machinery does not cause harmful electromagnetic interference with the Coast Guard Holiday Beach receiver site or is operated or maintained under terms and conditions mutually agreeable to the Coast Guard and Koniag, Incorporated. Harmful electromagnetic interference is defined as radio frequency signals which disrupt or degrade communications reception performance. (2) The conveyance of the "old shipyard" includes the wharf and all lands of any nature beneath the wharf. (3) An access and utility easement is intended as part of the conveyance for Parcel 2, known as Cliff Point, which consists of— Highways. (A) a 100-foot wide access easement along the existing Bridges. access road or a location that is mutually agreeable to the

Uniformed services. Corporations. Alaska. 43 USC 1601 note.

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100 STAT. 3741

Coast Guard and Koniag, Incorporated, and includes the right to construct and operate an access road, bridges, guard rails, and other associated improvements; and ij; (B) a 40-foot wide utility easement adjacent to the access easement in paragraph (3)( A) of this subsection or a location that is mutually agreeable to the Coast Guard and Koniag, Incorporated. (4) The construction, maintenance, and operation of a dock facility or location of any structure or thing on the premises , ^^ ^ described in section (c) of Schedule 4 of the Agreement is not inconsistent with the easement for the barge landing easement and access to and from the barge landing area reserved by the United States Government (hereinafter referred to in this paragraph as the "Government"), if the dock facility is constructed ' or the structure or thing is located as approved by the Government. Approval by the Government is deemed to be granted if a proposal for the construction and location of the dock facility, '"' structure, or thing is submitted to the Government and— (A) the Government does not respond within 60 days of receipt of the proposal; or (B) if a response with recommendations for modification is submitted by the Government within 60 days of receipt of the proposal, the proposal is modified in a manner necessary to reasonably satisfy the requirements of the >: Government— (i) to use the dock facility for a barge landing area as contemplated by the easement; and (ii) to permit access to and from the barge loading area to public highways for the transportation of materials as specified in Agreement. (h) APPLICATION.—All rights or conveyances confirmed by this section are subject to the sanctions in the Agreement referred to in subsection (a). (c) IMPLEMENTATION.—The Commandant of the Coast Guard or Uniformed other appropriate Federal officer shall issue the appropriate correc- services, tive conveyance and perform any other appropriate ministerial or official act necessary to carry out the purposes of this section within 60 days after the date of the enactment of this title. SEC. 411. INCIDENTAL TAKING OF DEPLETED MARINE MAMMALS. (a) AMENDMENT OF THE MARINE MAMMAL PROTECTION ACT.—

Paragraph (5)(A) of section 101(a) of the Marine Mammal Protection Act of 1972 (16 U.S.C. 1371(a)(5)(A)) is amended— (1) by striking "that is not depleted"; (2) in clause (i)— (A) by striking "its habitat, and" and inserting in lieu thereof "will not have an unmitigable adverse impact"; and (B) by inserting "or, in the case of a cooperative agreement under both this Act and the Whaling Convention Act of 1949 (16 U.S.C. 916 et seq.), pursuant to section 112(c)" immediately after "or section 109(f)"; and (3) in clause (ii)(I), by inserting ", and on the availability of such species or stock for subsistence uses" immediately after "significance". Ob) STATEMENT BY THE SECRETARY.—Paragraph 4 of section 7(b) of the Endangered Species Act of 1973 (16 U.S.C. 1536(b)(4)) is amended—

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 100 STAT. 3742

Ante, p. 3741.

16 USC 1371, 1372.

PUBLIC LAW 99-659—NOV. 14, 1986

(1) by striking "and" at the end of subparagraph (A); (2) by inserting "and" after the semicolon at the end of subparagraph (B); and (3) by inserting after subparagraph (B) the following subparagraph: "(C) if an endangered species or threatened species of a marine mammal is involved, the taking is authorized pursuant to section 101(a)(5) of the Marine Mammal Protection Act of 1972;"; (4) by striking "and" at the end of clause (ii); (5) by redesignating clause (iii) as clause (iv) and by striking "clause (ii)" in that clause and inserting in lieu thereof "clauses (ii) and (iii)"; and (6) by inserting after clause (ii) the following new clause: "(iii) in the case of marine mammals, specifies those measures that are necessary to comply with section 101(a)(5) of the Marine Mammal Protection Act of 1972 with regard to such taking, and". (c) EXEMPTIONS.—Subsection (o) of section 7 of the Endangered Species Act of 1973 (16 U.S.C. 1536(o)) is amended— (1) in the matter preceding paragraph (1)— (A) by inserting ", sections 101 and 102 of the Marine Mammal Protection Act of 1972," immediately before "or any regulation"; and (B) by striking "either" and inserting in lieu thereof "any"; and (2) in paragraph (2)— (A) by striking "(b)(4)(iii)" and inserting in lieu thereof "a))(4)(iv)"; and ' (B) by inserting "prohibited" immediately before "taking of the species". Approved November 14, 1986.

LEGISLATIVE HISTORY—S. 991: SENATE REPORTS: No. 99-67 (Comm. on Commerce, Science, and Transportation). CONGRESSIONAL RECORD: Vol. 131 (1985): Oct. 2, considered and passed Senate. Vol. 132 (1986): Aug. 12, considered and passed House, amended. Oct. 15, Senate concurred in House amendments with amend' , ments. Oct. 16, House concurred in Senate amendments with amendments. Oct. 18, Senate concurred in House amendments. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 22 (1986): Nov. 14, Presidential statement.

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 PUBLIC LAW 99-660—NOV. 14, 1986 Public Law 99-660 99th Congress

100 STAT. 3743

An Act

To require States to develop, establish, and implement State comprehensive mental health plans.

Nov. 14, 1986 [S. 1744]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

TITLE I—DRUG EXPORTS SEC. 101. SHORT TITLE, REFERENCE.

Drug Export j Amendments Act of 1986. 21 USC 301 note.

(a) SHORT TITLE.—This title may be cited as the "Drug Export Amendments Act of 1986". (b) REFERENCE.—Whenever in this title an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be a reference to a section or other provision of the Federal Food, Drug, and Cosmetic Act.

21 USC 301.

SEC. 102. EXPORT AUTHORITY.

Chapter VIII is amended— (1) by inserting after the chapter heading the following:

21 USC 381 et seq.

"IMPORTS AND EXPORTS", and

(2) by inserting after section 801 the following: "EXPORTS OF CERTAIN UNAPPROVED PRODUCTS

"SEC. 802. (a) A drug (including a biological product) intended for human or animal use— (1) which— "(A) requires approval by the Secretary under section 505 or section 512, or "(B) requires licensing by the Secretary under section 351 of the Public Health Service Act or by the Secretary of Agriculture under the Act of March 4, 1913 (known as the Virus Serum Toxin Act), before it may be introduced or delivered for introduction into interstate commerce to a country, and "(2) which does not have such approval or license, which is not exempt from such sections or Act, and which is introduced or delivered for introduction into interstate commerce to a country, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug is authorized under subsection (b). "(b)(1) A drug (including a biological product) may, upon approval of an application submitted under paragraph (3), be exported if— "(A) the drug contains the same active ingredient as a— "(i) new drug—

Animals. 21 USC 382. 21 USC 355. 21 USC 360b. Commerce and trade. 42 USC 262. 21 USC 151 note.

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text: Dictionary of National Biography, 1885-1900/Pastorini, Benedict


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PUBLIC LAW 99-660—NOV. 14, 1986

"(I) which has an exemption under section 505(i), and "(II) for which approval is actively being pursued by the person who has the exemption, "(ii) biological product for human use— "(I) which has an exemption under section 505(i), and n; tiQj^ Qj. ^jjjgjj licensing of the biological product 42 USC 262. under section 351 of the Public Health Service Act is v. actively being pursued by the person who has the exemption, "(iii) biological product for animal use— "(I) for which authority heis been granted under the Virus-Serum Toxin Act for the preparation of an 21 USC 151 note. experimental drug product, and "(II) for which the licensing of the biological product under such Act is actively being pursued by the person who has the authority, or ^ "(iv) new animal drug— . *. "(I) which has an exemption under section 512(j), and 21 USC 360b. "(II) for which approval is actively being pursued by the person who has the exemption, "(B) except as provided in paragraph (2), the drug is exported to a country which is listed under paragraph (4) and in which the drug is approved and has not been withdrawn from sale, "(C) an application for the drug under section 505 or 512, section 351 of the Public Health Service Act, or the VirusSerum Toxin Act has not been disapproved by an order of the Secretary under section 505(d) or 512(d) or 351 of the Public Health Service Act or by the Secretary of Agriculture in the case of an application under the Virus-Serum Toxin Act, "(D) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under paragraph (a)(D, (a)(2)(A), (a)(3), (c), or (d) of section 501, 21 USC 351. Labeling. "(E) the outside of the shipping package is labeled with the following statement: 'This drug may be sold or offered for sale only in the following countries: ', the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection, "(F) the drug is not the subject of a notice by the Secretary or Safety. the Secretary of Agriculture of a determination that the manufacture of the drug in the United States for export to a country is contrary to the public health and safety of the United States, "(G) the requirements of subparagraphs (A) through (D) of section 801(d)(l) have been met. 21 USC 381. The Secretary shall determine that an applicant is actively pursuing the approval or licensing of a drug if the applicant has demonstrated that degree of attention and continuous directed effort as may reasonably be expected from, and are ordinarily exercised by, a person before approval or licensing of a drug, such as the preparation for and the conduct of preclinical or clinical investigations, the analysis of the results of such investigations, conferences on such investigations with government officials, and the preparation of an application of approval or licensing for the drug. "(2) The Secretary may permit the export of a drug under paragraph (1) to a country which is listed under paragraph (4) and in which the drug is not approved if the drug is exported to such 21 USC 355.

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100 STAT. 3745

country solely for the purpose of further export to a country listed in paragraph (4) in which the drug is approved. "(3)(A) Any person may apply to have a drug exported under paragraph (1). Such an application shall be filed at least 90 days before the date the applicant proposes to export the drug for which the application is submitted. Before the expiration of 10 days from the date of the submission of such an application, the Secretary shall publish a notice in the Federal Register which identifies the applicant under such application, the drug proposed to be exported under such application, and the country to which the drug is proposed to be exported. "(B) An application for the export of a drug shall— "(i) identify the drug to be exported, "(ii) list each country to which the drug is to be exported and list the persons in each such country to which the drug is to be exported, "(iii) contain a certification by the applicant that— "(I) the applicant will export the drug only to a country which is listed in paragraph (4) and in which the drug is approved unless the drug is authorized to be exported under paragraph (2) and will export only those quantities of the J drug which may reasonably be sold in each country to which it is to be exported, "(II) the drug is approved by each country to which it is to be exported unless the drug is authorized to be exported under paragraph (2) and the drug has not been withdrawn from sale in such country, "(III) the drug meets the requirements of paragraph (I)(D), "(IV) the drug will be labeled in accordance with paragraph (I)(E), and "(V) the drug meets the requirements of paragraphs (I)(C) and (IXG), "(iv) contain a certification by the holder of the exemption or authority for such drug described in paragraph (I)(A) that the holder will actively pursue the approval or licensing of the drug, "(v) identify the exemption or authority for an experimental drug product in effect for such drug under the laws referred to in paragraph (I)(A), "(vi) identify the establishments in which the drug is manufactured, and "(vii) include a written agreement from each importer to whom the drug is to be exported from the United States that such importer will not export the drug to a country which is not . listed under paragraph (4) and will provide notice to the applicant of any knowledge of an export of the drug to such a. country by any person and will maintain records of the drug wholesale distributors to which the drug is sold. "(C)(i) Before the expiration of 30 days after the date an application is submitted to the Secretary, the Secretary shall review the application to determine if the application meets the requirements of clauses (i), (ii), (iv), (v), (vi), and (vii) of subparagraph (B) and contains the certifications described in clauses (iii) (other than the certification required by clause (iiiXID) and (iv). If the Secretary determines that the application meets such requirements and contains such certifications the Secretary shall conditionally approve the application. An application which is so conditionally approved

Federal Register, publication.

Contracts. Records.

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text: The Bobbsey Twins at the Seashore/Chapter 18


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PUBLIC LAW 99-660—NOV. 14, 1986

shall be finally approved within 5 days of the submission of the certification required by clause (iiiXII). "(ii) If the Secretary proposes to disapprove an application, the Secretary shall provide the applicant with a written statement specifying— "(I) the deficiencies which the applicant must correct in order to enable the Secretary to approve the application, and ' "(II) that the applicant has 60 days after receiving the statement to correct such deficiencies. "(D) If the holder of an application approved under subparagraph (C) for the export of a drug intends to export such drug to a country listed in paragraph (4) which is not listed in such application, such holder shall submit an amendment to such application to the Secretary not later than 30 days before the date of the proposed export to such country identifying the country to which the holder intends to export such drug and containing information sufficient to show that the drug is approved by such country and has not been withdrawn from sale in such country. The Secretary shall approve or disapprove the export of such drug to such country within 15 days of the receipt of the notice required by this subparagraph. Recipient "(4)(A) The countries to which a drug may be exported under countries. paragraph (1) are— "(i) Australia, ^ "(ii) Austria,

.ti.s "(iii) Belgium, '"(iv) Canada, "(vi) Federal Republic of Germany, i^"s: "(vii) Finland, "(viii) France, ' "(ix) Iceland, /. "(x) Ireland, ^ ^ "(xi)Italy, ' ' "(xii) Japan, ' ' '"'• "(xiii) Luxembourg, "(xiv) The Netherlands, "(xv) New Zealand, "(xvi) Norway, n "(xvii) Portugal, ., "(xviii) Spain, . » " ^ "(xix) Sweden,, '" *^ "(xx) Switzerlgmd, and "(xxi) The United Kingdom, "(B) Changes in the list contained in subparagraph (A) shall be based on the following criteria: Safety. "(i) Statutory or r ^ u l a to r y requirements which require the review of drugs for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs.
 * ,''"(v) Denmark,

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text: Dictionary of National Biography, 1885-1900/Pastorius, Francis Daniel


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100 STAT. 3747

,,,

"(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength, "(iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective, "(iv) Statutory or regulatory requirements that the labeling and promotion of drugs must be in accordance with the approval of the drug. "(c)(1) The holder of an approved application under subsection Qi) authorizing the export of a drug shall report to the Secretary— "(A) any withdrawal of an approval of the drug by any country to which it has been exported, "(B) any withdrawal of the drug from sale in any such country, "(C) the withdrawal of an application by the holder under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act, and "(D) the receipt of any credible information indicating that the drug is being or may have been exported from a country listed under subsection (b)(4) to a country which is not listed under such subsection. The reporting of an event described in subparagraph (A), (B), or (C) shall be made within 15 days of the occurrence of the event and the reporting of the receipt of information under subparagraph (D) shall be made within 15 days of the receipt of such information. "(2) The holder of an approved application under subsection (b) authorizing the export of a drug shall report annually to the Secretary after the date of the approval of the application of the actions taken by the holder in pursuit of the approval of such drug during the yeai reported on. Not later than 90 days from the date of the receipt of a report under this paragraph the Secretary shall determine if the holder is actively pursuing the approval of such drug. "(d) A drug authorized to be exported to a country under an application approved under subsection (b) may not be exported to such country if— "(1) an approval of such drug is withdrawn by such country, "(2) the drug is withdrawn from sale in such country, ^^ "(3) the Secretary issues an order refusing to approve an application of the holder of such application under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act, or "(4) an application for such drug under such section or Act is withdrawn or if an exemption for such drug under section 505(i) or 512(j) or the authority granted for such drug to prepare an experimental drug product under the Virus-Serum Toxin Act is withdrawn and no application for approval of such drug has been submitted under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act. "(e)(1) If the Secretary determines that— "(A) a drug for which an application was approved under subsection (b) no longer complies with subparagraphs (A), (D), (E), and (G) of paragraph (1) of such subsection or with paragraph (2) of such subsection or the holder of such application has not made the reports required by subsection (c), or

Safety.

Labeling. Marketing. Reports.

21 USC 355, 3606; 42 USC 262. 21 USC 151 note.

Reports.

Reports.

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 100 STAT. 3748 Safety.

..5- ,,

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PUBLIC LAW 99-660—NOV. 14, 1986

"(B) the manufacture of a drug in the United States for export is contrary to the public health and safety of the United States and an application for the export of such drug has been approved under subsection (b), then before taking action against the holder of an application for which a determination was made under subparagraph (A) or (B), the Secretary shall notify the holder in writing of the determination and provide the holder 30 days to take such action as may be required so that the Secretary would be unable to make such determination. When the Secretary takes action against such holder because of such a determination, the Secretary shall provide the holder a written statement specifying the reasons for such determination and provide the person, on request, an opportunity for an informal hearing with respect to such determination. "(2) If the Secretary determines that the approval of a drug is not being actively pursued as required by subsection (b)(1)(A), the Secretary shall give the holder of the application authorizing the export of such drug 60 days to assure that actions are taken to actively pursue such approval. During the 60-day period the Secretary shall give the holder an opportunity for an informal hearing on the determination of the Secretary. If upon the expiration of such 60-day period the Secretary determines that approval of such drug is not being actively pursued, the Secretary shall prohibit the export of such drug. "(3)(A) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that— "(i) the holder of an approved application under subsection (b) I is exporting a drug from the United States to an importer, "(ii) such importer is exporting the drug to a country which is s. not listed under subsection (b)(4), and "(iii) such export presents an imminent hazard to the public health in such country, the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United States prompt notice of the determination, and afford such person an opportunity for an expedited hearing. "(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court. "(4)(A) If the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that the holder of an approved application under subsection Ob) is exporting a drug to a country which is not listed under subsection (b)(4) and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing. "(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court. "(5) If the Secretary receives credible evidence that the holder of an application approved under subsection (b) is exporting a drug to a country which is not listed under subsection (b)(4), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an oppor-

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text: Dictionary of National Biography, 1885-1900/Patch, Richard


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 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3749

tunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary shall prohibit the export of such drug to such country if the Secretary determines that the holder of the application is exporting the drug to a country which is not listed under subsection (b)(4). "(6) If the Secretary receives credible evidence that an importer is exporting a drug to a country which is not listed under subsection (b)(4), the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional. "(fKl) A drug (including a biological product) which is to be used in the prevention or treatment of a tropical disease may, upon approval of an application submitted under paragraph (2), be exported if— "(A) the Secretary finds, based on credible scientific evidence, including clinical investigations, that the drug is safe and effec'• tive in the country to which it is to be exported in the prevention or treatment of a tropical disease in such country, "(B) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under paragraph (a)(D, (a)(2)(A), (a)(3), (c), or (d) of section 501, "(C) the outside of the shipping package is labeled with the ^i^ following statement: 'This drug may be sold or offered for sale only in the following countries: ', the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection, "(D) the drug is not the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the manufacture of the drug in the United States for export to a country is contrary to the public health and safety of the United States, and "(E) the requirements of subparagraphs (A) through (D) of section 801(d)(l) have been met. "(2) Any person may apply to have a drug exported under paragraph (1). The application shall— "(A) describe the drug to be exported, "(B) list each country to which the drug is to be exported, "(C) contain a certification by the applicant that the drug will not be exported to a country for which the Secretary cannot make a finding described in paragraph (I)(A), "(D) identify the establishments in which the drug is manufactured, and "(E) demonstrate to the Secretary that the drug meets the requirements of paragraph (1). "(3) The holder of an approved application for the export of a drug under this subsection shall report to the Secretary— "(A) the receipt of any information indicating that the drug is being or may have been exported from a country for which the Secretary made a finding under paragraph (I)(A) to a country for which the Secretary cannot make such a finding, and

Reports,

Safety.

21 USC 351. Labeling.

Safety.

21 USC 381.

Reports.

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PUBLIC LAW 99-660—NOV. 14, 1986

"(B) the receipt of any information indicating any adverse reactions to such drug. . "(4)(A) If the Secretary determines that— "(i) a drug for which an appHcation is approved under paragraph (2) does not continue to meet the requirements of paragraph (1), "(ii) the holder of such application has not made the report required by paragraph (3), or "(iii) the manufacture of such drug in the United States for export is contrary to the public health and safety of the United States and an application for the export of such drug has been approved under paragraph (2), then before taking action against the holder of an application for which a determination was made under clause (i), (ii), or (iii), the Secretary shall notify the holder in writing of the determination and provide the holder 30 days to take such action as may be required so that the Secretary would be unable to make such determination. When the Secretary takes action against such holder because of such a determination, the Secretary shall provide the holder a written statement specifying the reasons for such determination and provide the person, on request, an opportunity for an informal hearing with respect to such determination. "(B) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that— "(i) the holder of an approved application under paragraph (2) is exporting a drug from the United States to an importer, "(ii) such importer is exporting the drug to a country for which the Secretary cannot make a finding under paragraph dXA),and "(iii) such export presents an imminent hazard to the public health in such country, the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United States prompt notice of the determination, and afford such person an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary. "(C) If the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that the holder of an approved application under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (I)(A), and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary. "(D) If the Secretary receives credible evidence that the holder of an application approved under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (I)(A), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an opportunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary

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100 STAT. 3751

shall prohibit the export of such drug to such country if the Secretary determines the holder is exporting the drug to a country for which the Secretary cannot make a finding under paragraph (I)(A). "(E) If the Secretary receives credible evidence that an importer is Reports. exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional. "(g) For purposes of this section— "(1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Virus-Serum Toxin Act be considered to be a reference to the Secretary of Agriculture, and "(2) a reference in paragraph (3), (4), (5), or (6) of subsection (e) and in subparagraph (B), (C), (D), or (E) of subsection (f)(4) to the holder of an application shall be considered a reference to any person which is under common control with holder, is controlled by the holder, controls the holder, is owned by the holder, or owns the holder.". SEC. 103. ENFORCEMENT.

For the fines authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act, see section 3623 of title 18, United States Code, for the period ending October 31, 1986, and sections 3559 and 3571 of such title for the period beginning November 1, 1986.

21 USC 333 note. 21 USC 333.

SEC. 104. TROPICAL DISEASES.

Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following: "(c) The Secretary may conduct biomedical research, directly or through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States.".

Research and development. Grants. Contracts.

SEC. 105. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.

(a) AMENDMENT.—Section 351 of the Public Health Service Act (42 U.S.C 262) is amended by adding at the end the following: Post, p. 3783. "(h)(1)(A) A partially processed biological product which is not in a Labeling. form applicable to the prevention, treatment, or cure of diseases or injuries of man, which is not intended for sale in the United States, and which is intended for further manufacture into final dosage form outside the United States in a country listed under section 802(b)(A) of the Federal Food, Drug, and Cosmetic Act may, upon Ante, p. 3743. approval of an application meeting the requirements of subparagraph (B), be exported to a country listed under section 802(b)(4) of the Federal Food, Drug, and Cosmetic Act. The Secretary may not approve an application to export such a product unless the Secretary determines that the product is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and the outside of the shipping package is labeled with the

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PUBLIC LAW 99-660—NOV. 14, 1986

following statement: 'This product may be sold or offered for sale only in the following countries: ', the blank space being filled with a list of the countries to which export of the drug is authorized. "(B) An application for the export of a partially processed biological product shall— "(i) describe the partially processed biological product to be exported, "(ii) list each country to which the product is to be exported, "(iii) contain a certification by the applicant that the product will not be exported to a country not listed under clause (ii), "(iv) identify the establishments in which the product is manufactured, and "(v) contain a certification by the applicant that the final product to be developed from the partially processed product is approved in the country to which it is to be exported or approval of the final product is being sought in such country. "(2) A product described in paragraph (1) is not subject to licensure under this section. "(3) If the Secretary determines that prohibiting the export of a product described in paragraph (1) is necessary for protection of the public health in the United States or the country to which it is to be exported, the Secretary may not approve an application under paragraph (1) for the export of such product.". (b) EFFECTIVE DATE.—Paragraph (1) of section 351(h) of the Public 42 USC 262 note. Health Service Act as added by subsection (a) shall take effect upon the expiration of 90 days after the date of the enactment of this Act. National Commission to Prevent Infant Mortality Act of 1986. 42 USC 289g note. 42 USC 289g note.

42 USC 289g note.

TITLE II—NATIONAL COMMISSION TO PREVENT INFANT MORTALITY SEC. 201. SHORT TITLE.

This title may be cited as the "National Commission to Prevent Infant MortaHty Act of 1986". SEC. 202. DEFINITION.

For the purposes of this title, the term "infant mortality" refers to the number of infants born alive but who die before their first birthday. SEC. 203. ESTABLISHMENT OF A NATIONAL COMMISSION. ^ (a) E^ABLiSHMENT.—There is established the National Commission to Prevent Infant Mortality (hereinafter referred to as the "Commission"). (b) COMPOSITION.—The Commission shall be composed of fifteen members, as follows: (1) Two members of the Senate, one to be selected by the majority leader of the Senate, the other to be selected by the minority leader of the Senate. (2) Two members of the House, one to be selected by the Speaker of the House, the other to be selected by the minority leader of the House. (3) Three representatives of State government shall be jointly selected by the majority leader of the Senate and the Speaker of the House. One shall be a Governor; one shall be a chief State official responsible for administering the State medicaid pro-

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gram; and one shall be the chief State official responsible for administering the State maternal and child health programs. (4) The Secretary of Health and Human Services shall be a member. (5) The Comptroller General of the United States shall be a member. (6) Six at large members, with demonstrated expertise in maternal and child health, including representatives of health care consumer and provider organizations, shall be jointly selected by the majority leader of the Senate and the Speaker of the House. (c) CHAIRMAN AND VICE CHAIRMAN.—The Commission shall select a Chairperson and Vice Chairperson from among its members. (d) QUORUM.—Eight members of the Commission shall constitute a quorum, but a lesser number may hold hearings. (e) MEETINGS.—The Commission shall meet at the call of the Chairperson. (f) VACANCIES.—Members shall be appointed for the life of the Commission. Any vacancy in the Commission shall not affect its powers, but shall be filled in the same manner as the original appointment.

'

SEC. 204. DUTIES OF THE COMMISSION.

42 USC 285g '-

(a) DUTIES.—The Commission shall: (1) Identify and examine comprehensively Federal, State, local, and private resources which impact infant mortality, including but not limited to— (A) the effectiveness and adequacy of programs such as the Supplemental Feeding Program for Women, Infants, and Children; the Maternal and Child Health Block Grant; Community Health Centers; prepregnancy services and other programs that increase access to prenatal and postnatal education, care, and nutrition; (B) the effectiveness of current Federal and State policies under the Medicaid Program to ensure adequate access to prenatal and post-natal care for low-income pregnant women, mothers, and infants up to age one; (C) the role of income maintenance and other programs that impact infant mortality such as Aid to Families with Dependent Children and Federal housing subsidies; (D) the adequacy of current Federal and State efforts to enable an appropriate distribution of properly trained health care professionals to provide comprehensive maternal and child health services; (E) the adequacy of private health care financing systems and mechanisms to enable pregnant women and infants to receive comprehensive health care; and (F) the adequacy of the national biostatistics registration ^ system with respect to the collection and reporting of infant health statistics. (2) Identify current financial, intergovernmental, and within the Federal Government, interagency barriers to the health care needed to prevent high infant mortality. (3) Review recommendations made in recent regional and national reports that promote the health status of childbearing women and their infants and carry forward such recommendations as deemed appropriate.

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PUBLIC LAW 99-660—NOV. 14, 1986 (4) Hold hearings, in accordance with section 205(a), in areas of the United States with high infant mortality rates. (b) RECOMMENDATIONS.—The Q)mmission shall— (1) recommend a national policy designed to reduce and prevent infant mortality, including recommendations concerning populations at risk of high infant death rates and recommendations concerning appropriate roles for the Federal Government, States, local governments, and private sector; (2) recommend to the Congress and the President the specific changes needed within Federal laws and Federal programs to achieve an effective Federal role in preventing infant mortality, including the programs specified in subparagraphs (A) and (B) of subsection (a)(D; (3) recommend to the Congress and the President the specific changes needed to improve the national vital statistics registration system with respect to infant death statistics; and (4) present such recommendations to the President, the Committee on Energy and Commerce of the House of Representatives, and the Committees on Finance and Governmental Affairs of the Senate no later than one year after enactment of this Act.

42 USC 285g

SEC. 205. POWERS OF THE COMMISSION.

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i-

(a) HEARINGS.—The Commission, or at its direction, any subcommittee or member thereof, may for the purpose of carrying out the provisions of this title, hold such hearings, sit and act at such times and places, take such testimony, receive such evidence and administer such oaths, as the Commission or such subcommittee or member may deem advisable. Any member of the Commission may administer oaths or affirmations to witnesses appearing before the Commission, subcommittee, or member thereof. Qo) INFORMATION.—The Commission may secure directly from any Federal department or agency such information as may be necessary to enable the Commission to carry out this title. Upon request of the Chairman of the Commission, the head of such department or agency shall furnish such information to the Commission. (c) CONTRACTS.—To carry out this title, the Commission may entei into such contracts and other arrangements to such extent or in such amounts as are provided in appropriation Acts, and without regard to the provisions of section 3709 of the Revised Statutes (41 U.S.C. 5). Contracts and other arrangements may be entered into under this subsection with or without consideration or bond. (d) APPLICABILITY OF FEDERAL ADVISORY COMMITTEE ACT.—The

5 USC app.

provisions of the Federal Advisory Committee Act shall not apply to the Commission.

42 USC 285g

SEC. 206. COMMISSION STAFF.

(a) EXECUTIVE DIRECTOR.—The Chairperson and Vice Chairperson of the Commission shall appoint an executive director. The employment of such executive director shall be subject to confirmation by the Commission. (b) OTHER PERSONNEL.—The Commission may appoint and terminate the executive director selected under subsection (a) and such other personnel as it considers appropriate to assist in the performance of its duties under this title, without regard to the provisions of title 5, United States Code, governing appointments in the competi-

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100 STAT. 3755

tive service, and may pay such executive director and other personnel without regard to the provisions of chapter 51 and subchapter 111 of chapter 53 of such title relating to classification and General Schedule pay rates, except that the rate of pay for such executive director and other personnel may not exceed the rate payable for GS-18 of the General Schedule under section 5332 of such title.

5 USC 5101 et seq. 5 USC 5331.

(c) APPLICABILITY OF OTHER FEDERAL LAWS.—Service of an individ-

ual as a member of the Commission or employment of an individual by the Commission on a part-time or full-time basis and with or without compensation shall not be considered as service or employment bringing such individual within the provisions of any Federal law relating to conflicts of interest or otherwise imposing restrictions, requirements, or penalties in relation to the employment of persons, the performance of services, or the payment or receipt of compensation in connection with claims, proceedings, or matters involving the United States. Service as a member of the Commission or as an employee of the Commission, shall not be considered service in an appointive or elective position in the Government for purposes of section 8344 of title 5, United States Code, or comparable provisions of Federal law. (d) EXPERTS AND CONSULTANTS.—Subject to such rules as may be prescribed by the Commission, the Chairman of the Commission may procure temporary and intermittent services under section 3109 of title 5, United States Code, at rates for individuals not to exceed the daily rate payable for GS-18 of the General Schedule under section 5332 of such title. SEC. 207. SUNSHINE PROVISION.

The Commission shall establish procedures to ensure its proceedings are open to the public to the maximum extent practicable. SEC. 208. TERMINATION OF THE COMMISSION.

Ninety days after the Commission submits its recommendations as required by section 204(b)(4) the Commission shall terminate. SEC. 209. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated to the Commission such sums as may be necessary. Amounts appropriated under this section shall remain available until the day on which the Commission terminates under section 208.

TITLE III—VACCINE COMPENSATION SEC. 301. SHORT TITLE.

This title may be cited as the "National Childhood Vaccine Injury Act of 1986". PART A—VACCINES SEC. 311. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

(a) NEW TITLE.—The Public Health Service Act is amended by redesignating title XXI as title XXIII, by redesignating sections 2101 through 2116 as sections 2301 through 2316, respectively, and by inserting after title XX the following new title:

42 USC 285g note.

42 USC 285g note.

42 USC 285g note.

National Childhood Vaccine Injury Act of 1986. 42 USC 201.

42 USC 300aa et seq., 300cc et seq.

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PUBLIC LAW 99-660—NOV. 14, 1986 "TITLE XXI—VACCINES

.

'Subtitle 1—National Vaccine Program ESTABLISHMENT 42 USC 300aa-l.

"SEC. 2101. The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a Director selected by the Secretary. "PROGRAM RESPONSIBILITIES

42 USC 300aa-2.

"SEC. 2102. (a) The Director of the Program shall have the following responsibilities: "(1) VACCINE RESEARCH.—The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for research carried out in or through the National Institutes of Health, the Centers for Disease Control, the Office of Biologies Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development on means to induce human immunity against naturally occurring infectious diseases and to prevent adverse reactions to vaccines. "(2) VACCINE DEVELOPMENT.—The Director of the Program

shall, through the plan issued under section 2103, coordinate and provide direction for activities carried out in or through the National Institutes of Health, the Office of Biologies Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development to develop the techniques needed to produce safe and effective vaccines. "(3) SAFETY AND EFFICACY TESTING OF VACCINES.—The Director

of the Program shall, through the plan issued under section 2103, coordinate and provide direction for safety and efficacy testing of vaccines carried out in or through the National Institutes of Health, the Centers for Disease Control, the Office of Biologies Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development. "(4) LICENSING OF VACCINE MANUFACTURERS AND VACCINES.—

42 USC 263a.

The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for the allocation of resources in the implementation of the licensing program under section 353. "(5) PRODUCTION AND PROCUREMENT OF VACCINES.—The Direc-

,.ft-

tor of the Program shall, through the plan issued under section 2103, ensure that the governmental and non-governmental production and procurement of safe and effective vaccines by the Public Health Service, the Department of Defense, and the Agency for International Development meet the needs of the United States population and fulfill commitments of the United States to prevent human infectious diseases in other countries. "(6) DISTRIBUTION AND USE OF VACCINES.—The Director of the

Program shall, through the plan issued under section 2103, coordinate and provide direction to the Centers for Disease

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Control and assistance to States, localities, and health practitioners in the distribution and use of vaccines, including efforts to encourage public acceptance of immunizations and to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines. "(7) EVALUATING THE NEED FOR AND THE EFFECTIVENESS AND ADVERSE EFFECTS OF VACCINES AND IMMUNIZATION ACTIVITIES.—

The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the National Institutes of Health, the Centers for Disease Control, the Office of Biologies Research and Review of the Food and Drug Administration, the National Center for Health Statistics, the National Center for Health Services Research and Health Care Technology Assessment, and the Health Care Financing Administration in monitoring the need for and the effectiveness and adverse effects of vaccines and immunization activities. "(8) COORDINATING GOVERNMENTAL AND NON-GOVERNMENTAL

ACTIVITIES.—The Director of the Program shall, through the plan issued under section 2103, provide for the exchange of information between Federal agencies involved in the implementation of the Program and non-governmental entities engaged in the development and production of vaccines and in vaccine research and encourage the investment of non-governmental resources complementary to the governmental activities under the Program. "(9) FUNDING OF FEDERAL AGENCIES.—The Director of

the

Program shall make available to Federal agencies involved in the implementation of the plan issued under section 2103 funds appropriated under section 2106 to supplement the funds otherwise available to such agencies for activities under the plan. "(h) In carrying out subsection (a) and in preparing the plan under section 2103, the Director shall consult with all Federal agencies involved in research on and development, testing, licensing, production, procurement, distribution, and use of vaccines. PLAN

"SEC. 2103. The Director of the Program shall prepare and issue a plan for the implementation of the responsibilities of the Director under section 2102. The plan shall establish priorities in research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines, describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their vaccine functions in consultation and coordination with the Program and in conformity with such priorities. The first plan under this section shall be prepared not later than January 1, 1987, and shall be revised not later than January 1 of each succeeding year.

42 USC 300aa-3.

REPORT

"SEC. 2104. The Director shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate not later than January 1, 1988, and annually thereafter on the implementation of the Program and the plan prepared under section 2103.

42 USC 300aa-4.

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100 STAT. 3758

NATIONAL VACCINE ADVISORY COMMITTEE

42 USC 300aa-5.

"SEC. 2105. (a) There is established the National Vaccine Advisory Committee. The members of the Committee shall be appointed by the Director of the Program, in consultation with the National Academy of Sciences, from among individuals who are e n g ^ e d in vaccine research or the manufacture of vaccines or who are physicians, members of parent organizations concerned with immunizations, or representatives of State or local health agencies or public health organizations. "(b) The Committee shall— "(1) study and recommend ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States, "(2) recommend research priorities and other measures the Director of the Program should take to enhance the safety and efficacy of vaccines, "(3) advise the Director of the Program in the implementation of sections 2102, 2103, and 2104, and "(4) identify annually for the Director of the Program the most important areas of government and non-government cooperation that should be considered in implementing sections 2102, 2103, and 2104. H*5^

42 USC 300aa-6.

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AUTHORIZATIONS

r

"SEC. 2106. (a) To carry out this subtitle other than section 2102(9) there are authorized to be appropriated $2,000,000 for fiscal year 1987, $2,500,000 for fiscal year 1988, $3,000,000 for fiscal year 1989, $3,500,000 for fiscal year 1990, $4,000,000 for fiscal year 1991. "(b) To carry out section 2102(9) there are authorized to be appropriated $20,000,000 for fiscal year 1987, $22,500,000 for fiscal year 1988, $25,000,000 for fiscal year 1989, $27,500,000 for fiscal year 1990, $30,000,000 for fiscal year 199L ,. .^ "Subtitle 2—National Vaccine Injury Compensation Program "PART A—PROGRAM REQUIREMENTS "ESTABLISHMENT OP PROGRAM

42 USC 300aa-10.

2110. (a) PROGRAM ESTABLISHED.—There is established the National Vaccine Injury Compensation Program to be administered by the Secretary under which compensation may be paid for a vaccine-related injury or death. "(b) ATTORNEY'S OBLIGATION.—It shall be the ethical obligation of any attorney who is consulted by an individual with respect to a vaccine-related injury or death to advise such individual that compensation may be available under the program for such injury or death. "SEC.

"PETITIONS FOR COMPENSATION

42 USC 300aa-ll.

"SEC. 2111. (a) GENERAL RULE.—

"(1) A proceeding for compensation under the Program for a vaccine-related injury or death shall be initiated by service upon the Secretary and the filing of a petition with the United States district court for the district in which the petitioner resides or in which the injury or death occurred.

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100 STAT. 3759

"(2)(A) No person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this subtitle, and no such court may award damages in an amount greater than $1,000 in a civil action for damages for such a vaccine-related injury or death, unless— "(i) a petition has been filed, in accordance with section 2116, under subsection Oa) for compensation under the Program for such injury or death, "(ii) a district court of the United States has issued a Ckjurts, U.S. judgment under section 2112 on such petition, and "(iii) such person elects under section 2121(a) to file such an action. "(B) If a civil action which is barred under subparagraph (A) Courts, U.S. is filed in a State or Federal court, the court shall dismiss the action. If a petition is filed under this section with respect to the injury or death for which such civil action was brought, the date such dismissed action was filed shall, for purposes of the limitations of actions prescribed by section 2116, be considered the date the petition was filed if the petition was filed within one year of the date of the dismissal of the civil action. "(3) No vaccine manufacturer may be made a party to a civil action (other than a civil action which may be brought under paragraph (2)) for damages for a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this subtitle. "(4) If in a civil action brought against a vaccine manufacturer before the effective date of this subtitle damages were denied for a vaccine-related injury or death or if such civil action was dismissed with prejudice, the person who brought such action may file a petition under subsection (b) for such injury or death. "(5)(A) A plaintiff who on the effective date of this subtitle has pending a civil action for damages for a vaccine-related injury or death may, at any time within 2 years after the effective date of this title or before judgment, whichever occurs first, elect to withdraw such action without prejudice and file a petition under subsection (b) for such injury or death. "(B) If a plaintiff who on the effective date of this subtitle had pending a civil action for damages for a vaccine-related injury or death does not withdraw the action under subparagraph (A), such person may not file a petition under subsection (b) for such injury or death. "(6) If a person brings a civil action after the effective date of this subtitle for damages for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this subtitle, such person may not file a petition under subsection (b) for such injury or death. "(7) If in a civil action brought against a vaccine manufacturer for a vaccine-related injury or death damages are awarded under a judgment of a court or a settlement of such action, the person who brought such action may not file a petition under subsection (b) for such injury or death.
 * (b) PETITIONERS.—

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PUBLIC LAW 99-660—NOV. 14, 1986

"(I)(A) Except as provided in subparagraph (B), any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine set forth in the Vaccine Injury Table may file a petition for compensation under the Program. "(B) No person may file a petition for a vaccine-related injury or death associated with a vaccine administered before the effective date of this subtitle if compensation has been paid under this subtitle for 3500 petitions for such injuries or deaths. "(2) Only one petition may be filed with respect to each administration of a vaccine. "(c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall contain— "(1) an affidavit, and supporting documentation, demonstrating that the person who suffered such injury or who died— "(A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a vaccine, contracted polio, directly or indirectly, from another person who received an oral polio vaccine, "(B)(i) if such person received a vaccine set forth in the Vaccine Injury Table— "(I) received the vaccine in the United States or in its trust territories, "(11) received the vaccine outside the United States or
 * 'i\

a trust territory and at the time of the vaccination such ,j person was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the United States or a dependent of such a citizen, or "(HI) received the vaccine outside the United States or a trust territory and the vaccine was manufactured by a vaccine manufacturer located in the United States and such person returned to the United States not later than 6 months after the date of the vaccination, "(ii) if such person did not receive such a vaccine but contracted polio from another person who received an oral polio vaccine, was a citizen of the United States or a dependent of such a citizen, "(C)(i) sustained, or had significantly aggravated, any o, • illness, disability, injury, or condition set forth in the Vaccine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the administration of such vaccine, and the first symptom or manifestation of the onset or of the significant aggravation of any such illness, disability, injury, or condition or the death occurred within the time period after vaccine administration set forth in the Vaccine Lijury Table, or "(iiXD sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the <x" Vaccine Injury Table but which was caused by a vaccine r referred to in subparagraph (A), or "(II) sustained, or had significantly aggravated, any illi-ljjfj ness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur

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Page:United States Statutes at Large Volume 100 Part 5.djvu/287

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3761

within the time period set forth in the Table but which was caused by a vaccine referred to in subparagraph (A), "(D)(i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 1 year after the administration of the vaccine, (ii) incurred unreimbursable expenses due in whole or in part to such illness, disability, injury, or condition in an amount greater than $1,000, or (iii) died from the administration of the vaccine, and "(E) has not previously collected an award or settlement of a civil action for damages for such vaccine-related injury or death, "(2) all available relevant medical records (including autopsy reports, if any) relating to the person who suffered such injury or who died from the administration of the vaccine and an identification of any unavailable records known to the petitioner and the reasons for their unavailability, and "(3) appropriate assessments, evaluations, and prognoses and such other records and documents as are reasonably necessary for the determination of the amount of compensation to be paid to, or on behalf of, the person who suffered such injury or who died from the administration of the vaccine. COURT JURISDICTION "SEC. 2112. (a) GENERAL RULE.—The district courts of the United

States shall have jurisdiction (1) over proceedings to determine if a petitioner under section 2111 is entitled to compensation under the Program and the amount of such compensation, and (2) to issue and enforce such orders as the courts deem necessary to assure the prompt payment of any compensation awarded.

42 USC

300aa-12.

"(b) PARTIES.—

"(1) The Secretary shall be named as the respondent in all proceedings brought by the filing of a petition under section 2111(b). Except as provided in paragraph (2), no other person may intervene in any such proceeding. "(2) Within 30 days after the Secretary receives service of any Federal petition filed under section 2111 the Secretary shall publish Register, notice of such petition in the Federal Register. The special publication. master designated with respect to such petition under subsection (c) shall afford all interested persons an opportunity to submit relevant, written information— "(A) relating to the existence of the evidence described in section 2113(a)(1)(B), or "(B) relating to any allegation in a petition with respect to the matters described in section 2111(c)(l)(C)(ii). "(c) SPECIAL MASTERS.—

"(1) Following receipt of a petition under subsection (a), the district court of the United States in which the petition is filed shall designate a special master to carry out the functions authorized by paragraph (2). "(2) A special master shall serve as an adjunct to the court and may— "(A) require such evidence as may be appropriate for the preparation of proposed findings of fact and conclusions of law with respect to whether compensation is to be provided

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Page:United States Statutes at Large Volume 100 Part 5.djvu/288

 100 STAT. 3762

PUBLIC LAW 99-660—NOV. 14, 1986 under the Program and the amount of any such compensation, "(B) require the submission of such information as may be reasonable and necessary to determine if the petitioner is entitled to compensation, "(C) require the testimony of any person and the production of any document as may be reasonable and necessary to determine if the petitioner is entitled to compensation, "(D) conduct such hearings as may be appropriate, and "(E) prepare and submit to the court proposed findings of fact and conclusions of law. Information submitted to a special master in a proceeding on a petition may not be disclosed to a person who is not a party to the proceeding without the express, written consent of the person who submitted the information. There may be no discovery in a proceeding on a petition other than the discovery required under this paragraph. "(d) ACTION BY THE Ck>uRT,—

Records.

"(1) Upon objection by the petitioner or respondent to the proposed findings of fact or conclusions of law prepared by the special master or upon the court's own motion, the court shall undertake a review of the record of the proceedings and may thereafter make a de novo determination of any matter and issue its judgment accordingly, including findings of fact and conclusions of law, or remand for further proceedings. "(2) If no objection is filed under paragraph (1) or if the court does not choose to review the proceeding, the court shall adopt the proposed findings of fact and conclusions of law of the special master as its own and render judgment thereon. "(3) The court shall render its judgment on any petition filed under the Program as expeditiously as practicable but not later than 365 days after the date on which the petition was filed. "(e) ADMINISTRATION OF AWARD.—The Program shall administer the payments of such compensation. The Program shall audit the payments of compensation under a judgment. A petitioner awarded compensation shall notify the Program of any changes which significantly affect the compensation to be paid. "(0 REVISION OF AWARD.—

"(1) If the court issues a judgment awarding to a petitioner compensation described in section 2115(a)(l)(A) for unreimbursable expenses and the compensation is insufficient to meet such expenses, such petitioner may petition the court to (A) review such award, and (B) increase the award to make it sufficient to meet such expenses or amend the periodic payment schedule established under section 2115, or both. "(2) If an audit conducted under subsection (e) discloses the improper use of compensation awarded under a judgment or the termination of a need for an item of compensation, the Program shall petition the court which awarded the compensation to make an appropriate revision in the compensation. "(g) APPEALS.—The findings of fact and conclusions of law of a district court of the United States on a petition shall be final determinations of the matters involved, except that the Secretary or any petitioner aggrieved by the findings or conclusions of the court may obtain review of the judgment of the court in the United States court of appeals for the circuit in which the court is located upon petition filed with such court of appeals.

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text: Dictionary of National Biography, 1885-1900/Pater, Walter Horatio


text:
Page:United States Statutes at Large Volume 100 Part 5.djvu/289

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3763

DETERMINATION OF ELIGIBILITY AND COMPENSATION 'SEC. 2113. (a) GENERAL RULE.—

Courts, U.S. Records.

"(1) Compensation shall be awarded under the Program to a 42 USC petitioner if the court finds on the record as a whole— 300aa-13. "(A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 2111(c)(1), and "(B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition. The court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion. "(2) For purposes of paragraph (1), the term 'factors unrelated to the administration of the vaccine'— "(A) does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and "(B) may, as documented by the petitioner's evidence or other material in the record, include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner's illness, disability, injury, condition, or death. '(b) MATTERS TO B E CONSIDERED.—

"(1) In determining whether to award compensation to a Courts, U.S. petitioner under the Program, the court shall consider, in addi- Records. tion to all other relevant medical and scientific evidence contained in the record— "(A) any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death, and "(B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions. Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the court. In evaluating the weight to be afforded to any such diagnosis, conclusion, judgment, test result, report, or summary, the court shall consider the entire record and the course of the injury, disability, illness, or condition until the date of the judgment of the court. "(2) The court may find the first symptom or manifestation of onset or significant aggravation of an injury, disability, illness, condition, or death described in a petition occurred within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period. Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset or significant aggravation of the injury, disability, illness, condi-

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Page:United States Statutes at Large Volume 100 Part 5.djvu/290

 100 STAT. 3764

' '^

PUBLIC LAW 99-660—NOV. 14, 1986

tion, or death described in the petition did in fact occur within the time period described in the Vaccine Injury Table. "(c) RECORD DEFINED.—For purposes of this section, the term 'record' means the record established by a distict court of the United States in a proceeding on a petition filed under section 2111. i^w, !v

42 USC 300aa-14.

tf"

" V A C C I N E INJURY TABLE

H

2114. (a) INITIAL TABLE.—The following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program: "SEC.

"VACCINE INJURY TABLE I.

DTP; P; DTP/Polio Combination; or , , Any Other Vaccine Containing Whole Cell Pertussis Bacteria, •jc 2' Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s). Illness, disability, injury, or condi- Time period for first symptom or C = tion covered: manifestation of onset or of significant aggravation after vaccine administration: A. Anaphylaxis or anaphylactic shock 24 hours B. Encephalopathy (or encephalitis)... 3 days ••'- '• C. Shock-collapse or hypotonic-by, ,,. ^ *' poresponsive collapse 3 days •',t'^ -' " jp' '. ^ D Residual seizure disorder in ac' . ^., '•" cordance with subsection (c)(2) 3 days E. Any acute complication or seque" '• la (including death) of an illness, ^, »' ^. disability, injury, or condition re,;;•• ferred to above which illness, disability, injury, or condition arose within the time period prescribed... Not applicable n. Measles, mumps, rubella, or any j-^. . i. vaccine containing any of the ,^, foregoing as a component; DT; Td; ! or Tetanus Toxoid. .-- . ', A. Anaphylaxis or anaphylactic shock 24 hours B. Encephalopathy (or encephalitis)... 15 days (for mumps, rubella, measles, or any vaccine containing •J '• any of the foregoing as a component). 3 days (for DT, Td, or tetanus toxoid). C. Residual seizure disorder in accordance with subsection (c)(2) 15 days (for mumps, rubella, measles, or any vaccine containing •\f^, any of the foregoing as a compo' ' nent). 3 days (for DT. Td, or teta' ' nus toxoid). D. Any acute complication or sequela (including death) of an illness, disability, injury, or condition re.,. ferred to above which illness, disability, injury, or condition arose within the time period prescribed... Not applicable m. Polio Vaccines (other than Inactivated Polio Vaccine).... „,».,, ,,...,, \ . ijam A. Paralytic polio ^ ' ' -• ^ -

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text: Dictionary of National Biography, 1885-1900/Paterson, Alexander


text:
Page:United States Statutes at Large Volume 100 Part 5.djvu/291

 PUBLIC LAW 99-660—NOV. 14, 1986

IV.

'

—in a non-immunodeficient recipient —in an immunodeficient recipient —in a vaccine-associated community case B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed... Inactivated Polio Vaccine. A. Anaphylaxis or anaphylactic shock B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed...

100 STAT. 3765

'

30 days 6 months Not applicable

Not applicable 24 hours

Not applicable

"(b) QUALIFICATIONS AND AIDS TO INTERPRETATION.—The following

qualifications and aids to interpretation shall apply to the Vaccine Injury Table in subsection (a): "(1) A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of consciousness, loss of consciousness, prolonged sleeping with difficulty arousing, or cardiovascular or respiratory arrest. "(2) A petitioner may be considered to have suffered a residual seizure disorder if the petitioner did not suffer a seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit before the first seizure or convulsion after the administration of the vaccine involved and if— "(A) in the case of a measles, mumps, or rubella vaccine or any combination of such vaccines, the first seizure or convulsion occurred within 15 days after administration of the vaccine and 2 or more seizures or convulsions occurred ' • within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of ^'' less than 102 degrees Fahrenheit, and "(B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of •"" less than 102 degrees Fahrenheit. "(3)(A) The term 'encephalopathy' means any significant acquired abnormality of, or injury to, or impairment of function of the brain. Among the frequent manifestations of encephalopathy are focal and diffuse neurologic signs, increased intracranial pressure, or changes lasting at least 6 hours in level of consciousness, with or without convulsions. The neurological signs and symptoms of encephalopathy may be temporary with complete recovery, or may result in various degrees of permanent impairment. Signs and symptoms such as high

/

.

_;,

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text:
Page:United States Statutes at Large Volume 100 Part 5.djvu/292

 100 STAT. 3766

PUBLIC LAW 99-660—NOV. 14, 1986 pitched and unusual screaming, persistent unconsolable crying, and bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram. "(B) If in a proceeding on a petition it is shown by a preponderance of the evidence that an encephalopathy was caused by infection, toxins, trauma, or metabolic disturbances the encephalopathy shall not be considered to be a condition set forth in the table. If at the time a judgment is entered on a petition filed under section 2111(b) for a vaccine-related injury or death it is not possible to determine the cause, by a preponderance of the evidence, of an encephalopathy, the encephalopathy shall be considered to be a condition set forth in the table. In determining whether or not an encephalopathy is a condition set forth in the table, the court shall consider the entire medical record. "(4) For purposes of paragraphs (2) and (3), the terms 'seizure' and 'convulsion' include grand mal, petit mal, absence, myoclonic, tonic-clonic, and focal motor seizures and signs. If a provision of the table to which paragraph (1), (2), (3), or (4) applies is revised under subsection (c) or (d), such paragraph shall not apply to such provision after the effective date of the revision unless the revision specifies that such paragraph is to continue to apply. '(c) ADMINISTRATIVE REVISION OF THE TABLE.—

Regulations.

Federal Register, publication.

"(1) The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury Table. In promulgating such regulations, the Secretary shall provide for notice and opportunity for a public hearing and at least 180 days of public comment. "(2) Any person (including the Advisory (Ilommission on Childhood Vaccines) may petition the Secretary to propose rq^lations to amend the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission, any such petition shall be referred to the (Dommission for its recommendations. Following— "(A) receipt of any recommendation of the Commission, or "(B) 180 days after the date of the referral to the Commission, whichever occurs first, the Secretary shall conduct a rulemsiking proceeding on the matters proposed in the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding. "(3) A modification of the Vaccine Injury Table under paragraph (1) may add to, or delete from, the list of injuries, disabilities, illnesses, conditions, and deaths for which compensation may be provided or may change the time periods for the first symptom or manifestation of the onset or the significant aggravation of any such injury, disability, illness, condition, or death. "(4) Any modification under paragraph (1) of the Vaccine Injury Table shall apply only with respect to petitions for compensation under the Program which are filed after the effective date of such regulation.

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Page:United States Statutes at Large Volume 100 Part 5.djvu/293

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3767

"(d) ROLE OF COMMISSION.—Except with respect to a regulation Regulations. recommended by the Advisory Commission on Childhood Vaccines, the Secretary may not propose a regulation under subsection (c) or any revision thereof, unless the Secretary has first provided to the Commission a copy of the proposed regulation or revision, requested recommendations and comments by the Commission, and afforded the Commission at least 90 days to make such recommendations. "(e) RECOMMENDATION.—The Secretary may recommend to Congress revisions of the table to change the vaccines covered by the table. "COMPENSATION "SEC. 2115. (a) GENERAL RULE.—Compensation awarded under the

42 USC

Program to a petitioner under section 2111 for a vaccine-related 300aa-15. injury or death associated with the administration of a vaccine after the effective date of this subtitle shall include the following: "(1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and reasonable projected unreimbursable expenses which— "(i) result from the vaccine-related injury for which the petitioner seeks compensation, "(ii) have been or will be incurred by or on behalf of the person who suffered such injury, and "(iii)(I) have been or will be for diagnosis and medical or other remedial care determined to be reasonably necessary, or "(II) have been or will be for rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary. The amount of unreimbursable expenses which may be recovered under this subparagraph shall be limited to the amount in excess of the amount set forth in section 2111(c)(l)(D)(ii). "(B) Subject to section 2116(a)(2), actual unreimbursable expenses incurred before the date of the judgment awarding such expenses which— "(i) resulted from the vaccine-related injury for which the petitioner seeks compensation, "(ii) were incurred by or on behalf of the person who suffered such injury, and "(iii) were for diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary. The amount of unreimbursable expenses which may be recovered under this subparagraph shall be limited to the amount in excess of the amount set forth in section 2111(c)(l)(D)(ii). "(2) In the event of a vaccine-related death, an award of $250,000 for the estate of the deceased. "(3)(A) In the case of any person who has sustained a vaccinerelated injury after attaining the age of 18 and whose earning

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text: Dictionary of National Biography, 1885-1900/Paterson, Charles William


text:
Page:United States Statutes at Large Volume 100 Part 5.djvu/294

 100 STAT. 3768 «*-'

"0—

'•'

PUBLIC LAW 99-660—NOV. 14, 1986

capacity is or has been impaired by reason of such person's vaccine-related injury for which compensation is to be awarded, compensation for actual and anticipated loss of earnings determined in accordance with generally recognized actuarial principles and projections. "(B) In the case of any person who heis sustained a vaccinerelated injury before attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person's vaccine-related injury for which compensation is to be awarded and whose vaccine-related injury is of sufficient severity to permit reasonable anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of I workers in the private, non-farm sector, less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary. •1 "(4) For actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000. Pajnnents for projected expenses shall be paid on a periodic basis 0)ut no payment may be made for a period in excess of 1 year). Payments for pain and suffering and emotional distress and incurred expenses may be paid in a lump sum. "Q)) VACCINES ADMINISTERED BEFORE THE EFFECTIVE DATE.—Com-

pensation awarded under the Program to a petitioner under section 2111 for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this subtitle shall only include the compensation described in paragraphs (I)(A) and (2) of subsection (a). "(c) RESIDENTIAL AND CUSTODIAL CARE AND SERVICE.—The amount of any compensation for residential and custodial care and service expenses under subsection (a)(1) shall be sufficient to enable the compensated person to remain living at home. "(d) TYPES OF COMPENSATION PROHIBITED.—(Dompensation awarded

under the Program may not include the following: "(1) Punitive or exemplary damages. "(2) Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a), compensation for other H than the health, education, or welfare of the person who suffered the vaccine-related injury with respect to which the compensation is paid. "(e) ATTORNEYS' FEES.—

Courts, U.S.

i

'a > lir

"(1) The judgment of a court on a petition filed under section 2111 awarding compensation shall include an amount to cover— "(A) reasonable attorneys' fees, and "(B) other costs, incurred in any proceeding on such petition. If the judgment of a court on such a petition does not award compensation, the court may include in the judgment an amount to cover petitioner's reasonable attorneys' fees and other costs incurred in any proceeding on such petition if the court determines that the civil action was brought in good faith and there was a reasonable basis for the claim for which the civil action was brought. "(2) If the petitioner, before the effective date of this title, filed a civil action for damages for any vaccine-related injury or death for which compensation may be awarded under the Pro-

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