1 | 1 | | I |
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2 | 2 | | 119THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION H. R. 1794 |
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5 | 5 | | To amend the Federal Food, Drug, and Cosmetic Act to establish an Abraham |
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6 | 6 | | Accords Office within Food and Drug Administration, and for other purposes. |
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7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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8 | 8 | | MARCH3, 2025 |
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9 | 9 | | Mrs. H |
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10 | 10 | | ARSHBARGER (for herself, Mr. VARGAS, Mr. WEBERof Texas, Mr. |
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11 | 11 | | P |
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12 | 12 | | ETERS, Mr. HARRISof Maryland, and Mr. LEVIN) introduced the fol- |
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13 | 13 | | lowing bill; which was referred to the Committee on Energy and Com- |
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14 | 14 | | merce |
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15 | 15 | | A BILL |
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16 | 16 | | To amend the Federal Food, Drug, and Cosmetic Act to |
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17 | 17 | | establish an Abraham Accords Office within Food and |
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18 | 18 | | Drug Administration, and for other purposes. |
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19 | 19 | | Be it enacted by the Senate and House of Representa-1 |
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20 | 20 | | tives of the United States of America in Congress assembled, 2 |
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21 | 21 | | SECTION 1. SHORT TITLE. 3 |
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22 | 22 | | This Act may be cited as the ‘‘United States-Abra-4 |
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23 | 23 | | ham Accords Cooperation and Security Act of 2025’’. 5 |
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25 | 25 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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26 | 26 | | •HR 1794 IH |
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27 | 27 | | SEC. 2. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 1 |
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28 | 28 | | WITHIN FOOD AND DRUG ADMINISTRATION. 2 |
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29 | 29 | | (a) I |
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30 | 30 | | NGENERAL.—Chapter X of the Federal Food, 3 |
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31 | 31 | | Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-4 |
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32 | 32 | | ed by adding at the end the following: 5 |
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33 | 33 | | ‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 6 |
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34 | 34 | | ‘‘(a) I |
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35 | 35 | | NGENERAL.—The Secretary, acting through 7 |
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36 | 36 | | the Commissioner of Food and Drugs, shall establish with-8 |
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37 | 37 | | in the Food and Drug Administration an office, to be 9 |
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38 | 38 | | known as the Abraham Accords Office, to be headed by 10 |
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39 | 39 | | a director. 11 |
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40 | 40 | | ‘‘(b) O |
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41 | 41 | | FFICE.—Not later than 2 years after the date 12 |
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42 | 42 | | of enactment of this section, the Secretary shall— 13 |
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43 | 43 | | ‘‘(1) in consultation with the governments of 14 |
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44 | 44 | | Abraham Accords countries, as well as appropriate 15 |
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45 | 45 | | United States Government diplomatic and security 16 |
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46 | 46 | | personnel— 17 |
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47 | 47 | | ‘‘(A) select the location of the Abraham 18 |
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48 | 48 | | Accords Office in an Abraham Accords country; 19 |
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49 | 49 | | and 20 |
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50 | 50 | | ‘‘(B) establish such office; and 21 |
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51 | 51 | | ‘‘(2) assign to such office such personnel of the 22 |
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52 | 52 | | Food and Drug Administration as the Secretary de-23 |
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53 | 53 | | termines necessary to carry out the functions of 24 |
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54 | 54 | | such office. 25 |
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57 | 57 | | •HR 1794 IH |
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58 | 58 | | ‘‘(c) DUTIES.—The Secretary, acting through the Di-1 |
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59 | 59 | | rector of the Abraham Accords Office, shall— 2 |
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60 | 60 | | ‘‘(1) after the Abraham Accords Office is estab-3 |
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61 | 61 | | lished— 4 |
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62 | 62 | | ‘‘(A) as part of the Food and Drug Admin-5 |
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63 | 63 | | istration’s work to strengthen the international 6 |
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64 | 64 | | oversight of regulated commodities, provide 7 |
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65 | 65 | | technical assistance to regulatory partners in 8 |
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66 | 66 | | Abraham Accords countries on strengthening 9 |
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67 | 67 | | regulatory oversight and converging regulatory 10 |
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68 | 68 | | requirements for the oversight of regulated 11 |
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69 | 69 | | products, including good manufacturing prac-12 |
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70 | 70 | | tices and other issues relevant to manufacturing 13 |
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71 | 71 | | medical products that are regulated by the 14 |
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72 | 72 | | Food and Drug Administration; and 15 |
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73 | 73 | | ‘‘(B) facilitate interactions between the 16 |
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74 | 74 | | Food and Drug Administration and interested 17 |
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75 | 75 | | parties in Abraham Accords countries, including 18 |
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76 | 76 | | by sharing relevant information regarding 19 |
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77 | 77 | | United States regulatory pathways with such 20 |
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78 | 78 | | parties, and facilitate feedback on the research, 21 |
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79 | 79 | | development, and manufacturing of products 22 |
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80 | 80 | | regulated in accordance with this Act; and 23 |
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83 | 83 | | •HR 1794 IH |
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84 | 84 | | ‘‘(2) carry out other functions and activities as 1 |
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85 | 85 | | the Secretary determines to be necessary to carry 2 |
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86 | 86 | | out this section. 3 |
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87 | 87 | | ‘‘(d) A |
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88 | 88 | | BRAHAMACCORDSCOUNTRYDEFINED.—In 4 |
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89 | 89 | | this section, the term ‘Abraham Accords country’ means 5 |
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90 | 90 | | a country identified by the Department of State as having 6 |
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91 | 91 | | signed the Abraham Accords Declaration. 7 |
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92 | 92 | | ‘‘(e) N |
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93 | 93 | | ATIONALSECURITY.—Nothing in this section 8 |
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94 | 94 | | shall be construed to require any action inconsistent with 9 |
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95 | 95 | | a national security recommendation provided by the Fed-10 |
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96 | 96 | | eral Government.’’. 11 |
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97 | 97 | | (b) R |
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98 | 98 | | EPORT TOCONGRESS.— 12 |
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99 | 99 | | (1) I |
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100 | 100 | | N GENERAL.—Not later than 3 years after 13 |
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101 | 101 | | the date of enactment of this Act, the Secretary of 14 |
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102 | 102 | | Health and Human Services shall submit to the 15 |
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103 | 103 | | Congress a report on the Abraham Accords Office, 16 |
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104 | 104 | | including— 17 |
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105 | 105 | | (A) an evaluation of how the Office has ad-18 |
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106 | 106 | | vanced progress toward conformance with Food 19 |
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107 | 107 | | and Drug Administration regulatory require-20 |
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108 | 108 | | ments by manufacturers in the Abraham Ac-21 |
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109 | 109 | | cords countries; 22 |
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110 | 110 | | (B) a numerical count of parties that the 23 |
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111 | 111 | | Office has helped facilitate interactions or feed-24 |
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112 | 112 | | back pursuant to section 1015(c)(1)(B) of the 25 |
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115 | 115 | | •HR 1794 IH |
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116 | 116 | | Federal Food, Drug, and Cosmetic Act (as 1 |
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117 | 117 | | added by subsection (a)); 2 |
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118 | 118 | | (C) a summary of technical assistance pro-3 |
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119 | 119 | | vided to regulatory partners in Abraham Ac-4 |
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120 | 120 | | cords countries pursuant to subparagraph (A) 5 |
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121 | 121 | | of such section 1015(c)(1); and 6 |
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122 | 122 | | (D) recommendations for increasing and 7 |
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123 | 123 | | improving coordination between the Food and 8 |
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124 | 124 | | Drug Administration and entities in Abraham 9 |
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125 | 125 | | Accords countries. 10 |
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126 | 126 | | (2) A |
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127 | 127 | | BRAHAM ACCORDS COUNTRY DEFINED .— 11 |
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128 | 128 | | In this subsection, the term ‘‘Abraham Accords 12 |
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129 | 129 | | country’’ has the meaning given such term in section 13 |
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130 | 130 | | 1015(d) of the Federal Food, Drug, and Cosmetic 14 |
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131 | 131 | | Act (as added by subsection (a)). 15 |
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132 | 132 | | Æ |
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