Each such numbered certification shall also contain an item indicating whether any offset agreement is proposed to be entered into in connection with such export and a description of any such offset agreement. In a case in which such articles or services are listed on the Missile Technology Control Regime Annex and are intended to support the design, development, or production of a Category I space launch vehicle system , such report shall include a description of the proposed export and rationale for approving such export, including the consistency of such export with United States missile nonproliferation policy. As prescribed in regulations issued under this section, every person who engages in the business of manufacturing, exporting, or importing any defense articles or defense services designated by the President under subsection shall register with the United States Government agency charged with the administration of this section, and shall pay a registration fee which shall be prescribed by such regulations. Such regulations shall prohibit the return to the United States for sale in the United States of any military firearms or ammunition of United States manufacture furnished to foreign governments by the United States under this chapter or any other foreign assistance or sales program of the United States, whether or not enhanced in value or improved in condition in a foreign country. This prohibition shall not extend to similar firearms that have been so substantially transformed as to become, in effect, articles of foreign manufacture.
If the President determines it to be in the national interest pursuant to subsection of this section, billings for sales made under letters of offer issued under this section after June 30, 1976, may be dated and issued upon delivery of the defense article or rendering of the defense service and shall be due and payable upon receipt thereof by the purchasing country or international organization. Interest shall be charged on any net amount due and payable which is not paid within sixty days after the date of such billing. The rate of interest charged shall be a rate not less than a rate determined by the Secretary of the Treasury taking into consideration the current average market yield on outstanding short-term obligations of the United States as of the last day of the month preceding the billing and shall be computed from the date of billing. The President may, if he determines it to be in the national interest, issue letters of offer under this section which provide for billing upon delivery of the defense article or rendering of the defense service and for payment within one hundred and twenty days after the date of billing.
Appropriations available to the Department of Defense may be used to meet the payments required by the contracts for the procurement of defense articles and defense services and shall be reimbursed by the amounts subsequently received from the country or international organization to whom articles or services are sold. Acquisition under this subchapter of items for which the initial issue quantity requirements for United States Armed Forces have not been fulfilled and are not under current procurement contract shall be emphasized when compatible with security assistance requirements for the transfer of such items. The President is authorized to finance the procurement of defense articles, defense services, and design and construction services by friendly foreign countries and international organizations, on such terms and conditions as he may determine consistent with the requirements of this section. In carrying out this chapter, special emphasis shall be placed on procurement in the United States, but, subject to the provisions of subsection of this section, consideration shall also be given to coproduction or licensed production outside the United States of defense articles of United States origin when such production best serves the foreign policy, national security, and economy of the United States. For purposes of this subparagraph, references in this subsection to sales shall be deemed to be references to enhancements or upgrades in the sensitivity of technology or the capability of major defense equipment, articles, or services, as the case may be.
Subsec. "a description of the article or service proposed to be transferred, including its acquisition cost" for "a description of the defense article or related training or other defense service proposed to be transferred, including the original acquisition cost of such defense article or related training or other defense service", in subpar. "article or service" for "defense article or related training or other defense service", and in provision following subpar. "articles or services" for "defense articles, or related training or other defense services,". Nothing in this subsection shall be construed as authorizing the withholding of information from the Congress.
Notwithstanding section 11 of the Export Administration Act of 1979, the civil penalty for each violation involving controls imposed on the export of defense articles and defense services under this section may not exceed $500,000. Interest shall be charged on any net amount by which any such country or international organization is in arrears under all of its outstanding unliquidated dependable undertakings, considered collectively. The rate of interest charged shall be a rate not less than a rate determined by the Secretary of the Treasury taking into consideration the current average market yield on outstanding short-term obligations of the United States as of the last day of the month preceding the net arrearage and shall be computed from the date of net arrearage. 1976—Pub. In considering a request for approval of any transfer of any weapon, weapons system, munitions, aircraft, military boat, military vessel, or other implement of war to another country, the President shall not give his consent under paragraph to the transfer unless the United States itself would transfer the defense article under consideration to that country. The President shall promptly submit a report to the Speaker of the House of Representatives, the Committee on Foreign Affairs of the House of Representatives, and to the Committee on Foreign Relations of the Senate on the implementation of each agreement entered into pursuant to clause of this subsection.
In furtherance of world peace and the security and foreign policy of the United States, the President is authorized to control the import and the export of defense articles and defense services and to provide foreign policy guidance to persons of the United States involved in the export and import of such articles and services. The President is authorized to designate those items which shall be considered as defense articles and defense services for the purposes of this section and to promulgate regulations for the import and export of such articles and services. The items so designated shall constitute the United States Munitions List.
1973—Pub. 93–189 struck out subsec. Which required the Secretary of State to transmit to the Speaker of the House of Representatives and the Committee on Foreign Relations of the Senate semiannual reports of all exports of significant defense articles on the United States munitions list to foreign governments, etc., and subsec. Which provided for the inclusion in the presentation material submitted to the Congress during consideration of amendments to this chapter or Acts appropriating funds under authority of this chapter annual tables showing the dollar value of cash and credit foreign military sales orders, commitments to order, etc. 1979—Subsec.
96–92, §13–, designated existing provision as par. 1976—Subsec. 94–329, §205, designated existing provisions as subsec. It shall be the policy of the United States to exert leadership in the world community to bring about arrangements for reducing the international trade in implements of war and to lessen the danger of outbreak of regional conflict and the burdens of armaments. United States programs for or procedures governing the export, sale, and grant of defense articles and defense services to foreign countries and international organizations shall be administered in a manner which will carry out this policy. This section does not affect the ability of a law enforcement officer to remove a firearm or ammunition or license to carry a concealed weapon or concealed firearm from any person or to conduct any search and seizure for firearms or ammunition pursuant to other lawful authority.
Any certification relating to a proposed sale or export of defense articles or defense services under this section to any country in the Middle East other than Israel shall include a determination that the sale or export of the defense articles or defense services will not adversely affect Israel's qualitative military edge over military threats to Israel. Subject to subsection , the President may provide training and related support to military and civilian defense personnel of a friendly foreign country or an international organization. Such training and related support shall be provided by a Secretary of a military department and may include the provision of transportation, food services, health services, and logistics and the use of facilities and equipment. The Congress finds that security assistance surveys prepared by the United States for foreign countries have had a significant impact on subsequent military procurement decisions of those countries. It is the policy of the United States that the results of security assistance surveys conducted by the United States clearly do not represent a commitment by the United States to provide any military equipment to any foreign country. Further, recommendations in such surveys should be consistent with the arms export control policy provided for in this chapter.
" Requirement.—The Secretary of State shall ensure that any license application submitted for the export of defense articles or defense services to Australia or the United Kingdom is expeditiously processed by the Department of State, in consultation with the Department of Defense, without referral to any other Federal department or agency, except where the item is classified or exceptional circumstances apply. The law enforcement agency holding any firearm or ammunition or license to carry a concealed weapon or firearm that has been surrendered pursuant to this section shall be notified of the court order to vacate the risk protection order. Members on the council shall develop memoranda of agreement among and between themselves to ensure clarity of roles and responsibilities in providing services to victims of domestic violence. Your quality control department is responsible for approving all raw materials, packaging materials and finished products.
It is very important for this department to exercise adequate controls to ensure the quality of the end product. No lot or batch of a raw material or packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the person in charge of the quality control department approves the use. No defense article or defense service acquired by the Secretary of Defense under this subchapter may be transferred to any foreign country or international organization unless such transfer is authorized by this chapter, the Foreign Assistance Act of 1961 [22 U.S.C. 2151 et seq.], or other law. Except for laws specified in this section, other provisions inapplicable to this chapter without a specific reference thereto or to sales of defense articles and defense services under any Act, see section 45 of Pub. 90–629, set out as a note under section 2751 of this title. The designation by the President (or by an official to whom the President's functions under subsection have been duly delegated), in regulations issued under this section, of items as defense articles or defense services for purposes of this section shall not be subject to judicial review.
Such reciprocal training and related support must be provided within a reasonable period of time of the provision of training and related support by the United States. Each agreement for a cooperative project shall provide that the United States and each of the other participants will contribute to the cooperative project its equitable share of the full cost of such cooperative project and will receive an equitable share of the results of such cooperative project. The full costs of such cooperative project shall include overhead costs, administrative costs, and costs of claims. The United States and the other participants may contribute their equitable shares of the full cost of such cooperative project in funds or in defense articles or defense services needed for such cooperative project. Military assistance and financing received from the United States Government may not be used by any other participant to provide its share of the cost of such cooperative project.
Such agreements shall provide that no requirement shall be imposed by a participant for worksharing or other industrial or commercial compensation in connection with such agreement that is not in accordance with such agreement. 97–113 added par. Which incorporated provisions of former par. Former par. Redesignated .
" Secretary of state concurrence required for certain sales or transfers to foreign countries.—If the sale or transfer of defense articles occurs in accordance with a provision of law referred to in paragraph that does not otherwise require the concurrence of the Secretary of State for the sale or transfer, the sale or transfer may be made only with the concurrence of the Secretary of State. Those under section 3 of the Act (22 U.S.C. 2753), with the exception of subsections , , , , and (22 U.S.C. 2753, , , , and ), to the Secretary of State. The Department of Agriculture and Consumer Services shall deny a license if the applicant has been found guilty of, had adjudication of guilt withheld for, or had imposition of sentence suspended for one or more crimes of violence constituting a misdemeanor, unless 3 years have elapsed since probation or any other conditions set by the court have been fulfilled or the record has been sealed or expunged. The Department of Agriculture and Consumer Services shall revoke a license if the licensee has been found guilty of, had adjudication of guilt withheld for, or had imposition of sentence suspended for one or more crimes of violence within the preceding 3 years. The department shall, upon notification by a law enforcement agency, a court, or the Florida Department of Law Enforcement and subsequent written verification, suspend a license or the processing of an application for a license if the licensee or applicant is arrested or formally charged with a crime that would disqualify such person from having a license under this section, until final disposition of the case. The department shall suspend a license or the processing of an application for a license if the licensee or applicant is issued an injunction that restrains the licensee or applicant from committing acts of domestic violence or acts of repeat violence.
You may release for sale a lot or batch of the finished product selected for ongoing periodic confirmatory testing before all tests are completed if a specific identity test is performed and your quality control department approves. If you are an importer of drugs fabricated, packaged/labelled and tested at recognized buildings authorized by a regulatory authority and identified on your drug establishment licence – You only need to have a batch certificate for each lot or batch of the drug received to show you comply with finished product specifications. Re-testing, including identity testing, is not required when the drug is fabricated, packaged/labelled and tested in an MRA country. All arrangements for external testing must comply with the marketing authorization for the drug product concerned (including the testing of in-process drugs, intermediates, raw materials, packaging materials, and all other testing required by Part C, Division 2 of the Regulations).
Your quality control department must ensure that raw materials and packaging materials are quarantined, sampled, tested and released before being used to fabricate or package/label a drug. Except in the case of a wholesaler or a distributor referred to in paragraph C.01A.003, no lot or batch of a drug may be made available for further use in fabrication or for sale unless the person in charge of the quality control department approves the further use or the sale. " Applicability.—The certification requirement under paragraph applies with respect to each Russian person that, as of the date of the certification, is a party to an agreement relating to commercial cooperation on MTCR equipment or technology with a United States person pursuant to an arms export license that was issued at any time since January 1, 2000. " Use of Assessment.—The President shall ensure that the assessment required under subsection is used to inform the review by the United States of applications to sell defense articles and defense services under the Arms Export Control Act (22 U.S.C. 2751 et seq.) to countries in the Middle East. The President may sell design and construction services to any eligible foreign country or international organization if such country or international organization agrees to pay in United States dollars not less than the full cost to the United States Government of furnishing such services. Payment shall be made to the United States Government in advance of the performance of such services by officers or employees of the United States Government.
97–113 incorporated, in subsec. Introductory text and subsec. Which had required transmission to Congress on or before Nov. 15 of each year executive estimates of international arms traffic, including estimates on an annual basis of the sale and delivery of weapons and weapons-related defense equipment by all major arms suppliers to all major recipient countries during the preceding three years. 97–113 incorporated in subsec.
Which had required Presidential six month written notifications of Congress of any change in the Arms Sales Proposal for such fiscal year, together with reasons therefor. Which incorporated provisions of former subsec. Covered in par. " Enhanced support for defense cooperation with the Republic of Korea is important to the national security of the United States, including through creation of a status in law for the Republic of Korea similar to the countries in the North Atlantic Treaty Organization, Japan, Australia, and New Zealand, with respect to consideration by Congress of foreign military sales to the Republic of Korea." " Pilot Program Authorized.—The Secretary of Defense may carry out a pilot program to repair, overhaul, or refurbish in-stock defense articles in anticipation of the sale or transfer of such defense articles to eligible foreign countries or international organizations under law. 97–113, §101, struck out subpar.
Of this section not apply to transfers to the North Atlantic Treaty Organization, any member country of such organization, Japan, Australia, or New Zealand, of any major defense equipment valued at less than $7,000,000 or of any defense article or related training or other defense service valued at less than $25,000,000. 94–329, title II, §217, June 30, 1976, 90 Stat. 747, set forth provisions respecting report by the President of all sales under this chapter of excess defense articles to foreign governments and international organizations, prior to repeal by Pub.
95–384, §29, Sept. 26, 1978, 92 Stat. 93–189 inserted last paragraph relating to a reduction by the United States in the furnishing of defense articles and defense services to foreign countries. Evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored according to the procedures described in the master production documents 1.
Fabricators must have complete records of all manufacturing activities, including executed batch documentation and release information (e.g. certificates of analysis and associated records) for raw materials and drugs in dosage form. Avoid any deviation from instructions or procedures. If deviations happen record them — have qualified personnel investigate and write a report that describes the deviation, the investigation, the impact of the deviation, the rationale for disposition of any associated materials or products, and any follow-up activities required. Your quality control department must approve the report and maintain records. Ensure that when you receive raw materials, packaging materials, intermediates and bulk drugs, you account for, document, label and hold them in quarantine until they are released by your quality control department. You must take measures to maintain the integrity of a drug product.
This includes from the moment the raw materials enter your plant to the time you release the finished dosage form for sale and distribution. These measures should be documented to ensure that all of your processes are clearly defined, monitored, and systematically reviewed. They also demonstrate that your processes can consistently provide drug products that comply with their established specifications for quality.
Ensure each raw material used to produce a drug is covered by specifications (see section C.02.002). These specifications must be approved and dated by the person in charge of your quality control department or by a designated alternate who meets the requirements described under section C.02.006, interpretation 1.d. You must only release raw materials, packaging materials and products for use or sale if their quality is satisfactory. Quality control ensures that you carry out the necessary and relevant tests to ensure quality. It is not only done in labs—you must incorporate quality control into all activities and decisions about the quality of your products.
Not more than one such certification may be transmitted for a country with respect to the same detonation, transfer, or receipt of a nuclear explosive device. 1977—Subsec. For purposes of this section, defense articles and defense services sold, leased, or exported under this chapter or the Foreign Assistance Act of 1961 (22 U.S.C. 2151 et seq.) includes defense articles and defense services that are transferred to a third country or other third party. 111–266, §103, substituted "defense services, including defense articles and defense services exported or imported pursuant to a treaty referred to in subsection ," for "defense services,".
It is the sense of the Congress that the problems of Sub-Saharan Africa are primarily those of economic development and that United States policy should assist in limiting the development of costly military conflict in that region. Therefore, the President shall exercise restraint in selling defense articles and defense services, and in providing financing for sales of defense articles and defense services, to countries in Sub-Saharan Africa. The President may guarantee any individual, corporation, partnership, or other juridical entity doing business in the United States against political and credit risks of nonpayment arising out of their financing of credit sales of defense articles, defense services, and design and construction services to friendly countries and international organizations. Fees shall be charged for such guaranties. Of the amounts made available for a fiscal year to carry out this section, not more than $100,000,000 for such fiscal year may be made available for countries other than Israel and Egypt for the purpose of financing the procurement of defense articles, defense services, and design and construction services that are not sold by the United States Government under this chapter. " shall cover the period beginning on the date of receipt of a complete letter of request from a foreign country and ending on the date of the final delivery of a defense article or defense service sold through the foreign military sale.
Such reports shall include a description of the facts and circumstances of any such discrimination, the response thereto on the part of the United States or any agency or employee thereof, and the result of such response, if any. The Office of the State Courts Administrator shall develop and prepare instructions and informational brochures, standard petitions and risk protection order forms, and a court staff handbook on the risk protection order process. The standard petition and order forms must be used after January 1, 2019, for all petitions filed and orders issued pursuant to this section. The office shall determine the significant non-English-speaking or limited English-speaking populations in the state and prepare the instructions and informational brochures and standard petitions and risk protection order forms in such languages.
The instructions, brochures, forms, and handbook must be prepared in consultation with interested persons, including representatives of gun violence prevention groups, judges, and law enforcement personnel. Materials must be based on best practices and must be available online to the public. However, this subsection does not preclude a natural person from bringing an action against a firearms or ammunition manufacturer, firearms trade association, firearms or ammunition distributor, or firearms or ammunition dealer for breach of a written contract, breach of an express warranty, or injuries resulting from a defect in the materials or workmanship in the manufacture of a firearm or ammunition. Notwithstanding any other law, for the purposes of safety, security, personal protection, or any other lawful purpose, a person licensed under this section may carry a concealed weapon or firearm on property owned, rented, leased, borrowed, or lawfully used by a church, synagogue, or other religious institution.
This subsection does not limit the private property rights of a church, synagogue, or other religious institution to exercise control over property that the church, synagogue, or other religious institution owns, rents, leases, borrows, or lawfully uses. Consular security official licenses shall be valid for 1 year and may be renewed upon completion of the application process as provided in this section. If you are a distributor (as described in paragraph C.01A.003) or an importer of a drug, you must retain in Canada a sample of each lot or batch of a finished product. Keep retention samples in their trade package, or in a container that is equivalent with respect to stability.
In the case of large containers of finished products, you may retain a smaller representative sample, as supported by stability data. This allowance does not apply to sterile products. As long as the material is properly identified, you may use the lot of packaging material selected for confirmatory testing in packaging before completing that testing. Your quality control department must approve use before completing testing. No lot or batch of a drug shall be reprocessed unless the person in charge of the quality control department approves the reprocessing.
Your distribution records must enable tracing of each drug product. This includes any products in transit, any samples that have been removed by the quality control department, and any professional samples that have been distributed. Only use raw materials that have been released by your quality control department and are not past their established re-test date or expiry date in fabrication. If you have any raw material in storage after the established re-test date, you must quarantine it. The requirement contained in the preceding sentence shall not apply to licenses for exports to countries that were members of the MTCR as of April 17, 1987. Defense articles in the stocks of the Department of Defense may be leased or loaned to a foreign country or international organization only under the authority of this subchapter or chapter 2 of part II of the Foreign Assistance Act of 1961 [22 U.S.C. 2311 et seq.], and may not be leased to a foreign country or international organization under the authority of section 2667 of title 10.
