section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 14:14:4.0.1.1.9.0.1.1,14,Aeronautics and Space,II,A,213,"PART 213—TERMS, CONDITIONS AND LIMITATIONS OF FOREIGN AIR CARRIER PERMITS",,,,§ 213.1 Applicability.,FAA,,,"[ER-680, 36 FR 7306, Apr. 17, 1971, as amended at 61 FR 34725, July 3, 1996; Doc. No. DOT-OST-2014-0140, 84 FR 15925, Apr. 16, 2019]","This part sets forth terms, conditions, and limitations applicable to foreign air carrier permits issued under section 41302 of Title 49 of the United States Code (Transportation) authorizing scheduled foreign air transportation. Unless such permits or the orders issuing such permits otherwise provide, the exercises of the privileges to engage in scheduled foreign air transportation granted by any such permit shall be subject to the terms, conditions, and limitations as are set forth in this part, and as may from time to time be prescribed by the Department." 14:14:4.0.1.1.9.0.1.2,14,Aeronautics and Space,II,A,213,"PART 213—TERMS, CONDITIONS AND LIMITATIONS OF FOREIGN AIR CARRIER PERMITS",,,,§ 213.2 Reports of traffic data.,FAA,,,"[ER-624, 35 FR 8881, June 9, 1970, as amended at 65 FR 6456, Feb. 9, 2000; Doc. No. DOT-OST-2014-0140, 84 FR 15925, Apr. 16, 2019]",The Department may at any time require any foreign air carrier to file with the Department traffic data disclosing the nature and extent of such carrier's engagement in transportation between points in the United States and points outside thereof. The Department will specify the traffic data required in each such instance. Interested persons seeking reconsideration of a Department determination under this section may file a petition pursuant to § 302.14 of this chapter (Rule 14 of part 302) within 10 days after Department action. 14:14:4.0.1.1.9.0.1.3,14,Aeronautics and Space,II,A,213,"PART 213—TERMS, CONDITIONS AND LIMITATIONS OF FOREIGN AIR CARRIER PERMITS",,,,§ 213.3 Filing and approval of schedules.,FAA,,,"[ER-624, 35 FR 8881, June 9, 1970, as amended by ER-870, 39 FR 30843, Aug. 26, 1974; ER-1107, 47 FR 46495, Oct. 19, 1982; 61 FR 34725, July 3, 1996]","(a) In the absence of provisions to the contrary in the permit and of Department action pursuant to this section, a foreign air carrier may determine the schedules (including type of equipment used) pursuant to which it engages in transportation between points in the United States and points outside thereof. (b) In the case of a foreign air carrier permit for scheduled air transportation which is not the subject of an air transport agreement between the United States and the government of the holder, the Department, if it finds that the public interest so requires, may with or without hearing order the foreign air carrier to file with it within 7 days after service of such order, an original and three copies of any or all of its existing schedules of service between any point in the United States and any point outside thereof, and may require such carrier thereafter to file an original and three copies of any proposed schedules of service between such points at least 30 days prior to the date of inauguration of such service. Such schedules shall contain all schedules of aircraft which are or will be operated by such carrier between each pair of points set forth in the order, the type of equipment used or to be used, the time of arrival and departure at each point, the frequency of each schedule, and the effective date of any proposed schedule. (c) In the case of any foreign air carrier permit for scheduled air transportation which is the subject of an air transport agreement between the United States and the government of the holder, the Department may with or without hearing issue an order, similar to that provided for in paragraph (b) of this section, if it makes the findings provided for in that subsection and, in addition, finds that the government or aeronautical authorities of the government of the holder, over the objections of the U.S. Government, have: (1) Taken action which impairs, limits, terminates, or denies operating rights, or (2) otherwise denied or failed to prevent the denial of, in whole or in part, the fair and equal opportunity to exercise the operating rights, provided for in such air transport agreement, of any U.S. air carrier designated thereunder with respect to flight operations to, from, through, or over the territory of such foreign government. (d) The carrier may continue to operate existing schedules, and may inaugurate operations under proposed schedules 30 days after the filing of such schedules with the Department, unless the Department with or without hearing issues an order, subject to stay or disapproval by the President of the United States within 10 days after adoption, notifying the carrier that such operations, or any part of them, may be contrary to applicable law or may adversely affect the public interest. If the notification pertains to a proposed schedule, service under such schedule shall not be inaugurated; if the notification pertains to existing schedules, service under such schedules shall be discontinued on the date specified in the Department's order. Such date shall be not less than ten days after adoption of the Department's order unless affirmative Presidential approval is obtained at an earlier date. (e) No petitions for reconsideration may be filed with respect to Department orders issued pursuant to paragraph (b), (c), or (d) of this section. Nevertheless, if the Department serves a notification under paragraph (d) of this section, the carrier may make application to the Department for approval of any or all existing or proposed schedules, pursuant to the provisions of § 213.5. The Department may with or without hearing withdraw, in whole or in part, its notification at any time and may permit existing or proposed schedules to be operated for such period or periods as the Department may determine. (f) The date of service on a foreign air carrier of orders and notifications pursuant to this section shall be the date of mailing thereof, by certified or registered mail, to the agent designated by the foreign air carrier pursuant to 49 U.S.C. 46103 or, if the foreign air carrier has failed to designate an agent, the date of mailing by registered air mail to the foreign air carrier's home office." 14:14:4.0.1.1.9.0.1.4,14,Aeronautics and Space,II,A,213,"PART 213—TERMS, CONDITIONS AND LIMITATIONS OF FOREIGN AIR CARRIER PERMITS",,,,§ 213.4 [Reserved],FAA,,,, 14:14:4.0.1.1.9.0.1.5,14,Aeronautics and Space,II,A,213,"PART 213—TERMS, CONDITIONS AND LIMITATIONS OF FOREIGN AIR CARRIER PERMITS",,,,§ 213.5 Filing and service of schedules and applications for approval of schedules; procedure thereon.,FAA,,,"[ER-624, 35 FR 8881, June 9, 1970, as amended by ER-644, 35 FR 14382, Sept. 12, 1970; 61 FR 34725, July 3, 1996; 65 FR 6456, Feb. 9, 2000; DOT-OST-2014-0140, 84 FR 15925, Apr. 16, 2019]","(a) Number of copies and certificate of service. An original and three copies of each schedule, and an original and seven (7) copies of application for approval of schedules (§ 213.3(e)) shall be filed with the Department, each setting forth the names and addresses of the persons, if any, required to be served, and stating that service has been made on all such persons by personal service or by registered or certified mail (if the addressee is located within the United States, its territories and possessions) or by registered air mail (if the addressee is located outside the United States, its territories and possessions) and the date of such service. In the case of service by mail, the date of mailing shall be considered the date of service. (b) Pleadings by interested persons. Any interested person may file and serve upon the foreign air carrier a memorandum in opposition to, or in support of, schedules or an application for approval of schedules within 10 days of the filing opposed or supported. All memoranda shall set forth in detail the reasons for the position taken together with a statement of economic data and other matters which it is desired that the Department officially notice, and affidavits stating other facts relied upon. Memoranda shall contain a certificate of service as prescribed in paragraph (a) of this section. An executed original and seven (7) true copies shall be filed with the Department's Docket Facility. Unless otherwise provided by the Department, further pleadings will not be entertained. (c) Determination and petitions for reconsideration. The Department may make its determination upon the application and other pleadings or, in its discretion, after hearing. Interested persons seeking reconsideration of the Department's determination on an application approval of schedules may file a petition pursuant to § 302.14 of this chapter (Rule 14 of part 302) within 10 days of Department action. Any interested person may file an answer in opposition to, or in support of, the petition within 10 days after it is filed. An executed original and 19 copies of such petition for reconsideration or memorandum shall be filed with the Docket Facility. All petitions for reconsideration shall contain a certificate of service in the form prescribed by paragraph (a) of this section. Unless ordered by the Department upon application or upon its own motion, further pleadings will not be entertained." 14:14:4.0.1.1.9.0.1.6,14,Aeronautics and Space,II,A,213,"PART 213—TERMS, CONDITIONS AND LIMITATIONS OF FOREIGN AIR CARRIER PERMITS",,,,§ 213.6 Compliance.,FAA,,,"[ER-624, 35 FR 8881, June 9, 1970, as amended at 61 FR 34725, July 3, 1996]","Any violation by the foreign air carrier of applicable provisions of Subtitle VII of Title 49 of the U.S. Code or of orders, rules or regulations issued thereunder, or of the terms, conditions or limitations applicable to the exercise of the privileges granted by the permit shall constitute a failure to comply with the terms, conditions and limitations of such permit: Provided, That upon a showing that a violation of a provision not mandatorily prescribed by law resulted from the observance by the holder of an obligation, duty or liability imposed by a foreign country, the Department may excuse the violation." 14:14:4.0.1.1.9.0.1.7,14,Aeronautics and Space,II,A,213,"PART 213—TERMS, CONDITIONS AND LIMITATIONS OF FOREIGN AIR CARRIER PERMITS",,,,§ 213.7 Filing requirements for adherence to Montreal Agreement.,FAA,,,"[ER-1330, 48 FR 8050, Feb. 25, 1983, as amended by ER-1346, 48 FR 31014, July 6, 1983; 61 FR 34725, July 3, 1996]","It shall be a condition upon the holding of a foreign air carrier permit or other authority authorizing direct foreign scheduled air transportation that the holder have and maintain in effect and on file with the Department a signed counterpart of Agreement 18900 (OST Form 4523), and a tariff (for those carriers otherwise generally required to file tariffs) that includes its provisions, and comply with all other requirements of part 203 of this chapter. That form can be obtained from the Foreign Air Carrier Licensing Division (X-45), Office of International Aviation, Department of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590." 21:21:4.0.1.1.13.1.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,A,Subpart A—General Provisions,,§ 213.1 Scope.,FDA,,,,The regulations in this part contain the minimum current good manufacturing practice for preparation of medical gases for administration to humans or animals. 21:21:4.0.1.1.13.1.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,A,Subpart A—General Provisions,,§ 213.3 Definitions.,FDA,,,,"(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable to such terms when used in this part. (b) The following definitions of terms apply to this part: (1) Acceptance criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). (2) Batch means a specific quantity of a medical gas or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. (3) Commingling or commingled refers to the act of combining one lot of designated medical gas or component with another lot or lots of the same designated medical gas or component. (4) Component means any ingredient intended for use in the manufacture of a medical gas, including those that may not appear in such gas. It does not include an incoming designated medical gas. (5) Designated medical gas means a drug that is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; is administered as a gas; and is defined in section 575(1) of the Federal Food, Drug, and Cosmetic Act. (6) FDA means the Food and Drug Administration. (7) In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the medical gas. (8) Incoming designated medical gas means a designated medical gas received from one source that, after receipt, is commingled with the same gas from another source, used in a medically appropriate combination of designated medical gases or in the production of another medical gas, or further distributed. (9) Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a medical gas produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. (10) Lot number, control number, or batch number means any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of medical gas or other material can be determined. (11) Manufacture, processing, packing, or holding of medical gases includes packaging and labeling operations, testing, and quality control. (12) Medical gas has the meaning given the term in section 575(2) of the Federal Food, Drug, and Cosmetic Act. (13) Original manufacturer means the person that initially produces a designated medical gas by chemical reaction, physical separation, compression of atmospheric air, purification ( e.g., re-processing an industrial gas into a medical gas), or other means. (14) Quality unit means any person or persons designated with the authority and responsibility for overall quality management and other responsibilities as defined in § 213.22. (15) Strength means: (i) The concentration of the medical gas (for example, weight/weight, weight/volume, or unit dose/volume basis); and/or (ii) The potency, that is, the therapeutic activity of the medical gas as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard)." 21:21:4.0.1.1.13.10.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.180 General requirements.,FDA,,,,"(a) Record availability. All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred and are subject to copying as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph (a). (b) Record requirements. All records must be legible, stored to prevent deterioration or loss, and original or accurate reproductions of the original records. (c) Record retention period. Except where otherwise provided, all records required to be maintained in compliance with this part must be maintained for a period of at least 3 years after the distribution of the batch of medical gas. (d) Maintenance of written records. Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each medical gas to determine the need for changes in specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for: (1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch; and (2) A review of complaints, recalls, returned or salvaged medical gases, and investigations conducted under § 213.192 for each gas. (e) Written procedure requirements. A firm shall establish and follow written procedures to assure that responsible officials of the firm are notified in writing of any recalls, reports of inspectional observations by FDA, regulatory actions related to good manufacturing practices brought by FDA, or investigations resulting from adverse event complaints." 21:21:4.0.1.1.13.10.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.182 Equipment cleaning and use log.,FDA,,,,"A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 213.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order." 21:21:4.0.1.1.13.10.1.3,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,"§ 213.184 Records for components, medical gas containers and closures, and labeling.",FDA,,,,"Records for components, medical gas containers and closures, and labeling shall include the following: (a) The results of any test or examination performed (including those performed as required by § 213.84 or § 213.122) and the conclusions derived therefrom. (b) Documentation of the examination and review of labels and labeling for conformity with established specifications in accordance with §§ 213.122 and 213.130. (c) The disposition of rejected components, medical gas containers and closures, and labeling." 21:21:4.0.1.1.13.10.1.4,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.186 Master production and control records.,FDA,,,,"(a) To assure uniformity from batch to batch, master production and control records for each medical gas shall be prepared, dated, and signed. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed. (b) Master production and control records shall include: (1) The name and strength of the medical gas; (2) A complete list of components and any incoming designated medical gases used in manufacturing designated by names or codes sufficiently specific to indicate any special quality characteristic; (3) A description of the medical gas containers and closures, packaging materials, and labels; and (4) Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed." 21:21:4.0.1.1.13.10.1.5,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.189 Batch production and control records.,FDA,,,,"(a) Batch production and control records shall be prepared for each batch of medical gas produced. (b) These records shall include documentation that each significant step in the manufacture, processing, packing, or holding of the medical gas produced was accomplished, including: (1) Dates of each significant step, including in-process and laboratory tests as applicable; (2) A description of the container for the medical gas, including the number and size of the containers filled as applicable; (3) Specific identification of each component and its source or in-process material used as applicable; (4) Measures of components used in the course of processing as applicable; (5) Testing results, including any in-process test results and finished product test results; (6) Dated signature or initials of the persons performing and directly supervising or checking each significant step in the operation; (7) Inspection of the packaging and labeling area before and after use; (8) Complete labeling control records, including specimens or copies of all labeling used and label application and reconciliation records as appropriate; and (9) Any investigation made according to § 213.192." 21:21:4.0.1.1.13.10.1.6,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.192 Production record review.,FDA,,,,"(a) Manufacturing production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality unit to determine compliance with all established, approved written procedures before a batch is released or distributed. The quality unit must review production records to determine whether errors or unexplained discrepancies have occurred prior to batch release. If errors or unexplained discrepancies have occurred, or a batch or any component of the batch fails to meet any of its specifications, the firm must thoroughly investigate and take appropriate corrective actions. A written record of the investigation shall be made and shall include the conclusions and followup. (b) For production and control records of filling at a delivery site, quality unit review as described in paragraph (a) of this section shall be within one business day after fill." 21:21:4.0.1.1.13.10.1.7,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.194 Laboratory records.,FDA,,,,"(a) Laboratory records related to the manufacture of a medical gas must include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: (1) A description of the sample, the batch or lot number to be tested, the date the sample was taken, and the date the sample was tested. (2) The method used in the testing of the sample, the result of the test, how the results compare with established standards of identity, strength, quality, and purity for the component, container, closure, in-process materials (as applicable), and medical gas tested, a record of any calculations performed in connection with each test and any calculated results, and the unit of measurement of the result for each test. It is not necessary to provide the actual calculation where the result is evident through use of simple addition and subtraction. (3) Where applicable, any graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, or medical gas for each lot tested. (4) The initials or signature of the person performing the test and the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards. (b) Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method. (c) Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions. (d) Complete records shall be maintained of the periodic calibration or verification of calibration of laboratory instruments, apparatus, gauges, and recording devices required by § 213.160(b)(4). (e) Complete records shall be maintained of all stability testing performed in accordance with § 213.166." 21:21:4.0.1.1.13.10.1.8,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.196 Distribution records.,FDA,,,,"Distribution records shall contain the name of the medical gas, lot or batch number, name and address of the consignee, and date and quantity shipped. For medically appropriate combinations of designated medical gases, the distribution record shall include the percentage of each gas." 21:21:4.0.1.1.13.10.1.9,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,J,Subpart J—Records,,§ 213.198 Complaint files.,FDA,,,,"(a) Written procedures shall be established and followed for the receipt and handling of all written or oral complaints concerning a medical gas. These procedures must include quality unit review of any complaint involving the possible failure of a medical gas to meet any of its specifications and provisions for determining the need for an investigation in accordance with § 213.192 as well as determining whether the complaint represents an event that is required to be reported to FDA under part 230 of this chapter. Any complaint involving a possible leak of a container or closure must be reviewed, evaluated, and investigated in accordance with § 213.192. (b) A written record of each complaint regarding a medical gas must be maintained. The record must include the name of the gas, the lot or batch number, the name of the complainant, the date the complaint was received, the nature of the complaint, and the response to the complaint. It must also include the findings of any investigation and followup. Where an investigation is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination. (c) Complaint files shall be maintained in a manner such that they are readily available for inspection by the firm or by FDA during an inspection. Complaint files shall be maintained for at least 1 year after the date the complaint was received or for at least 3 years after distribution of the medical gas, whichever is longer." 21:21:4.0.1.1.13.11.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,K,Subpart K—Returned and Salvaged Medical Gases,,§ 213.204 Returned medical gases.,FDA,,,,"Returned medical gases shall be identified as such and held. If the conditions under which such returned gases have been held, stored, or shipped before or during their return, or if the condition of the gas, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality, or purity of the gas, the returned gas shall be destroyed unless examination, testing, or other investigations prove the gas meets appropriate standards of safety, identity, strength, quality, or purity. Records of returned medical gases shall be maintained and shall include the name, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned gas. If the reason for a medical gas being returned implicates associated batches, an appropriate investigation shall be conducted in accordance with the requirements of § 213.192. Procedures for the holding, testing, and use of returned medical gases shall be in writing and shall be followed. This section is not applicable to the routine refilling of cryogenic medical gas containers in the normal course of business unless the cryogenic medical gas container was returned due to a quality issue." 21:21:4.0.1.1.13.11.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,K,Subpart K—Returned and Salvaged Medical Gases,,§ 213.208 Salvaging of medical gases.,FDA,,,,"Medical gases in containers that have been subjected to improper storage conditions may be salvaged unless their containers have been subjected to adverse conditions that impact the identity, strength, quality, and purity of the gas or integrity of the container closure. Whenever there is a question whether medical gases have been subjected to such conditions, salvaging operations may be conducted only if there is evidence from laboratory tests that such gases meet all applicable standards of identity, strength, quality, and purity, and the integrity of the container closure system is not compromised. Procedures for the holding, testing, and use of salvaged medical gases shall be in writing and shall be followed." 21:21:4.0.1.1.13.2.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,B,Subpart B—Organization and Personnel,,§ 213.22 Responsibilities of quality unit.,FDA,,,,"(a) There shall be a quality unit that shall have the responsibility and authority to approve or reject all components, medical gas containers and closures, in-process materials, packaging material, labeling, and medical gases, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality unit shall be responsible for approving or rejecting medical gases manufactured, processed, packed, or held under contract by another company. (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, medical gas containers and closures, packaging materials, in-process materials, and medical gases shall be available to the quality unit. (c) The quality unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the medical gas. (d) The responsibilities and procedures applicable to the quality unit shall be in writing; such written procedures shall be followed. (e) Quality unit personnel may perform other functions provided appropriate written controls are in place to ensure any other functions are performed separately from quality unit responsibilities and such other functions do not interfere with the quality unit's responsibilities or subordinate the quality unit's responsibilities to any other unit." 21:21:4.0.1.1.13.2.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,B,Subpart B—Organization and Personnel,,§ 213.25 Personnel qualifications and responsibilities.,FDA,,,,"(a) Each person engaged in the manufacture, processing, packing, or holding of a medical gas shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with current good manufacturing practice requirements applicable to them. Written documentation shall be maintained demonstrating the completion of employee training, and shall include the date of the training, the type of the training, and the results of any completion criteria, such as test results. (b) There shall be an adequate number of qualified personnel to perform the manufacture, processing, packing, or holding of each medical gas. (c) Only authorized personnel shall enter those areas of the buildings and facilities designated as limited-access areas." 21:21:4.0.1.1.13.2.1.3,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,B,Subpart B—Organization and Personnel,,§ 213.34 Consultants.,FDA,,,,"Consultants advising on the manufacture, processing, packing, or holding of medical gases shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide." 21:21:4.0.1.1.13.3.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,C,Subpart C—Buildings and Facilities,,§ 213.42 Design and construction features.,FDA,,,,"(a)(1) Any buildings and facilities used in the manufacture, processing, packing, or holding of a medical gas shall be of adequate design, including having adequate space, for the orderly placement of equipment and materials to prevent mix-ups between: (i) Components; (ii) Incoming designated medical gases; (iii) Medical gas containers and closures; (iv) Labeling; (v) In-process materials; or (vi) Medical gases. (2) Such buildings and facilities shall also allow for adequate cleaning, maintenance, and proper operations. (b)(1) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mix-ups during the course of the following procedures: (i) Receipt, identification, storage, and withholding from use of components, incoming designated medical gases, medical gas containers and closures, and labeling, pending the appropriate sampling, testing, or examination by the quality unit before release for manufacturing or packaging; (ii) Holding rejected components, incoming designated medical gases, medical gas containers and closures, and labeling before disposition; (iii) Storage of released components, incoming designated medical gases, medical gas containers and closures, and labeling; (iv) Storage of in-process materials; (v) Manufacturing and processing operations; (vi) Packaging and labeling operations; (vii) Quarantine storage before release of medical gases; (viii) Storage of medical gases after release; and (ix) Control and laboratory operations. (2) The flow of components, incoming designated medical gases, medical gas containers and closures, labeling, in-process materials, and medical gases through the buildings and facilities shall be designed to prevent contamination and mix-ups. (c) Any building or facility used in the manufacture, processing, packing, or holding of a medical gas shall be maintained in a clean condition so as to assure the safety, identity, strength, quality, and purity of the medical gas. Written procedures applicable to the maintenance and cleaning of buildings and facilities shall be established and followed." 21:21:4.0.1.1.13.4.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,D,Subpart D—Equipment,,"§ 213.63 Equipment design, size, and location.",FDA,,,,"Equipment used in the manufacture, processing, packing, or holding of a medical gas shall be of appropriate design and adequate size, and be suitably located to facilitate operations for its intended use and any necessary cleaning and maintenance." 21:21:4.0.1.1.13.4.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,D,Subpart D—Equipment,,§ 213.65 Equipment construction.,FDA,,,,"(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or medical gases shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements. (b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, containers, closures, in-process materials, or medical gases so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements." 21:21:4.0.1.1.13.4.1.3,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,D,Subpart D—Equipment,,§ 213.67 Equipment maintenance and cleaning.,FDA,,,,"(a) Written procedures shall be established, maintained, and followed for adequate cleaning and maintenance of equipment used in the manufacture, processing, packing, or holding of medical gases. These procedures shall include, but are not necessarily limited to, the following: (1) Assignment of responsibility for cleaning and maintaining equipment; (2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules; (3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance; (4) Removal or obliteration of previous batch identification; (5) Protection of clean equipment from contamination prior to use; and (6) Inspection of equipment for cleanliness immediately before use. (b) The procedures described in paragraph (a) of this section shall not alter the safety, identity, strength, quality, or purity of the medical gas beyond the established requirements. (c) Records shall be kept of cleaning, maintenance, and inspection as specified in §§ 213.180 and 213.182." 21:21:4.0.1.1.13.4.1.4,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,D,Subpart D—Equipment,,"§ 213.68 Automatic, mechanical, and electronic equipment.",FDA,,,,"(a) Automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of medical gases shall be routinely calibrated, inspected, and checked according to a written program designed to ensure proper performance. Written procedures and records of calibration, inspections, and checks shall be maintained. (b) Computerized systems that record, store, or use data shall be appropriately validated. (c) A backup file of data entered into the computer system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. (d) Appropriate change control shall be used whenever modifications are made to computer systems to assure that any changes do not adversely affect data integrity or product quality. Records of such modifications shall be maintained." 21:21:4.0.1.1.13.5.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,E,"Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures",,§ 213.80 General requirements.,FDA,,,,"(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components, incoming designated medical gases, and medical gas containers and closures; such written procedures shall be followed. (b) Components, incoming designated medical gases, and medical gas containers and closures shall at all times be handled and stored in a manner to prevent contamination and mix-ups. (c) Lots of incoming designated medical gases or components, whether used directly as supply or commingled with an existing supply, shall be assigned a unique identification number." 21:21:4.0.1.1.13.5.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,E,"Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures",,§ 213.82 Receipt and storage of incoming designated medical gases.,FDA,,,,"(a)(1) Upon receipt of each shipment of each incoming designated medical gas, the firm shall either perform full compendial testing on the gas and record the results or verify and record that a signed certificate of analysis from the supplier accompanies each different designated medical gas in a shipment. The certificate of analysis shall include the following: (i) Supplier's name; (ii) Name of the incoming designated medical gas; (iii) Lot number or other unique identification number; (iv) Actual analytical result obtained for strength, as well as the results of other tests performed; (v) Identification of the test method(s) used for analysis; (vi) New drug application and/or new animal drug application number of the incoming designated medical gas; and (vii) Supplier representative's signature and the date of signature. (2) If the incoming designated medical gas is obtained from a supplier other than the original manufacturer, the shipment shall also include complete information from the original manufacturer's certificate of analysis. The firm shall establish and maintain a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures. (b) An identity test shall be performed upon receipt of the incoming designated medical gas." 21:21:4.0.1.1.13.5.1.3,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,E,"Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures",,"§ 213.84 Testing and approval or rejection of components, containers, and closures.",FDA,,,,"(a) Components, containers, and closures (including valves) shall be examined for conformance with appropriate written procedures and specifications, and approved or rejected, prior to the manufacturing or filling process. In lieu of such examination by the firm, a statement of verification that the component, container, or closure meets specifications may be accepted from the supplier, provided that the firm establishes and maintains a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing provisions. Any rejected items shall be handled in accordance with § 213.89. (b) Firms shall take appropriate actions to protect against container and closure leaks, which shall include performing leak tests on containers and closures at the time of fill and after fill but prior to release. (c) Each component shall be sampled, tested, and approved or rejected as appropriate prior to use. This requirement can be met by performing testing for conformance with written specifications or by an identity test on the component accompanied by an acceptable certificate of analysis from the supplier, provided that the firm establishes and maintains a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures." 21:21:4.0.1.1.13.5.1.4,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,E,"Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures",,"§ 213.89 Rejected components, incoming designated medical gases, and medical gas containers and closures.",FDA,,,,"Rejected components, incoming designated medical gases, and medical gas containers and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable and shall be documented and assessed." 21:21:4.0.1.1.13.5.1.5,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,E,"Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures",,§ 213.94 Medical gas containers and closures.,FDA,,,,"(a) Medical gas containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the gas beyond the official or established requirements. (b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the medical gas. (c) Medical gas containers and closures shall be clean to assure that they are suitable for their intended use. (d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning shall be written and followed for medical gas containers and closures. (e) Medical gas containers and closures must meet the following requirements— (1) Gas-specific use outlet connections. Portable cryogenic medical gas containers that are not manufactured with permanent gas use outlet connections ( e.g., those that have been silver-brazed) must have gas-specific use outlet connections that are attached to the valve body so that they cannot be readily removed or replaced (without making the valve inoperable and preventing the containers' use) except by the manufacturer. For the purposes of this paragraph (e)(1), the term manufacturer includes any individual or firm that fills high-pressure medical gas cylinders or cryogenic medical gas containers. For the purposes of this section, a portable cryogenic medical gas container is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, healthcare entity, nursing home, other facility, or home healthcare setting, or is used to fill small cryogenic gas containers for use by individual patients. The term excludes cryogenic containers that are not designed to be connected to a medical gas supply system, e.g., tank trucks, trailers, rail cars, or small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter). (2) Gauges for certain medical gas containers. Portable cryogenic medical gas containers as described in paragraph (e)(1) of this section and small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter) must have a working gauge sufficient to assist the user in determining whether the container contains an adequate supply of medical gas for continued use. (3) Label and coloring requirements. The labeling specified at § 201.328(a) of this chapter must be affixed to the container in a manner that does not interfere with other labeling. Each such label as well as materials used for coloring medical gas containers must be reasonably resistant to fading, durable when exposed to atmospheric conditions, and not readily soluble in water." 21:21:4.0.1.1.13.6.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,F,Subpart F—Production and Process Controls,,§ 213.100 Written procedures; deviations.,FDA,,,,"(a) There shall be written procedures for production and process controls designed to assure that medical gases have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality unit. (b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified." 21:21:4.0.1.1.13.6.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,F,Subpart F—Production and Process Controls,,§ 213.101 Charge-in of components and incoming designated medical gases.,FDA,,,,"Written production and control procedures shall include the following, which are designed to assure that the medical gases produced have the identity, strength, quality, and purity they purport or are represented to possess: (a) Except when a monograph or formulary specifies a range, the batch shall be formulated with the intent to provide 100 percent of the labeled or established amount of each medical gas. When a monograph or formulary specifies a range for the contents of a medical gas, the batch shall be formulated with the intent to provide an amount of the medical gas within such specified range. (b) Components and incoming designated medical gases added to in-process supply or final product containers shall be weighed or measured as appropriate. In-process and final product containers shall identify the name of the component or designated medical gas or the name and percentage of each component or designated medical gas if they contain multiple components or designated medical gases, and the unique lot number assigned." 21:21:4.0.1.1.13.6.1.3,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,F,Subpart F—Production and Process Controls,,§ 213.110 Sampling and testing of in-process materials.,FDA,,,,"(a) In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality unit during the production process. (b) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes. (c) Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable." 21:21:4.0.1.1.13.7.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,G,Subpart G—Packaging and Labeling Control,,§ 213.122 Materials examination and usage criteria.,FDA,,,,"(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. Labeling and packaging materials shall be representatively sampled, and examined or tested upon receipt and before use in packaging or labeling of a medical gas. (b) Any labeling or packaging materials meeting appropriate written specifications may be approved and released for use. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are unsuitable. (c) Records shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination, and whether accepted or rejected. (d) Labels and other labeling materials for each different medical gas, strength, or quantity of contents shall be stored with suitable identification to avoid mix-ups. Access to the label storage area shall be limited to authorized personnel. (e) Labels, labeling, and other packaging materials that are obsolete, outdated, or that do not meet applicable requirements shall be destroyed. (f) Packaging and labeling operations shall include one of the following special control procedures: (1) Dedication of labeling and packaging lines to each different strength of each different medical gas; (2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations; or (3) Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of labeling operations for hand-applied labeling. Such examination shall be performed by one person and independently verified by a second person. (g) Printing devices on, or associated with, manufacturing lines used to imprint labeling upon the unit label or case shall be monitored to assure that all imprinting conforms to the print specified in the batch production record. (h) Labels may be reused if they are legible, properly affixed to the container, and otherwise meet all applicable requirements." 21:21:4.0.1.1.13.7.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,G,Subpart G—Packaging and Labeling Control,,§ 213.125 Labeling issuance.,FDA,,,,"(a) Labeling and packaging operations must be controlled to prevent labeling and product mix-ups. Procedures shall be written and followed describing in sufficient detail the control procedures employed for the issuance of labeling. (b) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of medical gas and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with § 213.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with § 213.122(f)(2). Labeling reconciliation is also waived for 360° wraparound labels on portable cryogenic medical gas containers. (c) All excess lot number stickers or decals bearing lot or control numbers shall be discarded. (d) Bulk or transport containers (as defined in § 201.161(c)(3) of this chapter) are exempt from this section." 21:21:4.0.1.1.13.7.1.3,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,G,Subpart G—Packaging and Labeling Control,,§ 213.130 Packaging and labeling operations.,FDA,,,,"There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for medical gases; such written procedures shall be followed. These procedures shall incorporate the following features: (a) Prevention of mix-ups by physical or spatial separation from operations on other products. (b) Identification and handling of filled containers of medical gas that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container. (c) Identification of the medical gas with a lot or control number that permits determination of the history of the manufacture and control of the batch. The lot or control number of the medical gas may be identified by use of a separate identification sticker or decal. (d) Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record. Product labels, including 360° wraparound labels, can be reused provided they meet all applicable labeling requirements, all information on the label is legible, and the label is in good condition. (e) Inspection of the packaging and labeling facilities immediately before use to assure that all medical gases have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records. (f) Bulk or transport containers (as defined in § 201.161(c)(3) of this chapter) are exempt from this section provided they are identified with the name of the product contained therein and accompanied by documentation identifying the product as meeting applicable compendial standards." 21:21:4.0.1.1.13.8.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,H,Subpart H—Holding and Distribution,,§ 213.150 Warehousing and distribution procedures.,FDA,,,,"(a) Written procedures shall be established, and followed, describing the distribution of medical gases and including a system by which the distribution of each lot can be readily determined to facilitate its recall if necessary. (b) Written procedures shall be established, and followed, describing the warehousing of medical gases, including quarantine of such gases before release by the quality unit." 21:21:4.0.1.1.13.9.1.1,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,I,Subpart I—Laboratory Controls,,§ 213.160 General requirements.,FDA,,,,"(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified. (b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, medical gas containers and closures, in-process materials, labeling, and medical gases conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include: (1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, medical gas containers and closures, and labeling used in the manufacture, processing, packing, or holding of a medical gas. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, container, or closure that is subject to deterioration. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for medical gases. Such samples shall be representative and properly identified. (4) The calibration or verification of calibration for instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used." 21:21:4.0.1.1.13.9.1.2,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,I,Subpart I—Laboratory Controls,,§ 213.165 Testing and release for distribution.,FDA,,,,"(a) For each batch of medical gas, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the medical gas, including the identity and strength, prior to release. (b) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling, the number of units per batch to be tested, and acceptance criteria. Such written procedures shall be followed. (c) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 213.194(a)(2). The suitability of all testing methods shall be verified under actual conditions of use. (d) Medical gases failing to meet established standards or specifications and any other relevant quality criteria shall be rejected. (e) This section does not apply to the filling of a designated medical gas or medically appropriate combination of designated medical gases via liquid to liquid into a container at a delivery site." 21:21:4.0.1.1.13.9.1.3,21,Food and Drugs,I,C,213,PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES,I,Subpart I—Laboratory Controls,,"§ 213.166 Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act.",FDA,,,,"(a) For medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act, any stability testing performed and any expiration date established shall be in accordance with paragraph (b) of this section, subject to the conditions established in their approved applications, if any. (b) To assure that the medical gas described in paragraph (a) of this section meets applicable standards of identity, strength, quality, and purity at the time of use: (1) The stability testing program shall be designed to assess the stability characteristics of the medical gas and its container closure system. The results of stability testing shall be used in determining appropriate storage conditions and any expiration date included on the label. The stability program shall include the appropriate sample size, test intervals, container closure systems, and storage conditions for samples retained for testing. (2) Any expiration dates included on the label shall appear in accordance with the requirements of § 201.17 of this chapter. (3) Stability shall be evaluated periodically to ensure that the medical gas continues to meet the standards for identity, strength, quality, and purity stated on the labeling to support the expiration date." 24:24:2.1.1.2.9.1.154.1,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,A,Subpart A—Eligibility Requirements—Projects,,§ 213.1 Eligibility requirements.,HUD,,,"[61 FR 14405, Apr. 1, 1996]","The eligibility requirements set forth in 24 CFR part 200, subpart A, apply to multifamily project mortgages insured under section 213 of the National Housing Act (12 U.S.C. 1715e), as amended." 24:24:2.1.1.2.9.2.154.1,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.251 Cross-reference.,HUD,,,"[36 FR 24553, Dec. 22, 1971, as amended at 37 FR 8662, Apr. 29, 1972]","(a) All of the provisions of subpart B, part 207 of this chapter covering mortgages insured under section 207 of the National Housing Act, apply with full force and effect to mortgages insured under section 213 of the National Housing Act, except the following provisions: Sec. 207.251 Definitions. 207.252 First, second, and third premiums. 207.254 Form of endorsement. Sec. 207.251 Definitions. 207.252 First, second, and third premiums. 207.254 Form of endorsement. (b) For the purposes of this subpart, all references in part 207 of this chapter to section 207 of the National Housing Act shall be deemed to refer to section 213 of the Act, and all references in part 207 of this chapter to the General Insurance Fund shall be deemed to refer to the Cooperative Management Housing Insurance Fund in cases involving mortgages which are the obligation of the Cooperative Management Housing Insurance Fund. (c) The provisions of §§ 207.255, 207.256, 207.257, 207.261, 207.262 and 207.263 of this chapter shall apply to supplementary loans insured under section 213(j) of the Act. In connection with the foregoing provisions the terms mortgagor, mortgagee, mortgage shall be construed to mean borrower, lender, and supplementary loan, including required security instrument. (d) Where the provisions of this subpart are applicable to supplementary loans, the terms mortgagor, mortgagee, mortgage, shall be construed to mean borrower, lender, and supplementary loan, including required security instrument. (e) Where the provisions of this subpart are applicable to operating loss loans, the terms mortgagor, mortgagee and mortgage shall be construed to mean borrower, lender and operating loss loan, including required security instrument, respectively." 24:24:2.1.1.2.9.2.154.10,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.259a Premiums—mortgages insured pursuant to section 238(c) of the Act.,HUD,,,"[42 FR 59675, Nov. 18, 1977]","All of the provisions of §§ 213.253 through 213.259 governing mortgage insurance premiums shall apply to mortgages insured under this subpart pursuant to section 238(c) of the Act, except that all mortgage insurance premiums due on such mortgages in accordance with §§ 213.253 through 213.259 shall be calculated on the basis of one percent." 24:24:2.1.1.2.9.2.154.11,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.260 Allowable methods of premium payment.,HUD,,,,Premiums shall be payable in cash or in debentures at par plus accrued interest. All premiums are payable in advance and no refund can be made of any portion thereof except as hereinafter provided in this part. 24:24:2.1.1.2.9.2.154.12,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.265 Modifications and consolidations.,HUD,,,"[37 FR 8662, Apr. 29, 1972]","Where a mortgage covering an investor sponsored project is modified and consolidated with the mortgage of a purchasing nonprofit cooperative housing corporation or trust, it shall be deemed to be paid in full as of the date of such modification and consolidation." 24:24:2.1.1.2.9.2.154.13,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.266 Initial insurance endorsement.,HUD,,,,The Commissioner shall indicate his insurance of the mortgage or supplementary loan by endorsing the original credit instrument and identifying the section of the Act and the regulations under which the mortgage or supplementary loan is insured and the date of insurance. 24:24:2.1.1.2.9.2.154.14,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.266a Insurance fund obligations.,HUD,,,,"A mortgage endorsed for insurance under section 213 of the Act shall be the obligation either of the Cooperative Management Housing Insurance Fund or of the General Insurance Fund. The determination of the applicable fund shall be governed by the following: (a) A mortgage insured under section 213(a)(1) of the Act or under section 213(a)(3) if the project has been acquired by a cooperative corporation or under section 213 (i) or (j) shall be the obligation of the Cooperative Management Housing Insurance Fund, where it has been insured pursuant to a commitment issued on or after August 10, 1965, or insured pursuant to a commitment issued prior to such date, and transferred to the Cooperative Management Housing Insurance Fund. (b) A mortgage insured under section 213(a)(2) of the Act or under section 213(a)(3) where the project has not been acquired by a cooperative corporation shall be the obligation of the General Insurance Fund. A mortgage insured prior to August 10, 1965, or insured pursuant to a commitment issued prior to such date, where the project has not been transferred to the Cooperative Management Housing Insurance Fund, shall also be the obligation of the General Insurance Fund." 24:24:2.1.1.2.9.2.154.15,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.267 Effect of insurance endorsement.,HUD,,,,"From the date of initial endorsement, the Commissioner and the mortgagee or lender shall be bound by the provisions of this subpart to the same extent as if they had executed a contract including the provisions of this subpart and the applicable sections of the Act." 24:24:2.1.1.2.9.2.154.16,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.268 Final insurance endorsement.,HUD,,,,"When all advances of mortgage or loan proceeds have been made and all the terms and conditions of the commitment have been complied with to the satisfaction of the Commissioner, he shall indicate on the original credit instrument the total of all advances he has approved for insurance and again endorse such instrument." 24:24:2.1.1.2.9.2.154.17,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.269 Endorsement of supplementary loans.,HUD,,,,"The provisions of §§ 213.266, 213.267, and 213.268 shall apply to supplementary loans." 24:24:2.1.1.2.9.2.154.18,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.270 Supplementary loans; election of action; claims; debentures.,HUD,,,,"(a) Election of action. Where a real estate mortgage, deed of trust, conditional sales contract, chattel mortgage, lien, judgement, or any other security device has been used to secure the payment of a loan made under the provisions of this section, the lender may not, except with the approval of the Commissioner, both proceed against such security and also make claim under its contract of insurance, but shall elect which method it desires to pursue. (b) Maximum claim period. Notice of intention to file claim on a form prescribed by the Commissioner shall be filed within 45 days after the lender becomes eligible for the benefits of the loan insurance, or within such later time as may be agreed upon by the Commissioner in writing. (c) Items to be filed on submitting claim. Within 30 days after the filing of the notice of intention to file claim, or within such further period as may be agreed upon by the Commissioner in writing, the lender shall file with the Commissioner: (1) The fiscal data pertaining to the loan transaction; (2) Receipts covering all disbursements as required by the fiscal data form; (3) The original note and any security instrument or instruments which shall be assigned to the Commissioner without recourse or warranty, except that the lender must warrant that no act or omission of the lender has impaired the validity and priority of such security instrument or instruments, that the security instrument or instruments, are prior to all mechanics' and materialmen's liens filed of record subsequent to the recording of such security instrument or instruments regardless of whether such liens attached prior to such recording date, and prior to all liens and encumbrances which may have attached or defects which may have arisen subsequent to the recording of such security instrument or instruments, except such liens or other matters as may be approved by the Commissioner, that the amount stated in the instrument of assignment is actually due and owing under the security instrument or instruments, that there are no offsets or counterclaims thereto, and that the lender has a good right to assign such note and security instrument or instruments; (4) All hazard insurance policies held on property serving as security for the loan or other evidence of insurance coverage acceptable to the Commissioner, together with a copy of the lender's notification to the carrier authorizing the amendment of the loss payable clause substituting the Commissioner as the holder of the security instrument; (5) The assignment to the Commissioner of all rights and interests arising under the note and security instrument or instruments so in default, and all claims of the lender against the borrower or others arising out of the loan transaction; (6) All policies of title or other insurance or surety bonds, or other guarantees and any and all claims thereunder; including evidence satisfactory to the Commissioner that the original title coverage has been extended to include the assignment of the note and the security instrument or instruments to the Commissioner; (7) Any balance of the loan not advanced to the borrower; (8) Any cash or property held by the lender or its agents or to which it is entitled; including deposits made for the account of the borrower and which have not been applied in reduction of the principal obligation under the note and security instrument or instruments; (9) All records, ledger cards, documents, books, papers and accounts relating to the loan transaction; (10) Any additional information or data which the Commissioner may require. (d) Claim computation. Upon an acceptable assignment of the note and security instrument, the Commissioner shall pay the claim of the lender in cash, in debentures or in a combination of both, as determined by the Commissioner at the time of payment. The payment shall be in an amount equal to the unpaid principal balance of the supplementary loan plus: (1) Any accrued interest due on the supplementary loan as of the date of execution of its assignment to the Commissioner; (2) Any advance made previously under the provisions of the loan instrument and approved by the Commissioner; (3) Reimbursement for such reasonable collection costs, court costs, and attorney's fees as may be approved by the Commissioner; (4) An amount equivalent to the debenture interest which would have been earned on the portion of the insurance benefits paid in cash, as of the date such cash payment is made, except that when the lender fails to meet any one of the applicable requirements of paragraphs (b) and (c) of this section within the specified time and in a manner satisfactory to the Commissioner (or within such further time as the Commissioner may approve in writing), the interest allowance in such cash payment shall be computed only to the date on which the particular required action should have been taken or to which it was extended. (e) Debenture interest. The debentures shall bear interest as provided in § 207.259(e)(6) of this chapter. (f) Maturity of debentures. Debentures shall mature 20 years from the date of issue. (g) Registration of debentures. Debentures shall be registered as to principal and interest. (h) Denomination of debentures. Debentures shall be issued in multiples of $50 and any difference not in excess of $50 between the amount of debentures to which the lender is otherwise entitled hereunder and the aggregate face value of the debentures issued shall be paid in cash by the Commissioner to the lender. (i) Redemption of debentures. Debentures shall, at the option of the Commissioner and with the approval of the Secretary of the Treasury, be redeemable at par plus accrued interest on any semiannual interest payment date on 3 months' notice of redemption given in such manner as the Commissioner shall prescribe. The debenture interest on the debentures called for redemption shall cease on the semiannual interest payment date designated in the call notice. The Commissioner may include with the notice of redemption an offer to purchase the debentures at par plus accrued interest at any time during the period between the notice of redemption and the redemption date. If the debentures are purchased by the Commissioner after such call and prior to the named redemption date, the debenture interest shall cease on the date of purchase. (j) Issue date of debentures. The debentures shall be issued as of the date of the execution of the assignment of the supplementary loan in accordance with the requirements of paragraph (c)(3) of this section." 24:24:2.1.1.2.9.2.154.19,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.275 Nature of the Cooperative Management Housing Insurance Fund.,HUD,,,,The Cooperative Management Housing Insurance Fund shall consist of the General Surplus Account and the Participating Reserve Account. 24:24:2.1.1.2.9.2.154.2,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.252 Definitions.,HUD,,,,"The definitions contained in § 213.1 shall apply to this subpart and in addition the following terms shall have the meaning indicated. (a) Contract of Insurance means the agreement evidenced by endorsement of the credit instrument by the Commissioner or his duly authorized representative and includes the terms, conditions and provisions of this subpart and of the National Housing Act. (b) Insured mortgage means a mortgage which has been insured by the endorsement of the credit instrument by the Commissioner. (c) Mortgage means such a first lien upon real estate and other property as is commonly given to secure advances on, or the unpaid purchase price of, real estate under the laws of the State, district or territory in which the real estate is located, together with the credit instrument or instruments, if any, secured thereby. In any instance where an operating loss loan is involved, the term shall include both the original mortgage and the instrument securing the operating loss loan. (d) Mortgagee means the original lender under a mortgage, its successors and such of its assigns as are approved by the Commissioner, and includes the holders of the credit instruments issued under a trust indenture, mortgage or deed of trust pursuant to which such holders act by and through a trustee therein named. (e) Mortgagor means the original borrower under a mortgage and its successors and such of its assigns as are approved by the Commissioner. (f) Project Mortgage means a blanket mortgage insured under section 213 of the Act, covering a group of not less than five single-family dwellings." 24:24:2.1.1.2.9.2.154.20,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.276 Allocation of Cooperative Management Housing Insurance Fund income or losses.,HUD,,,,"For any semiannual period in which Cooperative Management Housing Insurance Fund operations shall result in a net income, or loss, the Commissioner shall allocate such net income or such loss to the General Surplus Account, to the Participating Reserve Account, or to both, as he may determine to be in accordance with sound actuarial and accounting practice. In determining net income or loss, the Commissioner shall take into consideration all income received from fees, premiums, and earnings on investments of the Fund, operating expenses, and provision for losses of the Fund." 24:24:2.1.1.2.9.2.154.21,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.277 Right and liability under the Cooperative Management Housing Insurance Fund.,HUD,,,,No mortgagor or mortgagee shall have any vested right in a credit balance in either the General Surplus Account or the Participating Reserve Account. No mortgagor or mortgagee shall be subject to any liability arising under the mutuality of the Cooperative Management Housing Insurance Fund. 24:24:2.1.1.2.9.2.154.22,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.278 Distribution of distributive share.,HUD,,,,"When the contract of insurance is terminated by reason of payment in full of the mortgage or by voluntary termination approved by the Commissioner, and at such time or times prior to such termination as the Commissioner may approve, the Commissioner may distribute to a mortgagor under a mortgage that is the obligation of the Cooperative Management Housing Insurance Fund a share of the Participating Reserve Account in such manner and amount as he shall determine to be equitable and in accordance with sound actuarial and accounting practice." 24:24:2.1.1.2.9.2.154.23,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.279 Maximum amount of distributive share.,HUD,,,,"In no event shall a distributive share of the Participating Reserve Account exceed the aggregate paid scheduled annual premiums of the mortgagor paid to the year of termination of the insurance or to the year of payment of the share, if paid prior to termination." 24:24:2.1.1.2.9.2.154.24,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.280 Finality of determination.,HUD,,,,The determination of the Commissioner as to the amount to be paid to any mortgagor from the Cooperative Management Housing Insurance Fund shall be final and conclusive. 24:24:2.1.1.2.9.2.154.3,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.253 Premiums upon initial endorsement.,HUD,,,,"(a) Management and Sales Types and Investor Sponsored Projects. The mortgagee, upon the initial endorsement of the mortgage for insurance, shall pay to the Commissioner a first mortgage insurance premium equal to one-half of one percent of the original face amount of the mortgage. (b) Purchasing cooperatives. The provisions of paragraph (a) of this section do not apply to the mortgage or a purchasing nonprofit cooperative housing corporation or trust where such mortgage is endorsed for insurance pursuant to the sale of an Investor Sponsored Project to such purchasing nonprofit cooperative housing corporation or trust. (c) Existing Construction. The provisions of paragraph (a) of the section shall apply to a mortgage covering Existing Construction which involves insurance of advances for Commissioner approved or required repairs, improvements, alterations and additions. (d) Operating loss loans and supplementary loans. The provisions of paragraph (a) of this section shall apply to any operating loss loan and to any supplementary loan, except a supplementary loan to finance the acquisition of an existing community facility." 24:24:2.1.1.2.9.2.154.4,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.254 Premiums where first principal payment more than one year after initial endorsement.,HUD,,,,"(a) Management and Sales Types and Investor Sponsored Projects. (1) If the date of the first principal payment is more than one year following the date of such initial insurance endorsement, the mortgagee, upon the anniversary of such insurance date, shall pay a second premium equal to one-half of one percent of the original face amount of the mortgage. On the date of the first principal payment, the mortgagee shall pay a third premium equal to one-half of one percent of the average outstanding principal obligation of the mortgage for the following year which shall be adjusted so as to accord with such date and so that the aggregate of the first, second and third premiums shall equal the sum of: (i) One percent of the average outstanding principal obligation of the mortgage for the year following the date of initial insurance endorsement, and (ii) One-half of one percent per annum of the average outstanding principal obligation of the mortgage for the period from the first anniversary of the date of initial insurance endorsement to one year following the date of the first principal payment. (2) If the date of the first principal payment of a mortgage is more than one year following the date of the initial insurance endorsement and the mortgage is paid in full prior to the date of such first principal payment, the first and second premiums collected shall be adjusted so that the aggregate of the two premiums shall equal the sum of: (i) One percent of the average outstanding principal obligation of the mortgage for the year following the date of the initial insurance endorsement and (ii) One-half of one percent per annum of the average outstanding principal obligation of the mortgage for the period from the first anniversary of the date of initial endorsement to the date the mortgage was paid in full. (b) Purchasing cooperatives. The provisions of paragraph (a) of this section do not apply to the mortgage of a purchasing nonprofit cooperative housing corporation or trust where such mortgage is endorsed for insurance pursuant to the sale of an Investor Sponsored Project to such purchasing nonprofit cooperative housing corporation or trust. (c) Existing Construction. The provisions of paragraph (a) of this section shall apply to a mortgage covering Existing Construction which involves insurance of advances for Commissioner approved or required repairs, improvements, alterations and additions. (d) Supplementary loan; insurance of advances. The provisions of paragraph (a) shall apply to any supplementary loan involving insurance of advances." 24:24:2.1.1.2.9.2.154.5,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.255 Premiums where first principal payment one year or less after initial endorsement.,HUD,,,,"(a) Management and Sales Types and Investor Sponsored Projects. (1) If the date of the first principal payment is one year, or less than one year following the date of such initial insurance endorsement, the mortgagee, upon such first principal payment date, shall pay a second premium equal to one-half of one percent of the average outstanding principal obligation of the mortgage for the following year which shall be adjusted so as to accord with such date and so that the aggregate of the first and second premiums shall equal the sum of (i) One percent per annum of the average outstanding principal obligation of the mortgage for the period from the date of initial insurance endorsement to the date of first principal payment, and (ii) One-half of one percent of the average outstanding principal obligation of the mortgage for the year following the date of the first principal payment. (2) If the date of the first principal payment of a mortgage is one year or less than one year following the date of the initial insurance endorsement and the mortgage is paid in full prior to the date of such first principal payment, the first and only premium collected shall be adjusted so that the total premium shall equal one percent per annum of the average outstanding principal obligation of the mortgage for the period from the date of initial insurance endorsement to the date the mortgage was paid in full. (b) Purchasing cooperatives. The provisions of paragraph (a) of this section do not apply to the mortgage of a purchasing nonprofit cooperative housing corporation or trust where such mortgage is endorsed for insurance pursuant to the sale of an Investor Sponsored Project to such purchasing nonprofit cooperative housing corporation or trust. (c) Existing Construction. The provisions of paragraph (a) of this section shall apply to a mortgage covering Existing Construction which involves insurance of advances for Commissioner approved or required repairs, improvements, alterations and additions. (d) Supplementary loan; insurance of advances. The provisions of paragraph shall apply to a supplementary loan involving insurance of advances." 24:24:2.1.1.2.9.2.154.6,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.256 Premiums; insurance upon completion.,HUD,,,,"(a) Management and Sales Types and Investor Sponsored Projects. (1) Where the mortgage is initially and finally endorsed for insurance pursuant to a Commitment to Insure Upon Completion, the mortgagee on the date of the first principal payment shall pay a second premium equal to one-half of one percent of the average outstanding principal obligation of the mortgage for the year following such first principal payment date which shall be adjusted so as to accord with such date and so that the aggregate of the first and second premiums shall equal the sum of one-half of one percent per annum of the average outstanding principal obligation of the mortgage for the period from the date of the insurance endorsement to one year following the date of the first principal payment. (2) Where the mortgage is initially and finally endorsed for insurance pursuant to a Commitment to Insure Upon Completion and is paid in full prior to the date of the first principal payment, the first and only premium collected shall be adjusted so that the total premium shall equal one-half of one percent per annum of the average outstanding principal obligation of the mortgage for the period from the date of the insurance endorsement to the date the mortgage was paid in full. (b) Purchasing cooperatives. The provisions of paragraph (a) of this section do not apply to the mortgage of a purchasing nonprofit cooperative housing corporation or trust where such mortgage is endorsed for insurance pursuant to the sale of an Investor Sponsored Project to such purchasing nonprofit cooperative housing corporation or trust. (c) Existing Construction. The provisions of paragraph (a) of this section shall apply to Existing Construction not involving insurance of advances but involved Commissioner approved or required repairs, improvements, alterations and additions. (d) Supplementary loans; Commitment to Insure Upon Completion. The provisions of paragraphs (a) and (b) of this section shall apply to a supplementary loan endorsed for insurance pursuant to a Commitment to Insure Upon Completion." 24:24:2.1.1.2.9.2.154.7,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.257 Premiums; purchasing cooperatives; Existing Construction; supplementary loans to purchase existing community facility.,HUD,,,,"(a) Where a mortgage is endorsed for insurance pursuant to the sale of an Investor Sponsor Project or covers Existing Construction not involving Commissioner approved or required repairs, improvements, alterations and additions, the mortgagee, on the date of the insurance endorsement, shall pay a first premium equal to one-half of one percent of the principal obligation of the mortgage for the period from the date of the insurance endorsement to one year following the date of the first principal payment. On the anniversary of the first principal payment, this first premium shall be adjusted to equal one-half of one percent of the average outstanding principal obligation of the mortgage for the period from the date of the insurance endorsement to one year following the date of the first principal payment. (b) The premium provisions of paragraph (a) of this section shall apply to a supplementary loan to purchase an existing community facility." 24:24:2.1.1.2.9.2.154.8,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.258 Subsequent annual premiums.,HUD,,,,"(a) Until the mortgage is paid in full or until receipt by the Commissioner of an application for insurance benefits, or until the contract of insurance is otherwise terminated with the consent of the Commissioner, the mortgagee, on each anniversary of the date of the first principal payment, shall pay an annual mortgage insurance premium equal to one-half of one percent of the average outstanding principal obligation of the mortgage for the year following the date on which such premium becomes payable. (b) The provisions of paragraph (a) of this section shall apply to operating loss loans and to supplementary loans." 24:24:2.1.1.2.9.2.154.9,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,B,Subpart B—Contract Rights and Obligations—Projects,,§ 213.259 Computation of subsequent annual premiums.,HUD,,,,The premiums payable on and after the date of the first principal payment shall be calculated in accordance with the amortization provisions without taking into account delinquent payments or prepayments. 24:24:2.1.1.2.9.3.155.1,24,Housing and Urban Development,II,B,213,PART 213—COOPERATIVE HOUSING MORTGAGE INSURANCE,C,Subpart C—Individual Properties Released From Project Mortgage; Expiring Program,,§ 213.501 Savings clause.,HUD,,,"[61 FR 60160, Nov. 26, 1996]","No new loans are being insured under the Cooperative Housing Mortgage Insurance Program for individual properties released from a project mortgage. Any existing insured loans on individual properties released from a project mortgage under this program will continue to be governed by the regulations on eligibility requirements, contract rights and obligations, and servicing responsibilities in effect as they existed immediately before December 26, 1996." 49:49:4.1.1.1.8.1.5.1,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.1 Scope of part.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 78 FR 16100, Mar. 13, 2013; 85 FR 63387, Oct. 7, 2020]","(a) This part prescribes minimum safety requirements for railroad track that is part of the general railroad system of transportation. In general, the requirements prescribed in this part apply to specific track conditions existing in isolation. Therefore, a combination of track conditions, none of which individually amounts to a deviation from the requirements in this part, may require remedial action to provide for safe operations over that track. This part does not restrict a railroad from adopting and enforcing additional or more stringent requirements not inconsistent with this part. (b) Subparts A through F apply to track Classes 1 through 5. Subpart G and 213.2, 213.3, 213.15, and 213.240 apply to track over which trains are operated at speeds in excess of those permitted over Class 5 track." 49:49:4.1.1.1.8.1.5.10,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.15 Penalties.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 69 FR 30593, May 28, 2004; 72 FR 51196, Sept. 6, 2007; 73 FR 79701, Dec. 30, 2008; 77 FR 24419, Apr. 24, 2012; 81 FR 43109, July 1, 2016; 82 FR 16132, Apr. 3, 2017; 83 FR 60746, Nov. 27, 2018; 84 FR 23734, May 23, 2019; 84 FR 37072, July 31, 2019; 86 FR 1757, Jan. 11, 2021; 86 FR 23253, May 3, 2021; 87 FR 15867, Mar. 21, 2022; 88 FR 1126, Jan. 6, 2023; 88 FR 89561, Dec. 28, 2023; 89 FR 106295, Dec. 30, 2024; 90 FR 28136, July 1, 2025]","(a) Any person that violates any requirement of this part or causes the violation of any such requirement is subject to a civil penalty of at least the minimum civil monetary penalty and not more than the ordinary maximum civil monetary penalty per violation. However, penalties may be assessed against individuals only for willful violations, and a penalty not to exceed the aggravated maximum civil monetary penalty per violation may be assessed, where: (1) A grossly negligent violation, or a pattern of repeated violations, has created an imminent hazard of death or injury to persons, or (2) A death or injury has occurred. See 49 CFR part 209, appendix A. “Person” means an entity of any type, covered under 49 U.S.C. 21301, including the following: a railroad; a manager, supervisor, official, or other employee or agent of a railroad; any owner, manufacturer, lessor, or lessee of railroad equipment, track, or facilities; any independent contractor providing goods or services to a railroad; any employee of such owner, manufacturer, lessor, lessee, or independent contractor; and anyone held by the Federal Railroad Administrator to be responsible under § 213.5(d) or § 213.303(c). Each day a violation continues shall constitute a separate offense. See FRA's website at https://railroads.dot.gov/ for a statement of agency civil penalty policy. (b) Any person who knowingly and willfully falsifies a record or report required by this part may be subject to criminal penalties under 49 U.S.C. 21311." 49:49:4.1.1.1.8.1.5.11,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.17 Waivers.,FRA,,,,"(a) Any owner of track to which this part applies, or other person subject to this part, may petition the Federal Railroad Administrator for a waiver from any or all requirements prescribed in this part. The filing of such a petition does not affect that person's responsibility for compliance with that requirement while the petition is being considered. (b) Each petition for a waiver under this section shall be filed in the manner and contain the information required by part 211 of this chapter. (c) If the Administrator finds that a waiver is in the public interest and is consistent with railroad safety, the Administrator may grant the exemption subject to any conditions the Administrator deems necessary. Where a waiver is granted, the Administrator publishes a notice containing the reasons for granting the waiver." 49:49:4.1.1.1.8.1.5.12,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.19 Information collection.,FRA,,,,"(a) The information collection requirements of this part were reviewed by the Office of Management and Budget pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) and are assigned OMB control number 2130-0010. (b) The information collection requirements are found in the following sections: §§ 213.4, 213.5, 213.7, 213.17, 213.57, 213.119, 213.122, 213.233, 213.237, 213.241, 213.303, 213.305, 213.317, 213.329, 213.333, 213.339, 213.341, 213.343, 213.345, 213.353, 213.361, 213.369." 49:49:4.1.1.1.8.1.5.2,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.3 Application.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 79 FR 4256, Jan. 24, 2014]","(a) Except as provided in paragraph (b) of this section, this part applies to all standard gage track in the general railroad system of transportation. (b) This part does not apply to track: (1) Located inside an installation that is not part of the general railroad system of transportation (i.e., a plant railroad). As used in this part, a plant railroad means a plant or installation that owns or leases a locomotive, uses that locomotive to switch cars throughout the plant or installation, and is moving goods solely for use in the facility's own industrial processes. The plant or installation could include track immediately adjacent to the plant or installation if the plant railroad leases the track from the general system railroad and the lease provides for (and actual practice entails) the exclusive use of that track by the plant railroad and the general system railroad for purposes of moving only cars shipped to or from the plant. A plant or installation that operates a locomotive to switch or move cars for other entities, even if solely within the confines of the plant or installation, rather than for its own purposes or industrial processes, will not be considered a plant railroad because the performance of such activity makes the operation part of the general railroad system of transportation. Similarly, this exclusion does not apply to track over which a general system railroad operates, even if that track is located within a plant railroad; (2) Used exclusively for tourist, scenic, historic, or excursion operations that are not part of the general railroad system of transportation. As used in this part, tourist, scenic, historic, or excursion operations that are not part of the general railroad system of transportation means a tourist, scenic, historic, or excursion operation conducted only on track used exclusively for that purpose (i.e., there is no freight, intercity passenger, or commuter passenger railroad operation on the track); or (3) Used exclusively for rapid transit operations in an urban area that are not connected to the general railroad system of transportation." 49:49:4.1.1.1.8.1.5.3,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.4 Excepted track.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 90 FR 28136, July 1, 2025]","A track owner may designate a segment of track as excepted track provided that— (a) The segment is identified in the timetable, special instructions, general order, or other appropriate records which are available for inspection during regular business hours; (b) The identified segment is not located within 30 feet of an adjacent track which can be subjected to simultaneous use at speeds in excess of 10 miles per hour; (c) The identified segment is inspected in accordance with 213.233(c) and 213.235 at the frequency specified for Class 1 track; (d) The identified segment of track is not located on a bridge including the track approaching the bridge for 100 feet on either side, or located on a public street or highway, if railroad cars containing commodities required to be placarded by the Hazardous Materials Regulations (49 CFR part 172), are moved over the track; and (e) The railroad conducts operations on the identified segment under the following conditions: (1) No train shall be operated at speeds in excess of 10 miles per hour; (2) No occupied passenger train shall be operated; (3) No freight train shall be operated that contains more than five cars required to be placarded by the Hazardous Materials Regulations (49 CFR part 172); and (4) The gage on excepted track shall not be more than 4 feet 10 1/4 inches. This paragraph (e)(4) is applicable September 21, 1999. (f) A track owner shall advise the Track and Structures Division of FRA's Office of Railroad Safety (Track and Structures Division) at least 10 days prior to removal of a segment of track from excepted status." 49:49:4.1.1.1.8.1.5.4,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.5 Responsibility for compliance.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 85 FR 63387, Oct. 7, 2020; 90 FR 28136, July 1, 2025]","(a) Except as provided in paragraph (b) of this section, any owner of track to which this part applies who knows or has notice that the track does not comply with the requirements of this part, shall— (1) Bring the track into compliance; (2) Halt operations over that track; or (3) Operate under authority of a person designated under § 213.7(a), subject to conditions set forth in this part. If the operation is on continuous welded rail (CWR) track, the person under whose authority operations are conducted must also be designated under § 213.7(c). (b) If an owner of track to which this part applies designates a segment of track as “excepted track” under the provisions of § 213.4, operations may continue over that track without complying with the provisions of subparts B, C, D, and E of this part, unless otherwise expressly stated. (c) If an owner of track to which this part applies assigns responsibility for the track to another person (by lease or otherwise), written notification of the assignment shall be provided to FRA's Track and Structures Division at least 30 days in advance of the assignment. The notification may be made by any party to that assignment, but shall be in writing and include the following— (1) The name and address of the track owner; (2) The name and address of the person to whom responsibility is assigned (assignee); (3) A statement of the exact relationship between the track owner and the assignee; (4) A precise identification of the track; (5) A statement as to the competence and ability of the assignee to carry out the duties of the track owner under this part; and (6) A statement signed by the assignee acknowledging the assignment to him of responsibility for purposes of compliance with this part. (d) The Administrator may hold the track owner or the assignee or both responsible for compliance with this part and subject to penalties under § 213.15. (e) A common carrier by railroad which is directed by the Surface Transportation Board to provide service over the track of another railroad under 49 U.S.C. 11123 is considered the owner of that track for the purposes of the application of this part during the period the directed service order remains in effect. (f) When any person, including a contractor for a railroad or track owner, performs any function required by this part, that person is required to perform that function in accordance with this part." 49:49:4.1.1.1.8.1.5.5,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.7 Designation of qualified persons to supervise certain renewals and inspect track.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 74 FR 43002, Aug. 25, 2009; 78 FR 16100, Mar. 13, 2013; 85 FR 63387, Oct. 7, 2020]","(a) Each track owner to which this part applies shall designate qualified persons to supervise restorations and renewals of track under traffic conditions. Each person designated shall have— (1) At least— (i) 1 year of experience in railroad track maintenance under traffic conditions; or (ii) A combination of experience in track maintenance and training from a course in track maintenance or from a college level educational program related to track maintenance. (2) Demonstrated to the owner that he or she— (i) Knows and understands the requirements of this part that apply to the restoration and renewal of the track for which he or she is responsible; (ii) Can detect deviations from those requirements; and (iii) Can prescribe appropriate remedial action to correct or safely compensate for those deviations; and (3) Authorization from the track owner to prescribe remedial actions to correct or safely compensate for deviations from the requirements of this part. (b) Each track owner to which this part applies shall designate qualified persons to inspect track for defects. Each person designated shall have— (1) At least— (i) 1 year of experience in railroad track inspection; or (ii) A combination of experience in track inspection and training from a course in track inspection or from a college level educational program related to track inspection; (2) Demonstrated to the owner that he or she— (i) Knows and understands the requirements of this part that apply to the inspection of the track for which he or she is responsible; (ii) Can detect deviations from those requirements; and (iii) Can prescribe appropriate remedial action to correct or safely compensate for those deviations; and (3) Authorization from the track owner to prescribe remedial actions to correct or safely compensate for deviations from the requirements of this part, pending review by a qualified person designated under paragraph (a) of this section. (c) Individuals designated under paragraphs (a) or (b) of this section that inspect continuous welded rail (CWR) track or supervise the installation, adjustment, and maintenance of CWR track in accordance with the written procedures of the track owner shall have: (1) Current qualifications under either paragraph (a) or (b) of this section; (2) Successfully completed a comprehensive training course specifically developed for the application of written CWR procedures issued by the track owner; (3) Demonstrated to the track owner that the individual: (i) Knows and understands the requirements of those written CWR procedures; (ii) Can detect deviations from those requirements; and (iii) Can prescribe appropriate remedial action to correct or safely compensate for those deviations; and (4) Authorization from the track owner to prescribe remedial actions to correct or safely compensate from deviation from the requirements in these procedures and successfully completed a recorded examination on those procedures as part of the qualification process. (d) Persons not fully qualified to supervise certain renewals and inspect track as required in paragraphs (a) through (c) of this section, but with at least one year of maintenance-of-way or signal experience, may pass trains over broken rails and pull aparts provided that— (1) The track owner determines the person to be qualified and, as part of doing so, trains, examines, and re-examines the person periodically within two years after each prior examination on the following topics as they relate to the safe passage of trains over broken rails or pull aparts: rail defect identification, crosstie condition, track surface and alinement, gage restraint, rail end mismatch, joint bars, and maximum distance between rail ends over which trains may be allowed to pass. The sole purpose of the examination is to ascertain the person's ability to effectively apply these requirements and the examination may not be used to disqualify the person from other duties. A minimum of four hours training is required for initial training; (2) The person deems it safe and train speeds are limited to a maximum of 10 m.p.h. over the broken rail or pull apart; (3) The person shall watch all movements over the broken rail or pull apart and be prepared to stop the train if necessary; and (4) Person(s) fully qualified under § 213.7 are notified and dispatched to the location promptly for the purpose of authorizing movements and effecting temporary or permanent repairs. (e) With respect to designations under paragraph (a) through (d) of this section, each track owner shall maintain records of— (1) Each designation in effect; (2) The date each designation was made; and (3) The basis for each designation, including the method used to determine that the designated person is qualified. (f) Each track owner shall keep designation records required under paragraph (e) of this section readily available for inspection or copying by the Federal Railroad Administration during regular business hours, following reasonable notice." 49:49:4.1.1.1.8.1.5.6,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.9 Classes of track: operating speed limits.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 85 FR 63388, Oct. 7, 2020]","(a) Except as provided in paragraph (b) of this section and §§ 213.57(b), 213.59(a), 213.113(a), and 213.137(b) and (c), the following maximum allowable operating speeds apply— [In miles per hour] (b) If a segment of track does not meet all of the requirements of its intended class, it is reclassified to the next lowest class of track for which it does meet all of the requirements of this part. However, if the segment of track does not at least meet the requirements of Class 1 track, operations may continue at Class 1 speeds for a period of not more than 30 days without bringing the track into compliance, under the authority of a person designated under § 213.7(a), after that person determines that operations may safely continue and subject to any limiting conditions specified by such person." 49:49:4.1.1.1.8.1.5.7,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.11 Restoration or renewal of track under traffic conditions.,FRA,,,"[85 FR 63388, Oct. 7, 2020]","If during a period of restoration or renewal, track is under traffic conditions and does not meet all of the requirements prescribed in this part, the work on the track shall be under the continuous supervision of a person designated under § 213.7(a) and, as applicable, § 213.7(c). The work on the track shall also be subject to any limiting conditions specified by such person. The operating speed cannot be more than the maximum allowable speed under § 213.9 for the class of track concerned. The term “continuous supervision” as used in this section means the physical presence of that person at the job site. However, since the work may be performed over a large area, it is not necessary that each phase of the work be done under the visual supervision of that person." 49:49:4.1.1.1.8.1.5.8,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.13 Measuring track not under load.,FRA,,,,"When unloaded track is measured to determine compliance with requirements of this part, the amount of rail movement, if any, that occurs while the track is loaded must be added to the measurements of the unloaded track." 49:49:4.1.1.1.8.1.5.9,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,A,Subpart A—General,,§ 213.14 Application of requirements to curved track.,FRA,,,"[78 FR 16100, Mar. 13, 2013]","Unless otherwise provided in this part, requirements specified for curved track apply only to track having a curvature greater than 0.25 degree." 49:49:4.1.1.1.8.2.5.1,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,B,Subpart B—Roadbed,,§ 213.31 Scope.,FRA,,,,This subpart prescribes minimum requirements for roadbed and areas immediately adjacent to roadbed. 49:49:4.1.1.1.8.2.5.2,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,B,Subpart B—Roadbed,,§ 213.33 Drainage.,FRA,,,,"Each drainage or other water carrying facility under or immediately adjacent to the roadbed shall be maintained and kept free of obstruction, to accommodate expected water flow for the area concerned." 49:49:4.1.1.1.8.2.5.3,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,B,Subpart B—Roadbed,,§ 213.37 Vegetation.,FRA,,,,"Vegetation on railroad property which is on or immediately adjacent to roadbed shall be controlled so that it does not— (a) Become a fire hazard to track-carrying structures; (b) Obstruct visibility of railroad signs and signals: (1) Along the right-of-way, and (2) At highway-rail crossings; (This paragraph (b)(2) is applicable September 21, 1999.) (c) Interfere with railroad employees performing normal trackside duties; (d) Prevent proper functioning of signal and communication lines; or (e) Prevent railroad employees from visually inspecting moving equipment from their normal duty stations." 49:49:4.1.1.1.8.3.5.1,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,C,Subpart C—Track Geometry,,§ 213.51 Scope.,FRA,,,,"This subpart prescribes requirements for the gage, alinement, and surface of track, and the elevation of outer rails and speed limitations for curved track." 49:49:4.1.1.1.8.3.5.2,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,C,Subpart C—Track Geometry,,§ 213.53 Gage.,FRA,,,,"(a) Gage is measured between the heads of the rails at right-angles to the rails in a plane five-eighths of an inch below the top of the rail head. (b) Gage shall be within the limits prescribed in the following table—" 49:49:4.1.1.1.8.3.5.3,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,C,Subpart C—Track Geometry,,§ 213.55 Track alinement.,FRA,,,"[78 FR 16100, Mar. 13, 2013]","(a) Except as provided in paragraph (b) of this section, alinement may not deviate from uniformity more than the amount prescribed in the following table: 1 The ends of the line shall be at points on the gage side of the line rail, five-eighths of an inch below the top of the railhead. Either rail may be used as the line rail; however, the same rail shall be used for the full length of that tangential segment of the track. 2 The ends of the chord shall be at points on the gage side of the outer rail, five-eighths of an inch below the top of the railhead. 3 N/A—Not Applicable (b) For operations at a qualified cant deficiency, E u , of more than 5 inches, the alinement of the outside rail of the curve may not deviate from uniformity more than the amount prescribed in the following table: 1 The ends of the chord shall be at points on the gage side of the outer rail, five-eighths of an inch below the top of the railhead. 2 Restraining rails or other systems may be required for derailment prevention. 3 N/A—Not Applicable" 49:49:4.1.1.1.8.3.5.4,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,C,Subpart C—Track Geometry,,§ 213.57 Curves; elevation and speed limitations.,FRA,,,"[78 FR 16101, Mar. 13, 2013]","(a) The maximum elevation of the outside rail of a curve may not be more than 8 inches on track Classes 1 and 2, and 7 inches on track Classes 3 through 5. The outside rail of a curve may not be lower than the inside rail by design, except when engineered to address specific track or operating conditions; the limits in § 213.63 apply in all cases. (b) The maximum allowable posted timetable operating speed for each curve is determined by the following formula— Where— V max = Maximum allowable posted timetable operating speed (m.p.h.). E a = Actual elevation of the outside rail (inches). 1 1 Actual elevation, E a , for each 155-foot track segment in the body of the curve is determined by averaging the elevation for 11 points through the segment at 15.5-foot spacing. If the curve length is less than 155 feet, the points are averaged through the full length of the body of the curve. E u = Qualified cant deficiency 2 (inches) of the vehicle type. 2 If the actual elevation, E a , and degree of curvature, D, change as a result of track degradation, then the actual cant deficiency for the maximum allowable posted timetable operating speed, V max , may be greater than the qualified cant deficiency, E u . This actual cant deficiency for each curve may not exceed the qualified cant deficiency, E u , plus 1 inch. D = Degree of curvature (degrees). 3 3 Degree of curvature, D, is determined by averaging the degree of curvature over the same track segment as the elevation. Where— V max = Maximum allowable posted timetable operating speed (m.p.h.). E a = Actual elevation of the outside rail (inches). 1 1 Actual elevation, E a , for each 155-foot track segment in the body of the curve is determined by averaging the elevation for 11 points through the segment at 15.5-foot spacing. If the curve length is less than 155 feet, the points are averaged through the full length of the body of the curve. E u = Qualified cant deficiency 2 (inches) of the vehicle type. 2 If the actual elevation, E a , and degree of curvature, D, change as a result of track degradation, then the actual cant deficiency for the maximum allowable posted timetable operating speed, V max , may be greater than the qualified cant deficiency, E u . This actual cant deficiency for each curve may not exceed the qualified cant deficiency, E u , plus 1 inch. D = Degree of curvature (degrees). 3 3 Degree of curvature, D, is determined by averaging the degree of curvature over the same track segment as the elevation. (c) All vehicles are considered qualified for operating on track with a cant deficiency, E u , not exceeding 3 inches. Table 1 of appendix A to this part is a table of speeds computed in accordance with the formula in paragraph (b) of this section, when E u equals 3 inches, for various elevations and degrees of curvature. (d) Each vehicle type must be approved by FRA to operate on track with a qualified cant deficiency, E u , greater than 3 inches. Each vehicle type must demonstrate, in a ready-for-service load condition, compliance with the requirements of either paragraph (d)(1) or (2) of this section. (1) When positioned on a track with a uniform superelevation equal to the proposed cant deficiency: (i) No wheel of the vehicle type unloads to a value less than 60 percent of its static value on perfectly level track; and (ii) For passenger cars, the roll angle between the floor of the equipment and the horizontal does not exceed 8.6 degrees; or (2) When operating through a constant radius curve at a constant speed corresponding to the proposed cant deficiency, and a test plan is submitted to and approved by FRA in accordance with § 213.345(e) and (f): (i) The steady-state (average) load on any wheel, throughout the body of the curve, is not less than 60 percent of its static value on perfectly level track; and (ii) For passenger cars, the steady-state (average) lateral acceleration measured on the floor of the carbody does not exceed 0.15g. (e) The track owner or railroad shall transmit the results of the testing specified in paragraph (d) of this section to FRA's Associate Administrator for Railroad Safety/Chief Safety Officer (FRA) requesting approval for the vehicle type to operate at the desired curving speeds allowed under the formula in paragraph (b) of this section. The request shall be made in writing and contain, at a minimum, the following information— (1) A description of the vehicle type involved, including schematic diagrams of the suspension system(s) and the estimated location of the center of gravity above top of rail; (2) The test procedure, 4 including the load condition under which the testing was performed, and description of the instrumentation used to qualify the vehicle type, as well as the maximum values for wheel unloading and roll angles or accelerations that were observed during testing; and 4 The test procedure may be conducted whereby all the wheels on one side (right or left) of the vehicle are raised to the proposed cant deficiency, the vertical wheel loads under each wheel are measured, and a level is used to record the angle through which the floor of the vehicle has been rotated. (3) For vehicle types not subject to parts 229 or 238 of this chapter, procedures or standards in effect that relate to the maintenance of all safety-critical components of the suspension system(s) for the particular vehicle type. Safety-critical components of the suspension system are those that impact or have significant influence on the roll of the carbody and the distribution of weight on the wheels. (f) In approving the request made pursuant to paragraph (e) of this section, FRA may impose conditions necessary for safely operating at the higher curving speeds. Upon FRA approval of the request, the track owner or railroad shall notify FRA in writing no less than 30 calendar days prior to the proposed implementation of the approved higher curving speeds allowed under the formula in paragraph (b) of this section. The notification shall contain, at a minimum, identification of the track segment(s) on which the higher curving speeds are to be implemented. (g) The documents required by this section must be provided to FRA by: (1) The track owner; or (2) A railroad that provides service with the same vehicle type over trackage of one or more track owner(s), with the written consent of each affected track owner. (h)(1) Vehicle types permitted by FRA to operate at cant deficiencies, E u , greater than 3 inches but not more than 5 inches shall be considered qualified under this section to operate at those permitted cant deficiencies for any track segment. The track owner or railroad shall notify FRA in writing no less than 30 calendar days prior to the proposed implementation of such curving speeds in accordance with paragraph (f) of this section. (2) Vehicle types permitted by FRA to operate at cant deficiencies, E u , greater than 5 inches shall be considered qualified under this section to operate at those permitted cant deficiencies only for the previously operated or identified track segments(s). (i) For vehicle types intended to operate at any curving speed producing more than 5 inches of cant deficiency, the following provisions of subpart G of this part shall apply: §§ 213.333(a) through (g), (j)(1), (k) and (m), 213.345, and 213.369(f). (j) As used in this section— (1) Vehicle means a locomotive, as defined in § 229.5 of this chapter; a freight car, as defined in § 215.5 of this chapter; a passenger car, as defined in § 238.5 of this chapter; and any rail rolling equipment used in a train with either a freight car or a passenger car. (2) Vehicle type means like vehicles with variations in their physical properties, such as suspension, mass, interior arrangements, and dimensions that do not result in significant changes to their dynamic characteristics." 49:49:4.1.1.1.8.3.5.5,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,C,Subpart C—Track Geometry,,§ 213.59 Elevation of curved track; runoff.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 78 FR 16101, Mar. 13, 2013]","(a) If a curve is elevated, the full elevation shall be provided throughout the curve, unless physical conditions do not permit. If elevation runoff occurs in a curve, the actual minimum elevation shall be used in computing the maximum allowable posted timetable operating speed for that curve under § 213.57(b). (b) Elevation runoff shall be at a uniform rate, within the limits of track surface deviation prescribed in § 213.63, and it shall extend at least the full length of the spirals. If physical conditions do not permit a spiral long enough to accommodate the minimum length of runoff, part of the runoff may be on tangent track." 49:49:4.1.1.1.8.3.5.6,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,C,Subpart C—Track Geometry,,§ 213.63 Track surface.,FRA,,,"[78 FR 16101, Mar. 13, 2013]","(a) Except as provided in paragraph (b) of this section, each track owner shall maintain the surface of its track within the limits prescribed in the following table: 1 Except as limited by § 213.57(a), where the elevation at any point in a curve equals or exceeds 6 inches, the difference in crosslevel within 62 feet between that point and a point with greater elevation may not be more than 1 1/2 inches. 2 However, to control harmonics on Class 2 through 5 jointed track with staggered joints, the crosslevel differences shall not exceed 1 1/4 inches in all of six consecutive pairs of joints, as created by seven low joints. Track with joints staggered less than 10 feet apart shall not be considered as having staggered joints. Joints within the seven low joints outside of the regular joint spacing shall not be considered as joints for purposes of this footnote. (b) For operations at a qualified cant deficiency, E u , of more than 5 inches, each track owner shall maintain the surface of the curve within the limits prescribed in the following table: 1 N/A—Not Applicable." 49:49:4.1.1.1.8.3.5.7,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,C,Subpart C—Track Geometry,,§ 213.65 Combined track alinement and surface deviations.,FRA,,,"[78 FR 16102, Mar. 13, 2013]","On any curved track where operations are conducted at a qualified cant deficiency, E u , greater than 5 inches, the combination of alinement and surface deviations for the same chord length on the outside rail in the curve, as measured by a TGMS, shall comply with the following formula: Where— A m = measured alinement deviation from uniformity (outward is positive, inward is negative). A L = allowable alinement limit as per § 213.55(b) (always positive) for the class of track. S m = measured profile deviation from uniformity (down is positive, up is negative). S L = allowable profile limit as per § 213.63(b) (always positive) for the class of track. Where— A m = measured alinement deviation from uniformity (outward is positive, inward is negative). A L = allowable alinement limit as per § 213.55(b) (always positive) for the class of track. S m = measured profile deviation from uniformity (down is positive, up is negative). S L = allowable profile limit as per § 213.63(b) (always positive) for the class of track." 49:49:4.1.1.1.8.4.5.1,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.101 Scope.,FRA,,,,"This subpart prescribes minimum requirements for ballast, crossties, track assembly fittings, and the physical conditions of rails." 49:49:4.1.1.1.8.4.5.10,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.122 Torch cut rail.,FRA,,,,"(a) Except as a temporary repair in emergency situations no rail having a torch cut end shall be used in Classes 3 through 5 track. When a rail end is torch cut in emergency situations, train speed over that rail end shall not exceed the maximum allowable for Class 2 track. For existing torch cut rail ends in Classes 3 through 5 track the following shall apply— (1) Within one year of September 21, 1998, all torch cut rail ends in Class 5 track shall be removed; (2) Within two years of September 21, 1998, all torch cut rail ends in Class 4 track shall be removed; and (3) Within one year of September 21, 1998, all torch cut rail ends in Class 3 track over which regularly scheduled passenger trains operate, shall be inventoried by the track owner. (b) Following the expiration of the time limits specified in paragraphs (a)(1), (2), and (3) of this section, any torch cut rail end not removed from Classes 4 and 5 track, or any torch cut rail end not inventoried in Class 3 track over which regularly scheduled passenger trains operate, shall be removed within 30 days of discovery. Train speed over that rail end shall not exceed the maximum allowable for Class 2 track until removed." 49:49:4.1.1.1.8.4.5.11,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.123 Tie plates.,FRA,,,,"(a) In Classes 3 through 5 track where timber crossties are in use there shall be tie plates under the running rails on at least eight of any 10 consecutive ties. (b) In Classes 3 through 5 track no metal object which causes a concentrated load by solely supporting a rail shall be allowed between the base of the rail and the bearing surface of the tie plate. This paragraph (b) is applicable September 21, 1999.)" 49:49:4.1.1.1.8.4.5.12,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.127 Rail fastening systems.,FRA,,,"[76 FR 18086, Apr. 1, 2011]","(a) Track shall be fastened by a system of components that effectively maintains gage within the limits prescribed in § 213.53(b). Each component of each such system shall be evaluated to determine whether gage is effectively being maintained. (b) If rail anchors are applied to concrete crossties, the combination of the crossties, fasteners, and rail anchors must provide effective longitudinal restraint. (c) Where fastener placement impedes insulated joints from performing as intended, the fastener may be modified or removed, provided that the crosstie supports the rail." 49:49:4.1.1.1.8.4.5.13,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.133 Turnouts and track crossings generally.,FRA,,,,"(a) In turnouts and track crossings, the fastenings shall be intact and maintained so as to keep the components securely in place. Also, each switch, frog, and guard rail shall be kept free of obstructions that may interfere with the passage of wheels. (b) Classes 3 through 5 track shall be equipped with rail anchoring through and on each side of track crossings and turnouts, to restrain rail movement affecting the position of switch points and frogs. For Class 3 track, this paragraph (b) is applicable September 21, 1999.) (c) Each flangeway at turnouts and track crossings shall be at least 1 1/2 inches wide." 49:49:4.1.1.1.8.4.5.14,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.135 Switches.,FRA,,,,"(a) Each stock rail must be securely seated in switch plates, but care shall be used to avoid canting the rail by overtightening the rail braces. (b) Each switch point shall fit its stock rail properly, with the switch stand in either of its closed positions to allow wheels to pass the switch point. Lateral and vertical movement of a stock rail in the switch plates or of a switch plate on a tie shall not adversely affect the fit of the switch point to the stock rail. Broken or cracked switch point rails will be subject to the requirements of § 213.113, except that where remedial actions C, D, or E require the use of joint bars, and joint bars cannot be placed due to the physical configuration of the switch, remedial action B will govern, taking into account any added safety provided by the presence of reinforcing bars on the switch points. (c) Each switch shall be maintained so that the outer edge of the wheel tread cannot contact the gage side of the stock rail. (d) The heel of each switch rail shall be secure and the bolts in each heel shall be kept tight. (e) Each switch stand and connecting rod shall be securely fastened and operable without excessive lost motion. (f) Each throw lever shall be maintained so that it cannot be operated with the lock or keeper in place. (g) Each switch position indicator shall be clearly visible at all times. (h) Unusually chipped or worn switch points shall be repaired or replaced. Metal flow shall be removed to insure proper closure. (i) Tongue & Plain Mate switches, which by design exceed Class 1 and excepted track maximum gage limits, are permitted in Class 1 and excepted track." 49:49:4.1.1.1.8.4.5.15,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.137 Frogs.,FRA,,,"[63 FR 34029, June 22, 1998, as amended at 85 FR 63388, Oct. 7, 2020]","(a) Except as provided in paragraph (e) of this section, the flangeway depth measured from a plane across the wheel-bearing area of a frog on Class 1 track shall not be less than 1 3/8 inches, or less than 1 1/2 inches on Classes 2 through 5 track. (b) If a frog point is chipped, broken, or worn more than five-eighths inch down and 6 inches back, operating speed over the frog shall not be more than 10 m.p.h. (c) If the tread portion of a frog casting is worn down more than three-eighths inch below the original contour, operating speed over that frog shall not be more than 10 m.p.h. (d) Where frogs are designed as flange-bearing, flangeway depth may be less than that shown for Class 1 if operated at Class 1 speeds. (e) The flange depth requirements in paragraph (a) do not apply to a frog designed as a flange-bearing frog (FBF) used in a crossing diamond in Classes 2 through 5 track, provided that the crossing angle is greater than 20 degrees unless movable guard rails are used." 49:49:4.1.1.1.8.4.5.16,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.139 Spring rail frogs.,FRA,,,,"(a) The outer edge of a wheel tread shall not contact the gage side of a spring wing rail. (b) The toe of each wing rail shall be solidly tamped and fully and tightly bolted. (c) Each frog with a bolt hole defect or head-web separation shall be replaced. (d) Each spring shall have compression sufficient to hold the wing rail against the point rail. (e) The clearance between the holddown housing and the horn shall not be more than one-fourth of an inch." 49:49:4.1.1.1.8.4.5.17,49,Transportation,II,,213,PART 213—TRACK SAFETY STANDARDS,D,Subpart D—Track Structure,,§ 213.141 Self-guarded frogs.,FRA,,,,"(a) The raised guard on a self-guarded frog shall not be worn more than three-eighths of an inch. (b) If repairs are made to a self-guarded frog without removing it from service, the guarding face shall be restored before rebuilding the point."