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| 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 |
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| 20:20:1.0.2.9.43.0.155.1 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.1 Introduction. | SSA | [56 FR 65679, Dec. 18, 1991] | This part explains which units of the Board are authorized to make initial determinations with respect to entitlement to benefits under the Railroad Unemployment Insurance Act and waiver of recovery of overpayments under that Act. This part explains how notice of such determinations is to be communicated to the claimant and to his or her base-year employer(s) and how these determinations may be appealed. | |||||
| 20:20:1.0.2.9.43.0.155.10 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.18 Hearings officer. | SSA | [56 FR 65680, Dec. 18, 1991] | Within a reasonable time after a party has filed a properly executed appeal, the Director of Hearings and Appeals shall appoint a hearings officer to act in the appeal. Such hearings officer shall not have any interest in the parties or in the outcome of the proceeding, shall not have directly participated in the initial determination from which the appeal is made, and shall not have any other interest in the matter which might prevent a fair and impartial hearing. In any case in which employee status or creditability of compensation is an issue, the hearings officer shall receive evidence and report to the Board thereon with recommendations. In all other cases, the hearings officer shall consider and decide the appeal; in each such case where the hearings officer determines that an issue of fact exists, the parties shall have the right to a hearing. | |||||
| 20:20:1.0.2.9.43.0.155.11 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.19 Election to participate. | SSA | [56 FR 65680, Dec. 18, 1991] | (a) Claimant files an appeal. Where the claimant has filed an appeal under § 320.12 of this part the hearings officer shall notify the claimant's base-year employer(s) that such an appeal has been filed and shall provide the base-year employer with a statement of issues on appeal. The hearings officer shall inform the base-year employer(s) that such employer(s) shall have a right to be present at any hearing which is to be held under this part and the right to submit evidence with respect to the issues on appeal. Within 30 days of the date of such notice a base-year employer shall provide the hearings officer with a statement in writing which summarizes the evidence which such employer intends to present with respect to the issues on appeal, which indicates whether the employer wishes to be present at any hearing which may be held, and which designates who will represent the employer with respect to the appeal. An employer who fails to respond in the time prescribed shall be barred from further participation in the appeal and shall forfeit any further right to review as provided for in this part. (b) Base-year employer files an appeal. Where a base-year employer files an appeal under § 320.12 of this part, the hearings officer shall notify the claimant that such an appeal has been filed and shall provide the claimant with a statement of issues on appeal. The hearings officer shall inform the claimant that he or she or a duly authorized representative shall have a right to be present at any hearing which is to be held under this part and the right to submit evidence with respect to the issues on appeal. Within 30 days of the date of such notice the claimant shall file with the hearings officer an election to participate in the appeal. A claimant who fails to file an election in the time prescribed shall be barred from further participation in the appeal and shall forfeit any right of review as provided for in this part. | |||||
| 20:20:1.0.2.9.43.0.155.12 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.20 Powers of hearings officer. | SSA | In the development of an appeal, the hearings officer shall have the power to hold hearings, require and compel the attendance of witnesses, administer oaths, take testimony, and make all necessary investigations. | ||||||
| 20:20:1.0.2.9.43.0.155.13 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.22 Notice of hearing. | SSA | [53 FR 2488, Jan. 28, 1988, as amended at 71 FR 55283, Sept. 22, 2006] | (a) Notification of parties. At the discretion of the hearings officer, any hearing required under this part may be held in person, by telephone conference call, or by video teleconferencing as described in § 320.25(d). The hearings officer shall promptly notify the party or parties to the proceeding by mail as to said time and place for the hearing. The notice shall include a statement of the specific issues involved in the case. The hearings officer shall make every effort to hold the hearing within 150 days after the date the appeal is filed. (b) Notice of objection. A party to the proceeding may object to the time and place of the hearing, or as to the stated issues to be resolved, by filing a written notice of objection with the hearings officer. The notice of objection shall clearly set forth the matter objected to and the reasons for such objection, and, if the matter objected to is the time and place of the hearing, said notice shall further state that party's choice as to the time and place for the hearing. Said notice of objection shall be filed at the earliest practicable time, but in no event shall said notice be filed later than five business days prior to the scheduled date of the hearing. (c) Ruling on objection. The hearings officer shall rule on any objection timely filed by a party under this section and shall notify the party of his or her ruling thereon. The hearings officer may for good cause shown, or upon his or her own motion, reschedule the time and/or place of the hearing. If an individual objects to having a hearing by video teleconferencing, the hearings officer will find the individual's wish not to appear by video teleconferencing to be a good reason for changing the time or place of the scheduled hearing and will reschedule the hearing for a time or place where a telephone conference call or an in person hearing will be held. The hearings officer also may limit or expand the issues to be resolved at the hearing. (d) Failure to appear or to file objection. If neither a par… | |||||
| 20:20:1.0.2.9.43.0.155.14 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.25 Hearing of appeal. | SSA | [Board Order 58-142, 23 FR 9090, Nov. 22, 1958, as amended at 56 FR 65681, Dec. 18, 1991; 67 FR 77157, Dec. 17, 2002; 71 FR 55284, Sept. 22, 2006] | (a) Manner of conducting hearing. The hearing shall be informal, fair, and impartial, and shall be conducted in such manner as to ascertain the substantial rights of the parties. The hearing shall not be open to the public. (b) Evidence presented in support of appeal. (1) Any party, or his or her representative, shall be afforded full opportunity to present evidence upon any controversial question of fact, orally or in writing or by means of exhibits; to examine and cross-examine witnesses; and to present argument in support of the appeal. (2) The formal rules of evidence shall not apply; however, the hearings officer may exclude evidence which he or she finds is irrelevant or repetitious. Any evidence excluded by the hearings officer shall be described and that description made part of the record. (3) If, in the judgment of the hearings officer, evidence not offered is available and is relevant and material to the merits of the claim, the hearings officer may obtain such evidence upon his or her own initiative. If new evidence is obtained after an oral hearing, other than evidence submitted by a party or his representative, the hearings officer shall provide the parties or their representatives with a copy of such evidence. In such event, any party shall have 30 days to submit rebuttal evidence or argument or to request a supplemental hearing to confront and challenge such new evidence. Any party may move for an extension of time to submit rebuttal evidence or argument and the hearings officer may grant the motion upon a showing of good cause. (c) Where no oral hearing required. Where the hearings officer finds that no factual issues are presented by an appeal, and the only issues raised by the parties are issues concerning the application or interpretation of law, the parties or their representatives shall be afforded full opportunity to submit written argument in support of their position but no oral hearing shall be held. (d) Hearing by telephone or video teleconferencing. As stated in § 320.22(a… | |||||
| 20:20:1.0.2.9.43.0.155.15 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.28 Record of evidence considered. | SSA | [67 FR 77157, Dec. 17, 2002] | The hearings officer will make a record of the material evidence. The record will include the applications, written statements, reports, and other documents that were used in making the determination under review and any other additional evidence the appellant or any other party to the hearing presents in writing. If a hearing was held in the appeal, the tape recording of the hearing will be part of the record while the appeal is pending. The hearings officer's decision will be based on the record. The entire record at any time during the pendency of the appeal shall be available for examination by any party or by his or her duly authorized representative. | |||||
| 20:20:1.0.2.9.43.0.155.16 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.30 Decision or report of hearings officer. | SSA | [Board Order 66-84, 31 FR 10181, July 28, 1966, as amended at 56 FR 65681, Dec. 18, 1991] | As soon as practicable after the completion of the record, the hearings officer shall render his decision, or submit his report to the Board, as may be appropriate in the case. The decision or report shall be based on the record and shall be in writing. Such decision shall contain a brief statement of (a) the issue or issues raised, (b) the evidence submitted, (c) findings of fact, (d) the decision made, and (e) the reasons therefor. Such report shall contain a statement of (1) the issue or issues raised, (2) the evidence submitted, (3) findings of fact, (4) conclusions of law, (5) recommendations as to the decision to be made by the Board, and (6) such discussion of the foregoing as the hearings officer may desire to present to the Board. Within 15 days after rendition of the decision or submission of the report, a copy of the decision or report shall be mailed to each party at the last address of record. In the case of a report, a copy of the transcript of the hearing, if any was held, shall also be mailed to each party. | |||||
| 20:20:1.0.2.9.43.0.155.17 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.32 Effect of decision of hearings officer. | SSA | [56 FR 65681, Dec. 18, 1991] | A decision of the hearings officer, subject to review as hereinafter provided, shall be binding upon any adjudicating office and upon all parties; (a) With respect to the initial determination involved, and (b) With respect to other initial determinations, irrespective of whether they have been appealed, which involved the same parties and which were based upon the same issue or issues determined in the decision of the hearings officer. | |||||
| 20:20:1.0.2.9.43.0.155.18 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.35 Review of decision of hearings officer on motion of Board. | SSA | The Board may, on its own motion, review a decision of the hearings officer on the basis of the evidence previously submitted in the case, and may designate any employee of the Board to take additional evidence and to report his findings to the Board. | ||||||
| 20:20:1.0.2.9.43.0.155.19 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.38 Appeal to Board from decision of hearings officer. | SSA | [56 FR 65681, Dec. 18, 1991] | Any claimant aggrieved by a decision of the hearings officer and any base-year employer(s) whose employee was awarded benefits, who participated in the appeal before the hearings officer, may appeal to the Board for review of the decision. | |||||
| 20:20:1.0.2.9.43.0.155.2 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.2 Definitions. | SSA | [56 FR 65679, Dec. 18, 1991] | As used in this part— Base-year employer means the railroad employer(s) for whom a claimant worked and earned compensation creditable under the Railroad Unemployment Insurance Act during the base year. The base year is the calendar year immediately preceding the benefit year for which a claim is being filed. A benefit year is generally the period July 1 through the following June 30. Party means the claimant, the base-year employer(s), or any person so designated under this part. | |||||
| 20:20:1.0.2.9.43.0.155.20 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.39 Execution and filing of appeal to Board from decision of hearings officer. | SSA | [67 FR 77157, Dec. 17, 2002; 68 FR 6820, Feb. 11, 2003] | (a) An appeal to the Board from the decision of a hearings officer shall be filed on the form provided by the Board and shall be executed in accordance with the instructions on the form. Such appeal shall be filed within 60 days from the date upon which notice of the decision of the hearings officer was mailed to the parties. The right to further review of a decision of a hearings officer shall be forfeited unless formal final appeal is filed in the manner and within the time prescribed in this section. Any written request stating an intent to appeal which is received within the 60-day period will protect the claimant's right to appeal, Provided that the claimant files the appeal form within the later of the 60-day period following the date of the hearing officer's decision, or the 30-day period following the date of the letter sending the appeal form to the claimant. However, when a party fails to file an appeal before the Board within the time prescribed in this section, the Board may waive this requirement if along with the final appeal, the party in writing requests an extension of time. The request for an extension of time must give the reasons why the final appeal form was not filed within the time limit prescribed in this section. If in the judgment of the Board the reasons given establish that the party has good cause for not filing the final appeal form within the time limit prescribed, the Board will consider the appeal to have been filed in a timely manner. The Board will use the standards found in § 320.10(e) of this part in determining if good cause exists. (b) Where a timely appeal seeking waiver of recovery of an erroneous payment has been filed with the three-member Board, the Board shall not commence recovery of the erroneous payment by suspension or reduction of a monthly benefit payable by the Board until a decision with respect to such appeal seeking waiver has been made and notice thereof has been mailed to the claimant. | |||||
| 20:20:1.0.2.9.43.0.155.21 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.40 Procedure before the Board on appeal from a decision of a hearings officer. | SSA | [56 FR 65681, Dec. 18, 1991, as amended at 67 FR 77158, Dec. 17, 2002] | Upon the filing of an appeal to the Board from a decision of a hearings officer, the Secretary to the Board shall notify all parties to the decision of the hearings officer that an appeal has been filed. The parties shall not have the right to submit additional evidence, except that: (a) The Board may permit the submission of additional evidence upon a showing by a party that he or she has additional evidence to present which, for valid reasons, he or she was unable to present at an earlier stage; (b) The Board may request the submission of additional evidence; and (c) The Board may designate any employee of the Board to take additional evidence and to report his or her findings to the Board. Any such additional evidence shall be submitted in such manner as the Board may indicate and shall be included in the record. (d) Any party may submit additional argument in writing with the appeal to the Board. No party shall have the right to an oral presentation before the Board except where the Board so permits. Such presentation may be limited in form, subject matter, length, and time as the Board may indicate to the parties. | |||||
| 20:20:1.0.2.9.43.0.155.22 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.41 Procedure before Board after submission of report by hearings officer. | SSA | (a) After submission to the Board of a hearings officer's report, in an appeal involving employee status or the creditability of compensation, any party to the proceeding may, within twenty days after the mailing to him of a copy of the report, file with the Board and serve upon other parties by mailing to their last addresses of record such exceptions in writing as he desires to make to the hearings officer's findings of fact and conclusions of law. Each exception shall specifically designate the particular finding of fact or conclusion of law to which exception is taken, and shall set forth in detail the grounds of the exception. General exceptions and exceptions not specifically directed to particular findings of fact or conclusions of law will not be considered. Each party shall have ten days after the receipt of exceptions taken by other parties in which to file with the Board replies to the exceptions. The Board may, upon the application of any party and for cause shown, extend the time for filing and serving of exceptions or filing of replies thereto. The hearings officer's report shall be advisory but shall be presumed to be correct. Findings of fact to which no exceptions are taken will, subject only to the power of the Board to reject or modify, stand confirmed. (b) Further argument will not be permitted except upon a showing by any party that he has arguments to present which for valid reasons he was unable to present at an earlier stage, and in cases in which the Board requests further elaboration of arguments. In such cases, the further argument shall be submitted orally or in writing, as the Board may indicate in each case, and shall be subject to such restrictions as to form, subject matter, length, and time as the Board may indicate. | ||||||
| 20:20:1.0.2.9.43.0.155.23 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.42 Decision of Board. | SSA | [Board Order 66-84, 31 FR 10181, July 28, 1966, as amended at 56 FR 65681, Dec. 18, 1991] | The decision of the Board, whether on an appeal to the Board from a decision of a hearings officer, or after submission of a report by a hearings officer, shall be made upon the basis of the record established in accordance with the foregoing sections. Notice of such decision, together with the Board's findings of fact and conclusions of law in connection therewith, shall, within 15 days from the date on which the decision is made, be mailed to the parties at the latest addresses furnished by them. Subject only to judicial review in accordance with § 320.45, the decision of the Board shall be final and conclusive for all purposes: (a) With respect to the initial determination involved, and (b) With respect to other initial determinations, irrespective of whether they have been appealed, which involve the same parties and which were based on the same issue or issues determined in the decision of the Board. In a case in which there has been a hearings officer's report, in an appeal involving employee status or the creditability of compensation, the decision of the Board on all issues determined in such decision shall be final and conclusively establish all rights and obligations, arising under the Act, of every party notified as hereinabove provided of his or her right to participate in the proceedings. | |||||
| 20:20:1.0.2.9.43.0.155.24 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.45 Judicial review. | SSA | [Board Order 58-142, 23 FR 9090, Nov. 22, 1958, as amended at 56 FR 65682, Dec. 18, 1991] | Upon being notified of a decision of the Board made (a) upon review, on the Board's own motion, of a decision of a hearings officer, or (b) upon an appeal to the Board, an aggrieved party may obtain judicial review of such final decision, by filing a petition for review within ninety days after the date on which notice of such decision was mailed to him, or within such further time as the Board may allow, in the U.S. Court of Appeals for the circuit in which the party resides or will have had his principal place of business or principal executive office, or in the U.S. Court of Appeals for the Seventh Circuit or in the Court of Appeals for the District of Columbia. | |||||
| 20:20:1.0.2.9.43.0.155.25 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.48 Representatives of parties. | SSA | In the event a party to any proceeding within the Board, under the preceding regulations in this part, desires to be represented by another person, he shall file with the Board prior to the time of such representation a power of attorney signed by him and naming such other person as the person authorized to represent him: Provided, however, That without requiring such power of attorney the Board may recognize as the duly authorized representative of the claimant the person designated by the claimant's railway labor organization to act in behalf of members of that organization on such matters whenever such representative acts or appears for such claimant. | ||||||
| 20:20:1.0.2.9.43.0.155.26 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.49 Determination of date of filing. | SSA | [67 FR 77158, Dec. 17, 2002] | (a) General rule. Except as otherwise provided in paragraph (b) of this section, for purposes of this part, a document or form is filed on the day it is received by an office of the Board or by an employee of the Board who is authorized to receive it at a place other than one of the Board's offices. (b) Other dates of filing. The Board will also accept as the date of filing the date a document or form is mailed to the Board by the United States mail, if using the date the Board receives it would result in the loss or lessening of rights. The date shown by a U.S. postmark will be used as the date of mailing. If the postmark is unreadable, or there is no postmark, the Board will consider other evidence of when the document or form was mailed to the Board. (c) Use of electronic mail. By agreement between a base-year employer and the Board, any document required to be filed with the Board or any notice required to be sent to the employer may be transmitted by electronic mail. | |||||
| 20:20:1.0.2.9.43.0.155.3 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.5 Initial determinations. | SSA | [56 FR 65679, Dec. 18, 1991, as amended at 77156, Dec. 17, 2002] | An initial determination shall be made with respect to each claim for unemployment or sickness benefits by the appropriate adjudicating office as provided by § 320.6 of this part. Prior to making an initial determination the Board shall provide the claimant's base-year employer(s) and most recent employer if different with notice that a claim has been filed and that the employer(s) has an opportunity to submit information which may be pertinent to the adjudication of the claim. The adjudicating office shall make its determination on the basis of the claimant's application and claim and any relevant information or evidence including any information received from the base-year employer(s). A determination allowing payment of an initial claim shall not establish a presumption that benefits for subsequent claims in the same period of unemployment or sickness are also payable. The Director of Policy and Systems shall issue instructions with respect to the adjudication of claims and initial determination on such claims. If it is found that only part of the benefits claimed may initially be paid, a partial payment shall be made prior to a final decision on the whole claim. | |||||
| 20:20:1.0.2.9.43.0.155.4 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.6 Adjudicating office. | SSA | [53 FR 2486, Jan. 28, 1988, as amended at 60 FR 28534, June 1, 1995; 67 FR 77156, Dec. 17, 2002; 80 FR 13764, Mar. 17, 2015] | (a) The term “adjudicating office” means any subordinate office of the Board which is authorized to make initial determinations and reconsideration decisions with respect to claims for benefits. The following paragraphs state which offices of the Board are adjudicating offices and define their authority to make determinations or decisions. (b) Field offices. Field offices are authorized to make initial determinations on the following issues relating to eligibility for unemployment or sickness benefits, as the case may be: (1) Availability for work; (2) Voluntary leaving of work, with or without good cause; (3) Failure to accept work or apply for work or failure to report to an employment office; (4) Timely registration for unemployment benefits under § 325.2 of this chapter and timely filing of claims for sickness benefits under § 335.4(c) of this chapter; (5) Receipt of remuneration for claimed days of unemployment or sickness, as the case may be; (6) Mileage or work restrictions and stand-by or lay-over rules; (7) Whether the claimant's unemployment is due to a strike. (8) Whether a claimant's earnings attributable to days in a period for which he or she has registered for unemployment benefits exceed the amount of the applicable monthly compensation base. (c) Field Service-Headquarters. Field Service-Headquarters staff are authorized to make determinations on any of the issues listed in paragraph (b) of this section. In addition, Field Service-Headquarters staff are authorized to make initial determinations on the following issues: (1) Erroneous payment of benefits, including fraud; (2) Applicability of the disqualification in section 4(a-2)(iii) of the Railroad Unemployment Insurance Act if the claimant's unemployment results from a strike against a non-railroad employer by which he is employed; (3) Determination of the amount of the Board's claim for reimbursement from pay for time lost payments under section 2(f) of the Railroad Unemployment Insurance Act or damages for personal injury unde… | |||||
| 20:20:1.0.2.9.43.0.155.5 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.8 Notice of initial determination. | SSA | [53 FR 2486, Jan. 28, 1988, as amended at 56 FR 65679, Dec. 18, 1991] | (a) Benefits payable. If benefits are payable for a claim, no special notice of the award will be issued to the claimant. A notice of the award will be sent to the base-year employer(s). The amount of benefits due will be certified to the United States Treasury Department for payment. (b) Benefits not payable. If an initial determination results in denial of a claim, either in whole or in part, the adjudicating office shall issue a notice of the denial within 15 days of the date that it makes its determination. The notice shall explain the basis for the denial of benefits and shall set forth what steps the claimant can take to contest the denial. (c) Communication of notice of denial. When the adjudicating office mails the denial notice to the claimant's address of record, it shall be considered that notice of the denial has been communicated to the claimant on the date of mailing such notice. If the adjudicating office has been notified that a claimant has an attorney or other representative helping him or her with the claim, a copy of the denial notice shall be sent to the attorney or such other representative. | |||||
| 20:20:1.0.2.9.43.0.155.6 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.9 Notice of erroneous benefit payment. | SSA | [53 FR 2486, Jan. 28, 1988] | (a) Content of notice. When an adjudicating office determines that benefits were paid erroneously, that office shall issue to the claimant a notice of the amount of the erroneous payment and the basis for the determination. The notice shall include a statement telling the claimant of his or her right to request reconsideration of the determination, of the provisions for waiver and of his or her right to request waiver. (b) Communication of notice of erroneous payment. When the adjudicating office mails the erroneous payment notice to the claimant's address of record, it shall be considered that notice of the erroneous payment has been communicated to the claimant on the date of mailing such notice. If the adjudicating office has been notified that a claimant has an attorney or other representative helping him or her with the claim, a copy of the erroneous payment notice shall be sent to the attorney or such other representative. | |||||
| 20:20:1.0.2.9.43.0.155.7 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.10 Reconsideration of initial determination. | SSA | [56 FR 65679, Dec. 18, 1991, as amended at 67 FR 77156, Dec. 17, 2002; 71 FR 53004, Sept. 8, 2006; 80 FR 13764, Mar. 17, 2015] | (a) Request. A claimant shall have the right to request reconsideration of an initial determination under § 320.5 of this part which denies in whole or in part his or her claim for benefits. A claimant shall have the right to request reconsideration of a notice of overpayment under § 320.9 of this part. The base-year employer(s) shall have the right to request reconsideration of an initial determination under § 320.5 of this part which awards in whole or in part a claimant's claim for benefits. A reconsideration request shall be made in writing and addressed to the adjudicating office that issued the initial determination and must be received by the adjudicating office no later than 60 days from the date of the notice of the initial decision. A railroad employer may fulfill the written request requirement by using an electronic system that has been approved by the agency in the manner prescribed by the agency. (b) Review of evidence. Upon request, the party requesting reconsideration shall have an opportunity to review all evidence and documents that pertain to the initial determination. The Board shall made all reasonable efforts to protect the identity of the source of adverse evidence. (c) Notice of decision. The adjudicating office shall, as soon as possible, render a decision on the request for reconsideration. If a decision rendered by a district office, as the adjudicating office, sustains the initial determination, either in whole or in part, the decision shall be referred to the appropriate Field Service-Headquarters staff for review prior to issuance. The party who requested reconsideration shall be notified, in writing, of the decision on reconsideration no later than 15 days from the date of the decision or, where the Field Service-Headquarters staff has conducted a review of the decision, within 7 days following the completion of the review. If the decision results in denial of benefits, the claimant shall be notified of the right to appeal as provided in § 320.12 of this part. If the decisio… | |||||
| 20:20:1.0.2.9.43.0.155.8 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.11 Request for waiver of recovery. | SSA | [56 FR 65680, Dec. 18, 1991, as amended at 67 FR 77156, Dec. 17, 2002] | (a) Time limitation. The claimant shall have 60 days from the date of the notification of the erroneous payment determination in which to file a request for waiver, except that where an erroneous payment is not subject to waiver in accordance with § 340.10(e) of this chapter, waiver may not be requested and recovery will not be stayed. Such requests shall be made in writing and be filed by mail or in person at any Board office. The claimant shall, along with the request, submit any evidence and argument which he or she would like to present in support of his or her case. A request solely for reconsideration of an overpayment shall not be considered a request for waiver under this section but shall be treated as a request for reconsideration under § 320.10 of this part. (b) Recovery action. Where a claimant has made a timely request for waiver of recovery, no action will be taken to recover the erroneous payment by setoff against current benefits prior to a decision on such request; provided however, That the Board may, prior to a decision, withhold the amount of the erroneous payment from benefit payments under any of the following circumstances: (1) The claimant admits he or she was at fault in causing the overpayment; (2) The claimant is found to have committed fraud; (3) The claimant authorizes recovery by setoff or agrees to repayment; or (4) The amount of erroneous payment is not subject to waiver or provided for in § 340.10(e) of this chapter. (c) Review of evidence. Upon request, the claimant shall have an opportunity to review all evidence and documents that pertain to the erroneous payment determination. (d) Decision. The Debt Recovery Manager shall make a decision on the claimant's request for waiver of recovery and shall notify the claimant accordingly. The decision of the Manager shall include the basis of the decision, setting forth his or her reasons for the decision including the impact, if any, of any evidence submitted by the base-year or last employer. If the Manager decides tha… | |||||
| 20:20:1.0.2.9.43.0.155.9 | 20 | Employees' Benefits | II | C | 320 | PART 320—INITIAL DETERMINATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT AND REVIEWS OF AND APPEALS FROM SUCH DETERMINATIONS | § 320.12 Appeal to the Bureau of Hearings and Appeals. | SSA | [67 FR 77157, Dec. 17, 2002] | (a) Any party aggrieved by a decision under § 320.10 of this part or a claimant aggrieved by a decision under § 320.11 of this part may appeal such decision to the Bureau of Hearings and Appeals. Such an appeal shall be made by filing the form prescribed by the Board for such purpose. The appeal must be filed with the Bureau of Hearings and Appeals within 60 days from the date upon which notice of the decision on reconsideration or waiver of recovery was mailed to either a claimant or the base year employer(s). Any written request stating an intent to appeal which is received within the 60-day period will protect the claimant's or base-year employer's right to appeal, Provided that the claimant or base-year employer files the appeal form within the later of the 60-day period from the date of the reconsideration decision, or the 30-day period following the date of the Board's letter sending the appeal form to the claimant or base-year employer. (b) If no appeal is filed within the time limits specified in paragraph (a) of this section, the decision of the adjudicating office under §§ 320.10 or 320.11 of this part shall be considered final and no further review of such decision shall be available unless the hearings officer finds that there was good cause for the failure to file a timely appeal as described in § 320.10 of this part. (c) Where a timely appeal seeking waiver of recovery of an erroneous payment has been filed with the Bureau of Hearings and Appeals, the Board shall not commence recovery of the erroneous payment by suspension or reduction of a monthly benefit payable by the Board until a decision with respect to such appeal seeking waiver has been made and notice thereof has been mailed to the claimant. | |||||
| 21:21:5.0.1.1.8.1.1.1 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | A | Subpart A—General Provisions | § 320.1 Definitions. | FDA | [81 FR 69658, Oct. 6, 2016] | The definitions contained in § 314.3 of this chapter apply to those terms when used in this part. | |||
| 21:21:5.0.1.1.8.2.1.1 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.21 Requirements for submission of bioavailability and bioequivalence data. | FDA | [57 FR 17998, Apr. 28, 1992, as amended at 67 FR 77672, Dec. 19, 2002; 74 FR 2862, Jan. 16, 2009] | (a) Any person submitting a full new drug application to the Food and Drug Administration (FDA) shall include in the application either: (1) Evidence measuring the in vivo bioavailability of the drug product that is the subject of the application; or (2) Information to permit FDA to waive the submission of evidence measuring in vivo bioavailability. (b) Any person submitting an abbreviated new drug application to FDA shall include in the application either: (1) Evidence demonstrating that the drug product that is the subject of the abbreviated new drug application is bioequivalent to the reference listed drug (defined in § 314.3(b) of this chapter). A complete study report must be submitted for the bioequivalence study upon which the applicant relies for approval. For all other bioequivalence studies conducted on the same drug product formulation, the applicant must submit either a complete or summary report. If a summary report of a bioequivalence study is submitted and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may require that the applicant submit a complete report of the bioequivalence study to FDA; or (2) Information to show that the drug product is bioequivalent to the reference listed drug which would permit FDA to waive the submission of evidence demonstrating in vivo bioequivalence as provided in paragraph (f) of this section. (c) Any person submitting a supplemental application to FDA shall include in the supplemental application the evidence or information set forth in paragraphs (a) and (b) of this section if the supplemental application proposes any of the following changes: (1) A change in the manufacturing site or a change in the manufacturing process, including a change in product formulation or dosage strength, beyond the variations provided for in the approved application. (2) A change in the labeling to provide for a new indication for use of the drug product, if clinical studies are required to support the new indication for use. (3) A cha… | |||
| 21:21:5.0.1.1.8.2.1.10 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration. | FDA | [57 FR 18000, Apr. 28, 1992, as amended at 67 FR 77674, Dec. 19, 2002; 74 FR 13114, Mar. 26, 2009] | (a) The Commissioner of Food and Drugs strongly recommends that, to avoid the conduct of an improper study and unnecessary human research, any person planning to conduct a bioavailability or bioequivalence study submit the proposed protocol for the study to FDA for review prior to the initiation of the study. (b) FDA may review a proposed protocol for a bioavailability or bioequivalence study and will offer advice with respect to whether the following conditions are met: (1) The design of the proposed bioavailability or bioequivalence study is appropriate. (2) The reference material to be used in the bioavailability or bioequivalence study is appropriate. (3) The proposed chemical and statistical analytical methods are adequate. (c)(1) General inquiries relating to in vivo bioavailability requirements and methodology shall be submitted to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Clinical Pharmacology, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. (2) General inquiries relating to bioequivalence requirements and methodology shall be submitted to the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Bioequivalence (HFD-650), 7500 Standish Pl., Rockville, MD 20855-2773. | |||
| 21:21:5.0.1.1.8.2.1.11 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.31 Applicability of requirements regarding an “Investigational New Drug Application.” | FDA | [57 FR 18000, Apr. 28, 1992, as amended at 58 FR 25927, Apr. 28, 1993; 67 FR 77674, Dec. 19, 2002; 75 FR 59963, Sept. 29, 2010] | (a) Any person planning to conduct an in vivo bioavailability or bioequivalence study in humans shall submit an “Investigational New Drug Application” (IND) if: (1) The test product contains a new chemical entity as defined in § 314.108(a) of this chapter; or (2) The study involves a radioactively labeled drug product; or (3) The study involves a cytotoxic drug product. (b) Any person planning to conduct a bioavailability or bioequivalence study in humans using a drug product that contains an already approved, non-new chemical entity shall submit an IND if the study is one of the following: (1) A single-dose study in normal subjects or patients where either the maximum single or total daily dose exceeds that specified in the labeling of the drug product that is the subject of an approved new drug application or abbreviated new drug application. (2) A multiple-dose study in normal subjects or patients where either the single or total daily dose exceeds that specified in the labeling of the drug product that is the subject of an approved new drug application or abbreviated new drug application. (3) A multiple-dose study on an extended release product on which no single-dose study has been completed. (c) The provisions of parts 50, 56, and 312 of this chapter are applicable to any bioavailability or bioequivalence study in humans conducted under an IND. (d) A bioavailability or bioequivalence study in humans other than one described in paragraphs (a) through (c) of this section is exempt from the requirements of part 312 of this chapter if the following conditions are satisfied: (1) If the study is one described under § 320.38(b) or § 320.63, the person conducting the study, including any contract research organization, must retain reserve samples of any test article and reference standard used in the study and release the reserve samples to FDA upon request, in accordance with, and for the period specified in, § 320.38; (2) An in vivo bioavailability or bioequivalence study in humans must be conducted in… | |||
| 21:21:5.0.1.1.8.2.1.12 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.32 Procedures for establishing or amending a bioequivalence requirement. | FDA | [57 FR 18000, Apr. 28, 1992] | (a) The Food and Drug Administration, on its own initiative or in response to a petition by an interested person, may propose and promulgate a regulation to establish a bioequivalence requirement for a product not subject to section 505(j) of the act if it finds there is well-documented evidence that specific pharmaceutical equivalents or pharmaceutical alternatives intended to be used interchangeably for the same therapeutic effect: (1) Are not bioequivalent drug products; or (2) May not be bioequivalent drug products based on the criteria set forth in § 320.33; or (3) May not be bioequivalent drug products because they are members of a class of drug products that have close structural similarity and similar physicochemical or pharmacokinetic properties to other drug products in the same class that FDA finds are not bioequivalent drug products. (b) FDA shall include in a proposed rule to establish a bioequivalence requirement the evidence and criteria set forth in § 320.33 that are to be considered in determining whether to issue the proposal. If the rulemaking is proposed in response to a petition, FDA shall include in the proposal a summary and analysis of the relevant information that was submitted in the petition as well as other available information to support the establishment of a bioequivalence requirement. (c) FDA, on its own initiative or in response to a petition by an interested person, may propose and promulgate an amendment to a bioequivalence requirement established under this subpart. | |||
| 21:21:5.0.1.1.8.2.1.13 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.33 Criteria and evidence to assess actual or potential bioequivalence problems. | FDA | [42 FR 1635, Jan. 7, 1977. Redesignated and amended at 57 FR 18001, Apr. 28, 1992; 81 FR 17066, Mar. 28, 2016] | The Commissioner of Food and Drugs shall consider the following factors, when supported by well-documented evidence, to identify specific pharmaceutical equivalents and pharmaceutical alternatives that are not or may not be bioequivalent drug products. (a) Evidence from well-controlled clinical trials or controlled observations in patients that such drug products do not give comparable therapeutic effects. (b) Evidence from well-controlled bioequivalence studies that such products are not bioequivalent drug products. (c) Evidence that the drug products exhibit a narrow therapeutic ratio, e.g., there is less than a 2-fold difference in median lethal dose (LD 50 ) and median effective dose (ED 50 ) values, or have less than a 2-fold difference in the minimum toxic concentrations and minimum effective concentrations in the blood, and safe and effective use of the drug products requires careful dosage titration and patient monitoring. (d) Competent medical determination that a lack of bioequivalence would have a serious adverse effect in the treatment or prevention of a serious disease or condition. (e) Physicochemical evidence that: (1) The active drug ingredient has a low solubility in water, e.g., less than 5 milligrams per 1 milliliter, or, if dissolution in the stomach is critical to absorption, the volume of gastric fluids required to dissolve the recommended dose far exceeds the volume of fluids present in the stomach (taken to be 100 milliliters for adults and prorated for infants and children). (2) The dissolution rate of one or more such products is slow, e.g., less than 50 percent in 30 minutes when tested using either a general method specified in an official compendium or a paddle method at 50 revolutions per minute in 900 milliliters of distilled or deionized water at 37 °C, or differs significantly from that of an appropriate reference material such as an identical drug product that is the subject of an approved full new drug application. (3) The particle size and/or surface area of the active … | |||
| 21:21:5.0.1.1.8.2.1.14 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.34 Requirements for batch testing and certification by the Food and Drug Administration. | FDA | [42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992] | (a) If the Commissioner determines that individual batch testing by the Food and Drug Administration is necessary to assure that all batches of the same drug product meet an appropriate in vitro test, he shall include in the bioequivalence requirement a requirement for manufacturers to submit samples of each batch to the Food and Drug Administration and to withhold distribution of the batch until notified by the Food and Drug Administration that the batch may be introduced into interstate commerce. (b) The Commissioner will ordinarily terminate a requirement for a manufacturer to submit samples for batch testing on a finding that the manufacturer has produced four consecutive batches that were tested by the Food and Drug Administration and found to meet the bioequivalence requirement, unless the public health requires that batch testing be extended to additional batches. | |||
| 21:21:5.0.1.1.8.2.1.15 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.35 Requirements for in vitro testing of each batch. | FDA | [42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992] | If a bioequivalence requirement specifies a currently available in vitro test or an in vitro bioequivalence standard comparing the drug product to a reference standard, the manufacturer shall conduct the test on a sample of each batch of the drug product to assure batch-to-batch uniformity. | |||
| 21:21:5.0.1.1.8.2.1.16 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.36 Requirements for maintenance of records of bioequivalence testing. | FDA | [42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992, as amended at 63 FR 5252, Feb. 2, 1998] | (a) All records of in vivo or in vitro tests conducted on any marketed batch of a drug product to assure that the product meets a bioequivalence requirement shall be maintained by the manufacturer for at least 2 years after the expiration date of the batch and submitted to the Food and Drug Administration on request. (b) Any person who contracts with another party to conduct a bioequivalence study from which the data are intended to be submitted to FDA as part of an application submitted under part 314 of this chapter shall obtain from the person conducting the study sufficient accurate financial information to allow the submission of complete and accurate financial certifications or disclosure statements required under part 54 of this chapter and shall maintain that information and all records relating to the compensation given for that study and all other financial interest information required under part 54 of this chapter for 2 years after the date of approval of the application. The person maintaining these records shall, upon request for any properly authorized officer or employee of the Food and Drug Administration, at reasonable time, permit such officer or employee to have access to and copy and verify these records. | |||
| 21:21:5.0.1.1.8.2.1.17 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.38 Retention of bioavailability samples. | FDA | [58 FR 25927, Apr. 28, 1993, as amended at 64 FR 402, Jan. 5, 1999] | (a) The applicant of an application or supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioavailability testing was performed under contract, the contract research organization shall retain an appropriately identified reserve sample of the drug product for which the applicant is seeking approval (test article) and of the reference standard used to perform an in vivo bioavailability study in accordance with and for the studies described in paragraph (b) of this section that is representative of each sample of the test article and reference standard provided by the applicant for the testing. (b) Reserve samples shall be retained for the following test articles and reference standards and for the studies described: (1) If the formulation of the test article is the same as the formulation(s) used in the clinical studies demonstrating substantial evidence of safety and effectiveness for the test article's claimed indications, a reserve sample of the test article used to conduct an in vivo bioavailability study comparing the test article to a reference oral solution, suspension, or injection. (2) If the formulation of the test article differs from the formulation(s) used in the clinical studies demonstrating substantial evidence of safety and effectiveness for the test article's claimed indications, a reserve sample of the test article and of the reference standard used to conduct an in vivo bioequivalence study comparing the test article to the formulation(s) (reference standard) used in the clinical studies. (3) For a new formulation, new dosage form, or a new salt or ester of an active drug ingredient or therapeutic moiety that has been approved for marketing, a reserve sample of the test article and of the reference standard used to conduct an in vivo bioequivalence study comparing the test article to a marketed product (reference standard) that contains the same active drug ingredient or therapeutic moiety. (c) Each reserve sample shall consist of a suff… | |||
| 21:21:5.0.1.1.8.2.1.18 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.63 Retention of bioequivalence samples. | FDA | [58 FR 25928, Apr. 28, 1993, as amended at 64 FR 402, Jan. 5, 1999] | The applicant of an abbreviated application or a supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioequivalence testing was performed under contract, the contract research organization shall retain reserve samples of any test article and reference standard used in conducting an in vivo or in vitro bioequivalence study required for approval of the abbreviated application or supplemental application. The applicant or contract research organization shall retain the reserve samples in accordance with, and for the period specified in, § 320.38 and shall release the reserve samples to FDA upon request in accordance with § 320.38. | |||
| 21:21:5.0.1.1.8.2.1.2 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence. | FDA | [57 FR 17998, Apr. 28, 1992, as amended at 67 FR 77673, Dec. 19, 2002] | (a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c), may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioequivalence of the drug product that is the subject of the application. An applicant shall submit a request for waiver with the application. Except as provided in paragraph (f) of this section, FDA shall waive the requirement for the submission of evidence of in vivo bioavailability or bioequivalence if the drug product meets any of the provisions of paragraphs (b), (c), (d), or (e) of this section. (b) For certain drug products, the in vivo bioavailability or bioequivalence of the drug product may be self-evident. FDA shall waive the requirement for the submission of evidence obtained in vivo measuring the bioavailability or demonstrating the bioequivalence of these drug products. A drug product's in vivo bioavailability or bioequivalence may be considered self-evident based on other data in the application if the product meets one of the following criteria: (1) The drug product: (i) Is a parenteral solution intended solely for administration by injection, or an ophthalmic or otic solution; and (ii) Contains the same active and inactive ingredients in the same concentration as a drug product that is the subject of an approved full new drug application or abbreviated new drug application. (2) The drug product: (i) Is administered by inhalation as a gas, e.g., a medicinal or an inhalation anesthetic; and (ii) Contains an active ingredient in the same dosage form as a drug product that is the subject of an approved full new drug application or abbreviated new drug application. (3) The drug product: (i) Is a solution for application to the skin, an oral solution, elixir, syrup, tincture, a solution for aerosolization or nebulization, a nasal solution, or similar other solubilized form; and (ii) Contains an active d… | |||
| 21:21:5.0.1.1.8.2.1.3 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence. | FDA | [57 FR 17999, Apr. 28, 1992, as amended at 67 FR 77673, Dec. 19, 2002, 81 FR 69658, Oct. 6, 2016] | (a)(1) The in vivo bioavailability of a drug product is measured if the product's rate and extent of absorption, as determined by comparison of measured parameters, e.g., concentration of the active drug ingredient in the blood, urinary excretion rates, or pharmacological effects, do not indicate a significant difference from the reference material's rate and extent of absorption. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action. (2) Statistical techniques used must be of sufficient sensitivity to detect differences in rate and extent of absorption that are not attributable to subject variability. (3) A drug product that differs from the reference material in its rate of absorption, but not in its extent of absorption, may be considered to be bioavailable if the difference in the rate of absorption is intentional, is appropriately reflected in the labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug product. (b)(1) Two drug products will be considered bioequivalent drug products if they are pharmaceutical equivalents or pharmaceutical alternatives whose rate and extent of absorption do not show a significant difference when administered at the same molar dose of the active moiety under similar experimental conditions, either single dose or multiple dose. Some pharmaceutical equivalents or pharmaceutical alternatives may be equivalent in the extent of their absorption but not in their rate of absorption and yet may be considered bioequivalent because such differences in the rate of absorption are intentional and are reflected in the labeling, are not essential to the attainment of effective body drug concentrations on chronic use, and are considered medically insignificant for the particular… | |||
| 21:21:5.0.1.1.8.2.1.4 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.24 Types of evidence to measure bioavailability or establish bioequivalence. | FDA | [57 FR 17999, Apr. 28, 1992; 57 FR 29354, July 1, 1992, as amended at 67 FR 77673, Dec. 19, 2002] | (a) Bioavailability may be measured or bioequivalence may be demonstrated by several in vivo and in vitro methods. FDA may require in vivo or in vitro testing, or both, to measure the bioavailability of a drug product or establish the bioequivalence of specific drug products. Information on bioequivalence requirements for specific products is included in the current edition of FDA's publication “Approved Drug Products with Therapeutic Equivalence Evaluations” and any current supplement to the publication. The selection of the method used to meet an in vivo or in vitro testing requirement depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Applicants shall conduct bioavailability and bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in paragraph (b) of this section. The method used must be capable of measuring bioavailability or establishing bioequivalence, as appropriate, for the product being tested. (b) The following in vivo and in vitro approaches, in descending order of accuracy, sensitivity, and reproducibility, are acceptable for determining the bioavailability or bioequivalence of a drug product. (1)(i) An in vivo test in humans in which the concentration of the active ingredient or active moiety, and, when appropriate, its active metabolite(s), in whole blood, plasma, serum, or other appropriate biological fluid is measured as a function of time. This approach is particularly applicable to dosage forms intended to deliver the active moiety to the bloodstream for systemic distribution within the body; or (ii) An in vitro test that has been correlated with and is predictive of human in vivo bioavailability data; or (2) An in vivo test in humans in which the urinary excretion of the active moiety, and, when appropriate, its active metabolite(s), are measured as a function of time. The intervals at which measurements are taken should ordinarily be as short as possible so that the mea… | |||
| 21:21:5.0.1.1.8.2.1.5 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.25 Guidelines for the conduct of an in vivo bioavailability study. | FDA | [42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002] | (a) Guiding principles. (1) The basic principle in an in vivo bioavailability study is that no unnecessary human research should be done. (2) An in vivo bioavailability study is generally done in a normal adult population under standardized conditions. In some situations, an in vivo bioavailability study in humans may preferably and more properly be done in suitable patients. Critically ill patients shall not be included in an in vivo bioavailability study unless the attending physician determines that there is a potential benefit to the patient. (b) Basic design. The basic design of an in vivo bioavailability study is determined by the following: (1) The scientific questions to be answered. (2) The nature of the reference material and the dosage form to be tested. (3) The availability of analytical methods. (4) Benefit-risk considerations in regard to testing in humans. (c) Comparison to a reference material. In vivo bioavailability testing of a drug product shall be in comparison to an appropriate reference material unless some other approach is more appropriate for valid scientific reasons. (d) Previously unmarketed active drug ingredients or therapeutic moieties. (1) An in vivo bioavailability study involving a drug product containing an active drug ingredient or therapeutic moiety that has not been approved for marketing can be used to measure the following pharmacokinetic data: (i) The bioavailability of the formulation proposed for marketing; and (ii) The essential pharmacokinetic characteristics of the active drug ingredient or therapeutic moiety, such as the rate of absorption, the extent of absorption, the half-life of the therapeutic moiety in vivo, and the rate of excretion and/or metabolism. Dose proportionality of the active drug ingredient or the therapeutic moiety needs to be established after single-dose administration and in certain instances after multiple-dose administration. This characterization is a necessary part of the investigation of the drug to support drug labeling. … | |||
| 21:21:5.0.1.1.8.2.1.6 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study. | FDA | [42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002] | (a) Basic principles. (1) An in vivo bioavailability or bioequivalence study should be a single-dose comparison of the drug product to be tested and the appropriate reference material conducted in normal adults. (2) The test product and the reference material should be administered to subjects in the fasting state, unless some other approach is more appropriate for valid scientific reasons. (b) Study design. (1) A single-dose study should be crossover in design, unless a parallel design or other design is more appropriate for valid scientific reasons, and should provide for a drug elimination period. (2) Unless some other approach is appropriate for valid scientific reasons, the drug elimination period should be either: (i) At least three times the half-life of the active drug ingredient or therapeutic moiety, or its metabolite(s), measured in the blood or urine; or (ii) At least three times the half-life of decay of the acute pharmacological effect. (c) Collection of blood samples. (1) When comparison of the test product and the reference material is to be based on blood concentration time curves, unless some other approach is more appropriate for valid scientific reasons, blood samples should be taken with sufficient frequency to permit an estimate of both: (i) The peak concentration in the blood of the active drug ingredient or therapeutic moiety, or its metabolite(s), measured; and (ii) The total area under the curve for a time period at least three times the half-life of the active drug ingredient or therapeutic moiety, or its metabolite(s), measured. (2) In a study comparing oral dosage forms, the sampling times should be identical. (3) In a study comparing an intravenous dosage form and an oral dosage form, the sampling times should be those needed to describe both: (i) The distribution and elimination phase of the intravenous dosage form; and (ii) The absorption and elimination phase of the oral dosage form. (4) In a study comparing drug delivery systems other than oral or intravenous d… | |||
| 21:21:5.0.1.1.8.2.1.7 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study. | FDA | [42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002] | (a) Basic principles. (1) In selected circumstances it may be necessary for the test product and the reference material to be compared after repeated administration to determine steady-state levels of the active drug ingredient or therapeutic moiety in the body. (2) The test product and the reference material should be administered to subjects in the fasting or nonfasting state, depending upon the conditions reflected in the proposed labeling of the test product. (3) A multiple-dose study may be required to determine the bioavailability of a drug product in the following circumstances: (i) There is a difference in the rate of absorption but not in the extent of absorption. (ii) There is excessive variability in bioavailability from subject to subject. (iii) The concentration of the active drug ingredient or therapeutic moiety, or its metabolite(s), in the blood resulting from a single dose is too low for accurate determination by the analytical method. (iv) The drug product is an extended release dosage form. (b) Study design. (1) A multiple-dose study should be crossover in design, unless a parallel design or other design is more appropriate for valid scientific reasons, and should provide for a drug elimination period if steady-state conditions are not achieved. (2) A multiple-dose study is not required to be of crossover design if the study is to establish dose proportionality under a multiple-dose regimen or to establish the pharmacokinetic profile of a new drug product, a new drug delivery system, or an extended release dosage form. (3) If a drug elimination period is required, unless some other approach is more appropriate for valid scientific reasons, the drug elimination period should be either: (i) At least five times the half-life of the active drug ingredient or therapeutic moiety, or its active metabolite(s), measured in the blood or urine; or (ii) At least five times the half-life of decay of the acute pharmacological effect. (c) Achievement of steady-state conditions. Whenever a mu… | |||
| 21:21:5.0.1.1.8.2.1.8 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence. | FDA | [42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002] | Correlation of in vivo bioavailability data with an acute pharmacological effect or clinical evidence of safety and effectiveness may be required if needed to establish the clinical significance of a special claim, e.g., in the case of an extended release preparation. | |||
| 21:21:5.0.1.1.8.2.1.9 | 21 | Food and Drugs | I | D | 320 | PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS | B | Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products | § 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study. | FDA | [42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002] | (a) The analytical method used in an in vivo bioavailability or bioequivalence study to measure the concentration of the active drug ingredient or therapeutic moiety, or its active metabolite(s), in body fluids or excretory products, or the method used to measure an acute pharmacological effect shall be demonstrated to be accurate and of sufficient sensitivity to measure, with appropriate precision, the actual concentration of the active drug ingredient or therapeutic moiety, or its active metabolite(s), achieved in the body. (b) When the analytical method is not sensitive enough to measure accurately the concentration of the active drug ingredient or therapeutic moiety, or its active metabolite(s), in body fluids or excretory products produced by a single dose of the test product, two or more single doses may be given together to produce higher concentration if the requirements of § 320.31 are met. | |||
| 24:24:2.1.2.5.3.1.221.1 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.1 General. | HUD | The Association is authorized by section 306(g) of the National Housing Act (12 U.S.C. 1721(g)) upon such terms and conditions as it may deem appropriate, to guarantee the timely payment of principal of and interest on securities that are based on and backed by a trust or pool composed of mortgages which are insured or guaranteed by FHA, FmHA or VA. The Association's guaranty of mortgage-backed securities is backed by the full faith and credit of the United States. This subpart is limited to “modified pass-through” securities, and does not purport to set forth all the procedures and requirements that apply to the issuance and guaranty of such securities. All such transactions are governed by the specific terms and provisions of the Association's Mortgage-Backed Securities Guides (MBS Guides) and contracts entered into by the parties. | |||||
| 24:24:2.1.2.5.3.1.221.10 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.13 Guaranty. | HUD | [64 FR 34107, June 24, 1999] | The Association guarantees the timely payment, whether or not collected, of the interest on the outstanding balance and the specified principal installments on securities that are registered on Ginnie Mae's central registry. The Association's guaranty is backed by the full faith and credit of the United States. | ||||
| 24:24:2.1.2.5.3.1.221.11 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.15 Default. | HUD | (a) Issuer default. Any failure or inability of the issuer to make payments as due as well as such other events as may be identified by the Association and included in the applicable guaranty agreement, contractual agreement or MBS Guide, shall constitute a default of the issuer. (b) Action upon default. Upon any default by the issuer, the Association may: (1) Institute a claim against the issuer's insurance, bond or other coverage, as specified in § 320.11; (2) Pursuant to section 306(g) of the National Housing Act (12 U.S.C. 1721(g)), extinguish all the right, title, or other interest of the issuer in the pooled mortgages; and (3) Exercise such other rights and remedies as it may have. | |||||
| 24:24:2.1.2.5.3.1.221.12 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.17 Fees. | HUD | The Association may impose application fees, guaranty fees, securities transfer fees and other fees. | |||||
| 24:24:2.1.2.5.3.1.221.2 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.3 Eligible issuers of securities. | HUD | (a) Eligibility requirements. A mortgage lender, including an instrumentality of a State or local government, to be eligible to issue or service mortgage-backed securities guaranteed by the Association must satisfy all of the following standards: (1) Be in good standing as a mortgagee approved by the FHA; (2) Be in good standing as a mortgage seller or servicer approved by the Federal National Mortgage Association (FNMA), the Federal Home Loan Mortgage Corporation (FHLMC), or the Association. Loss of either FNMA approval or FHLMC approval may cause the issuer to become ineligible to issue and service the Association's mortgage-backed securities and constitute a default under the applicable guaranty or contractual agreement whether or not the issuer qualified for new issuer approval on the basis of FNMA or FHLMC approval; (3) Have management with adequate experience, and access to adequate facilities to issue or service mortgage-backed securities, as determined by the Association; (4) Maintain the applicable minimum net worth discussed in paragraph (c) of this section; and (5) Meet the requirements, conditions, and limitations prescribed by the Association in this part or the applicable MBS Guides. (b) Time of eligibility. The Association shall not commit to guarantee, or guarantee any issue of mortgage-backed securities unless the mortgage lender requesting such commitment or guaranty qualifies as an eligible issuer both at the time of commitment approval and at the time of the issuance of the guaranty. (c) Net worth requirements. Issuers shall maintain at all times a net worth acceptable to the Association of not less than the applicable minimum amount. The applicable minimum amount shall be published in the MBS Guides. (d) Disqualification. A mortgage lender shall not qualify as an eligible issuer at any time in which: (1) The lending policies of the issuer permit any discrimination based on race, religion, color, national origin, age, or sex of a borrower; or (2) The issuer is not in complian… | |||||
| 24:24:2.1.2.5.3.1.221.3 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.5 Securities. | HUD | [60 FR 42015, Aug. 14, 1995, as amended at 63 FR 51251, Sept. 24, 1998; 64 FR 34106, June 24, 1999; 66 FR 44265, Aug. 22, 2001; 70 FR 33652, June 8, 2005; 72 FR 49125, Aug. 27, 2007] | (a) Instruments. Securities issued pursuant to the provisions of this subpart must be modified pass-through securities, that provide for payment, whether or not collected, of both specified principal installments and interest on the unpaid principal balance, with all prepayments and other unscheduled recoveries of principal being passed through to the holder. In the case of delinquent mortgages in a pool backing modified pass-through securities, the issuer is required to make advances if necessary to maintain the specified schedule of interest and principal payments to the holders, or at its option, at any time 90 days or more after default of any such mortgage, the issuer may repurchase such mortgage for an amount equal to the unpaid principal balance of the mortgage. The securities, if issued in certificated form, must specify the dates by which payments are to be made to the holders thereof, and must indicate the accounting period for collections on the pool's mortgages relating to each such payment, and the securities, if issued in certificated form, must also specify a date on which the entire principal will have been paid or will be payable. (b) Issue amount. Each issue of guaranteed securities must be in a minimum face amount as specified in the applicable MBS Guide. The total face amount of any issue of securities cannot exceed the aggregate unpaid principal balances of the mortgages in the pool. The Association may provide for issuers to submit packages of mortgages that may be consolidated, with other packages of similar types of mortgages, into multiple issuer pools. (c) [Reserved] (d) Transferability. Securities are transferable, but the share of the proceeds collected on account of the pool of mortgages is payable only to the registered holder of a security according to the policies established by the Association. (e) Issue Date. Securities backed by single-family mortgages with issue dates of October 1, 1998, or before, serial notes with issue dates of July 1, 2002, or before, and securi… | ||||
| 24:24:2.1.2.5.3.1.221.4 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.7 Mortgages. | HUD | Each issue of guaranteed securities must be backed by a separate pool of mortgages which meet the requirements of the applicable MBS Guide. | |||||
| 24:24:2.1.2.5.3.1.221.5 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.8 Excess Yield Securities. | HUD | [71 FR 32389, June 5, 2006] | (a) Definition. Excess Yield Securities are securities backed by the excess servicing income relating to mortgages underlying previously issued Ginnie Mae mortgage-backed securities. (b) GNMA guaranty. The Association guarantees the timely payment of interest as provided by the terms of the security. | ||||
| 24:24:2.1.2.5.3.1.221.6 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.9 Pool administration. | HUD | The Association will only guarantee securities if the issuer executes a guaranty agreement or contractual agreement in the form prescribed by the Association. Pool administration requirements are set forth in such agreements or the applicable MBS Guide. | |||||
| 24:24:2.1.2.5.3.1.221.7 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.10 Financial reporting. | HUD | [72 FR 49125, Aug. 27, 2007] | Issuers shall submit to the Association audited annual financial statements within 90 days of their fiscal year end. All financial statements shall include a balance sheet and a statement of operations and cash flows. The audit shall be conducted in accordance with the standards for financial audits of the U.S. Government Accountability Office's Government Auditing Standards, issued by the Comptroller General of the United States. | ||||
| 24:24:2.1.2.5.3.1.221.8 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.11 Insurance coverage. | HUD | The issuer shall maintain, for the benefit of the Association, insurance, errors and omissions, fidelity bond and other coverage as required by the Association and set forth in the appropriate MBS Guide. | |||||
| 24:24:2.1.2.5.3.1.221.9 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | A | Subpart A—Pass-Through Type Securities | § 320.12 Integrity. | HUD | (a) Background. Issuers shall disclose the background of all individuals serving on their Board of Directors and all individuals acting as authorized signatories. The disclosures shall include any prior convictions, fines or other adverse actions against these individuals by a Federal, state or local agency, or a government-related entity where the action is related to the responsibilities that are commensurate with those of the financial services industry. The term government-related entity includes, but is not limited to, FHA, VA, FmHA, FNMA, FHLMC, Office of Thrift Supervision, Federal Deposit Insurance Corporation, Office of the Comptroller of the Currency, Board of Governors of the Federal Reserve System, and National Credit Union Administration. (b) Change in status. Issuers shall disclose material changes in their status with other government-related entities and regulatory agencies, or state or local agencies with similar authority, within 5 business days of their occurrence. The disclosures shall include, but not be limited to, voluntary and non-voluntary terminations, defaults, fines, and material non-compliance with agency rules and policies. Disclosures that are specifically prohibited by an agency are exempted from this section. | |||||
| 24:24:2.1.2.5.3.2.221.1 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | B | Subpart B—Bond-Type Securities | § 320.21 General. | HUD | In addition to the “pass-through” securities dealt with in subpart A of this part, the Association is authorized by section 306(g) of the National Housing Act, 12 U.S.C. 1721(g), upon such terms and conditions as it may deem appropriate, to guarantee the timely payment of principal of and interest on “bond-type” securities which are based on and backed by a trust or pool composed of mortgages which are insured or guaranteed by FHA, FmHA or the VA. The Association's guaranty of mortgage-backed securities is backed by the full faith and credit of the United States. This subpart deals with such “bond-type” securities and does not purport to set forth all the procedures and requirements that apply to the issuance and guaranty of such securities. All such transactions are governed by the specific terms and provisions of the contracts entered into by the parties and the Bond-Type Securities Guide (the “Bond Guide”). | |||||
| 24:24:2.1.2.5.3.2.221.2 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | B | Subpart B—Bond-Type Securities | § 320.23 Eligible issuers. | HUD | Any corporation, trust, partnership, or other entity with a net worth acceptable to the Association as set forth in the Bond Guide, which has the capability to assemble acceptable and eligible mortgages in sufficient quantity to support required minimum issuances of securities and which meets such other requirements as are set forth in the Bond Guide, may be approved to issue and service bond-type securities guaranteed by the Association. Further, the Association reserves the right to limit the number of issuers in the interest of conducting an orderly market of securities of this type. | |||||
| 24:24:2.1.2.5.3.2.221.3 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | B | Subpart B—Bond-Type Securities | § 320.25 Securities. | HUD | (a) Instruments. Securities to be issued pursuant to the provisions of this subpart B may be in registered or bearer form. Each security shall have terms acceptable to the Association as provided in the Bond Guide. (b) Issue amount. Each issue of guaranteed securities must be in a minimum face amount as specified in the Bond Guide. The total face amount of any issue of securities cannot exceed the aggregate unpaid principal balances of the mortgages in the pool. (c) Face amount of securities. The face amount of any security cannot be less than $25,000. (d) Transferability. Bearer securities are freely transferrable. Registered securities are transferable only on the books of an agent, as shall be agreed upon by the Association and the issuer. (e) Treasury approval. Issues of $100 million or larger will be subject to approval of the Secretary of the Treasury. | |||||
| 24:24:2.1.2.5.3.2.221.4 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | B | Subpart B—Bond-Type Securities | § 320.27 Mortgages. | HUD | Guaranteed securities issued under these provisions must be based on and backed by mortgages pooled under trust arrangements satisfactory to the Association. Such mortgages must meet the requirements of the Bond Guide. | |||||
| 24:24:2.1.2.5.3.2.221.5 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | B | Subpart B—Bond-Type Securities | § 320.29 Guaranty. | HUD | With respect to bond-type securities, the Association will guarantee the timely payment of principal of and interest on such securities, subject to the terms and conditions of the securities. The Association's guaranty is backed by the full faith and credit of the United States. | |||||
| 24:24:2.1.2.5.3.2.221.6 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | B | Subpart B—Bond-Type Securities | § 320.31 Default. | HUD | Upon default of the issuer, the Association has the right, pursuant to section 306(g) of the National Housing Act (12 U.S.C. 1721(g)), to take title to the mortgages and other assets that are subject to the trust arrangements, and to proceed against other assets of the issuer to the extent necessary to satisfy its own claims and the rights of the holders of securities then outstanding. Such action by the Association shall be taken subject to an accounting to the issuer. | |||||
| 24:24:2.1.2.5.3.2.221.7 | 24 | Housing and Urban Development | III | 320 | PART 320—GUARANTY OF MORTGAGE-BACKED SECURITIES | B | Subpart B—Bond-Type Securities | § 320.33 Fees. | HUD | The Association may impose application and guaranty fees, which may vary with relation to the size or risk of the guaranty transaction undertaken. | |||||
| 33:33:3.0.1.1.14.0.1.1 | 33 | Navigation and Navigable Waters | II | 320 | PART 320—GENERAL REGULATORY POLICIES | § 320.1 Purpose and scope. | USACE | [51 FR 41220, Nov. 13, 1986, as amended at 64 FR 11714, Mar. 9, 1999; 65 FR 16492, Mar. 28, 2000] | (a) Regulatory approach of the Corps of Engineers. (1) The U.S. Army Corps of Engineers has been involved in regulating certain activities in the nation's waters since 1890. Until 1968, the primary thrust of the Corps' regulatory program was the protection of navigation. As a result of several new laws and judicial decisions, the program has evolved to one involving the consideration of the full public interest by balancing the favorable impacts against the detrimental impacts. This is known as the “public interest review.” The program is one which reflects the national concerns for both the protection and utilization of important resources. (2) The Corps is a highly decentralized organization. Most of the authority for administering the regulatory program has been delegated to the thirty-six district engineers and eleven division engineers. A district engineer's decision on an approved jurisdictional determination, a permit denial, or a declined individual permit is subject to an administrative appeal by the affected party in accordance with the procedures and authorities contained in 33 CFR part 331. Such administrative appeal must meet the criteria in 33 CFR 331.5; otherwise, no administrative appeal of that decision is allowed. The terms “approved jurisdictional determination,” “permit denial,” and “declined permit” are defined at 33 CFR 331.2. There shall be no administrative appeal of any issued individual permit that an applicant has accepted, unless the authorized work has not started in waters of the United States, and that issued permit is subsequently modified by the district engineer pursuant to 33 CFR 325.7 (see 33 CFR 331.5(b)(1)). An affected party must exhaust any administrative appeal available pursuant to 33 CFR part 331 and receive a final Corps decision on the appealed action prior to filing a lawsuit in the Federal courts (see 33 CFR 331.12). (3) The Corps seeks to avoid unnecessary regulatory controls. The general permit program described in 33 CFR parts 325 and 330 is the primary method… | ||||||
| 33:33:3.0.1.1.14.0.1.2 | 33 | Navigation and Navigable Waters | II | 320 | PART 320—GENERAL REGULATORY POLICIES | § 320.2 Authorities to issue permits. | USACE | (a) Section 9 of the Rivers and Harbors Act, approved March 3, 1899 (33 U.S.C. 401) (hereinafter referred to as section 9), prohibits the construction of any dam or dike across any navigable water of the United States in the absence of Congressional consent and approval of the plans by the Chief of Engineers and the Secretary of the Army. Where the navigable portions of the waterbody lie wholly within the limits of a single state, the structure may be built under authority of the legislature of that state if the location and plans or any modification thereof are approved by the Chief of Engineers and by the Secretary of the Army. The instrument of authorization is designated a permit (See 33 CFR part 321.) Section 9 also pertains to bridges and causeways but the authority of the Secretary of the Army and Chief of Engineers with respect to bridges and causeways was transferred to the Secretary of Transportation under the Department of Transportation Act of October 15, 1966 (49 U.S.C. 1155g(6)(A)). A DA permit pursuant to section 404 of the Clean Water Act is required for the discharge of dredged or fill material into waters of the United States associated with bridges and causeways. (See 33 CFR part 323.) (b) Section 10 of the Rivers and Harbors Act approved March 3, 1899, (33 U.S.C. 403) (hereinafter referred to as section 10), prohibits the unauthorized obstruction or alteration of any navigable water of the United States. The construction of any structure in or over any navigable water of the United States, the excavating from or depositing of material in such waters, or the accomplishment of any other work affecting the course, location, condition, or capacity of such waters is unlawful unless the work has been recommended by the Chief of Engineers and authorized by the Secretary of the Army. The instrument of authorization is designated a permit. The authority of the Secretary of the Army to prevent obstructions to navigation in navigable waters of the United States was extended to artificial islands, instal… | |||||||
| 33:33:3.0.1.1.14.0.1.3 | 33 | Navigation and Navigable Waters | II | 320 | PART 320—GENERAL REGULATORY POLICIES | § 320.3 Related laws. | USACE | [51 FR 41220, Nov. 13, 1986, as amended at 90 FR 29471, July 3, 2025] | (a) Section 401 of the Clean Water Act (33 U.S.C. 1341) requires any applicant for a federal license or permit to conduct any activity that may result in a discharge of a pollutant into waters of the United States to obtain a certification from the State in which the discharge originates or would originate, or, if appropriate, from the interstate water pollution control agency having jurisdiction over the affected waters at the point where the discharge originates or would originate, that the discharge will comply with the applicable effluent limitations and water quality standards. A certification obtained for the construction of any facility must also pertain to the subsequent operation of the facility. (b) Section 307(c) of the Coastal Zone Management Act of 1972, as amended (16 U.S.C. 1456(c)), requires federal agencies conducting activities, including development projects, directly affecting a state's coastal zone, to comply to the maximum extent practicable with an approved state coastal zone management program. Indian tribes doing work on federal lands will be treated as a federal agency for the purpose of the Coastal Zone Management Act. The Act also requires any non-federal applicant for a federal license or permit to conduct an activity affecting land or water uses in the state's coastal zone to furnish a certification that the proposed activity will comply with the state's coastal zone management program. Generally, no permit will be issued until the state has concurred with the non-federal applicant's certification. This provision becomes effective upon approval by the Secretary of Commerce of the state's coastal zone management program. (See 15 CFR part 930.) (c) Section 302 of the Marine Protection, Research and Sanctuaries Act of 1972, as amended (16 U.S.C. 1432), authorizes the Secretary of Commerce, after consultation with other interested federal agencies and with the approval of the President, to designate as marine sanctuaries those areas of the ocean waters, of the Great Lakes and their con… | ||||||
| 33:33:3.0.1.1.14.0.1.4 | 33 | Navigation and Navigable Waters | II | 320 | PART 320—GENERAL REGULATORY POLICIES | § 320.4 General policies for evaluating permit applications. | USACE | The following policies shall be applicable to the review of all applications for DA permits. Additional policies specifically applicable to certain types of activities are identified in 33 CFR parts 321 through 324. (a) Public interest review. (1) The decision whether to issue a permit will be based on an evaluation of the probable impacts, including cumulative impacts, of the proposed activity and its intended use on the public interest. Evaluation of the probable impact which the proposed activity may have on the public interest requires a careful weighing of all those factors which become relevant in each particular case. The benefits which reasonably may be expected to accrue from the proposal must be balanced against its reasonably foreseeable detriments. The decision whether to authorize a proposal, and if so, the conditions under which it will be allowed to occur, are therefore determined by the outcome of this general balancing process. That decision should reflect the national concern for both protection and utilization of important resources. All factors which may be relevant to the proposal must be considered including the cumulative effects thereof: among those are conservation, economics, aesthetics, general environmental concerns, wetlands, historic properties, fish and wildlife values, flood hazards, floodplain values, land use, navigation, shore erosion and accretion, recreation, water supply and conservation, water quality, energy needs, safety, food and fiber production, mineral needs, considerations of property ownership and, in general, the needs and welfare of the people. For activities involving 404 discharges, a permit will be denied if the discharge that would be authorized by such permit would not comply with the Environmental Protection Agency's 404(b)(1) guidelines. Subject to the preceding sentence and any other applicable guidelines and criteria (see §§ 320.2 and 320.3), a permit will be granted unless the district engineer determines that it would be contrary to the public interes… | |||||||
| 9:9:2.0.2.1.21.0.7.1 | 9 | Animals and Animal Products | III | A | 320 | PART 320—RECORDS, REGISTRATION, AND REPORTS | § 320.1 Records required to be kept. | FSIS | [35 FR 15603, Oct. 3, 1970] | (a) Every person (including every firm or corporation) within any of the classes specified in paragraph (a) (1), (2), or (3) of this section is required by the Act to keep records which will fully and correctly disclose all transactions involved in his or its business subject to the Act: (1) Any person that engages, for commerce, in the business of slaughtering any cattle, sheep, swine, goats, horses, mules, or other equines, or preparing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any such animals, for use as human food or animal food; (2) Any person that engages in the business of buying or selling (as a meat broker, wholesaler, or otherwise), or transporting in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any such animals; (3) Any person that engages in business, in or for commerce, as a renderer, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules, or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter. (b) The required records are: (1) Records, such as bills of sale, invoices, bills of lading, and receiving and shipping papers, giving the following information with respect to each transaction in which any livestock or carcass, part thereof, meat or meat food product is purchased, sold, shipped, received, transported, or otherwise handled by said person in connection with any business subject to the Act: (i) The name or description of the livestock or article; (ii) The net weight of the livestock or article; (iii) The number of outside containers (if any); (iv) The name and address of the buyer of livestock or article sold by such person, and the name and address of the seller of livestock or articles purchased by such person; (v) The name and address of the consignee or receiver (if other than the buyer); (vi) The method of shipm… | |||||
| 9:9:2.0.2.1.21.0.7.2 | 9 | Animals and Animal Products | III | A | 320 | PART 320—RECORDS, REGISTRATION, AND REPORTS | § 320.2 Place of maintenance of records. | FSIS | [80 FR 79250, Dec. 21, 2015] | (a) Except as provided in paragraph (b) of this section, any person engaged in any business described in § 320.1 and required by this part to keep records must maintain such records at the place where such business is conducted, except that if such person conducts such business at multiple locations, he may maintain such records at his headquarters' office. When not in actual use, all such records must be kept in a safe place at the prescribed location in accordance with good commercial practices. (b) Records required to kept under § 320.1(b)(4) must be kept at the location where the raw beef was ground. | |||||
| 9:9:2.0.2.1.21.0.7.3 | 9 | Animals and Animal Products | III | A | 320 | PART 320—RECORDS, REGISTRATION, AND REPORTS | § 320.3 Record retention period. | FSIS | [80 FR 79250, Dec. 21, 2015] | (a) Except as provided in paragraphs (b) and (c) of this section, every record required to be maintained under this part must be retained for a period of 2 years after December 31 of the year in which the transaction to which the record relates has occurred and for such further period as the Administrator may require for purposes of any investigation or litigation under the Act, by written notice to the person required to keep such records under this part. (b) Records of canning as required in subpart G of part 318 of this chapter, must be retained as required in § 318.307(e); except that records required by § 318.302(b) and (c) must be retained as required by those sections. (c) Records required to be maintained under § 320.1(b)(4) must be retained for one year. | |||||
| 9:9:2.0.2.1.21.0.7.4 | 9 | Animals and Animal Products | III | A | 320 | PART 320—RECORDS, REGISTRATION, AND REPORTS | § 320.4 Access to and inspection of records, facilities and inventory; copying and sampling. | FSIS | [69 FR 254, Jan. 5, 2004] | Representatives of the Secretary afforded access to a business specified in § 320.1 of this part (see § 300.6(b)(2) of this chapter) also must be afforded any necessary facilities (other than reproduction equipment) for the examination and copying of records and for the examination and sampling of inventory. | |||||
| 9:9:2.0.2.1.21.0.7.5 | 9 | Animals and Animal Products | III | A | 320 | PART 320—RECORDS, REGISTRATION, AND REPORTS | § 320.5 Registration. | FSIS | [35 FR 15603, Oct. 3, 1970, as amended at 57 FR 53982, Nov. 16, 1992; 69 FR 254, Jan. 5, 2004] | (a) Except as provided in paragraph (c) of this section, every person that engages in business in or for commerce, as a meat broker, renderer, or animal food manufacturer, or engages in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, or any livestock, whether intended for human food or other purposes, or engages in business as a public warehouseman storing any such articles in or for commerce, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased livestock, or parts of the carcasses of any such livestock that died otherwise than by slaughter, shall register with the Administrator, giving such information as is required, including his name, and the address of each place of business at which, and all trade names under which he conducts such business, by filing with the Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, a form containing such information within 90 days after the effective date hereof or after such later date as he begins to engage in such business if not engaged therein upon said effective date. All information submitted shall be current and correct. The registration form shall be obtained from Evaluation and Enforcement Division, Office of Program Evaluation, Enforcement, and Review, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, or by calling the District Office. (b) Whenever any change is made in the name of, or address of any place of business at which, or any trade name under which a registrant conducts his business, he shall report such change in writing to the Administrator within 15 days after making the change. (c) The registration requirements prescribed in this section shall not apply to persons conducting any of the businesses specified in this section only at an official establishment. | |||||
| 9:9:2.0.2.1.21.0.7.6 | 9 | Animals and Animal Products | III | A | 320 | PART 320—RECORDS, REGISTRATION, AND REPORTS | § 320.6 Information and reports required from official establishment operators. | FSIS | [35 FR 15603, Oct. 3, 1970, as amended at 45 FR 76968, Nov. 21, 1980; 61 FR 38866, July 25, 1996] | (a) The operator of each official establishment shall furnish to Program employees accurate information as to all matters needed by them for making their daily reports of the amount of products prepared or handled in the departments of the establishment to which they are assigned and such reports concerning sanitation, mandatory microbiological testing, and other aspects of the operations of the establishment and the conduct of inspection, as may be required by the Administrator in special cases. (b) The operator of each official establishment shall report quarterly the number of pounds of meat and meat food product produced at that establishment. The report shall be made on a form furnished by the Administrator and shall be submitted to an inspector at the establishment. Each report shall cover a calendar quarter and shall be filed within 15 days after the end of each quarter. (c) The operator of each official establishment shall also make such other reports as the Administrator may from time to time require under the Act. | |||||
| 9:9:2.0.2.1.21.0.7.7 | 9 | Animals and Animal Products | III | A | 320 | PART 320—RECORDS, REGISTRATION, AND REPORTS | § 320.7 Reports by consignees of allegedly adulterated or misbranded products; sale or transportation as violations. | FSIS | Whenever the consignee of any product which bears an official inspection legend refuses to accept delivery of such product on the grounds that it is adulterated or misbranded, the consignee shall notify the Inspector in Charge, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, of the kind, quantity, source, and present location of the product and the respects in which it is alleged to be adulterated or misbranded, and it will be a violation of the Act for any person to sell or transport, or offer for sale or transportation, or receive for transportation, in commerce, any such product which is capable of use as human food and is adulterated or misbranded at the time of such sale, transportation, offer, or receipt: Provided, however, That any such allegedly adulterated or misbranded product may be transported to the official establishment from which it had been transported, in accordance with § 325.10 of this subchapter. |
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