cfr_sections
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39 rows where part_number = 1114 sorted by section_id
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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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| 21:21:8.0.1.4.49.1.1.1 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | A | Subpart A—General Provisions | § 1114.1 Scope. | FDA | (a) This part sets forth the procedures and requirements for submitting a premarket tobacco product application (PMTA), the general procedures FDA will follow when evaluating a PMTA, and postmarket reporting requirements. (b) This part does not apply to modified risk tobacco product applications, except that single applications seeking both a marketing granted order under section 910(c) of the Federal Food, Drug, and Cosmetic Act and an order under section 911(g) of the Federal Food, Drug, and Cosmetic Act must satisfy the requirements of this part in addition to the requirements of section 911 of the Federal Food, Drug, and Cosmetic Act. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (d) This part does not apply to “premium” cigars as defined in § 1114.3. | ||||
| 21:21:8.0.1.4.49.1.1.2 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | A | Subpart A—General Provisions | § 1114.3 Definitions. | FDA | [86 FR 55412, Oct. 4, 2021, as amended at 88 FR 16553, Mar. 20, 2023] | For purposes of this part: Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or (2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product, but: (i) Solely controls moisture and/or temperature of a stored tobacco product; or (ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product. Additive means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco, or a pesticide chemical residue in or on raw tobacco or a pesticide chemical. Adverse experience means any unfavorable physical or psychological effect in a person that is temporally associated with the use of or exposure to a tobacco product, whether or not the person uses the tobacco product, and whether or not the effect is considered to be related to the use of or exposure to the tobacco product. Applicant means any person that submits a premarket tobacco product application to receive a marketing granted order for a new tobacco product. Brand means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name(s), identifiable pattern of colors, or any combination of such attributes. Characteristics … | |||
| 21:21:8.0.1.4.49.2.1.1 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | B | Subpart B—Premarket Tobacco Product Applications | § 1114.5 Application submission. | FDA | An applicant may submit a PMTA to demonstrate that a new tobacco product meets the requirements to receive a marketing granted order. A new tobacco product may not be introduced or delivered for introduction into interstate commerce under this part until FDA has issued a marketing granted order for the product. | ||||
| 21:21:8.0.1.4.49.2.1.2 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | B | Subpart B—Premarket Tobacco Product Applications | § 1114.7 Required content and format. | FDA | (a) General. The PMTA must contain sufficient information for FDA to determine whether any of the grounds for marketing denial order specified in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply. The application must contain the following sections: (1) General information (as described in paragraph (c) of this section); (2) Descriptive information (as described in paragraph (d) of this section); (3) Product samples (as described in paragraph (e) of this section); (4) Labeling and description of marketing plans (as described in paragraph (f) of this section); (5) Statement of compliance with 21 CFR part 25 (as described in paragraph (g) of this section); (6) Summary (as described in paragraph (h) of this section); (7) Product formulation (as described in paragraph (i) of this section); (8) Manufacturing (as described in paragraph (j) of this section); (9) Health risk investigations (as described in paragraph (k) of this section); and (10) The effect on the population as a whole (as described in paragraph (l) of this section); (11) Certification statement (as described in paragraph (m) of this section). (b) Format. (1) The application must be submitted using the form(s) that FDA provides, contain a comprehensive index ( i.e., a listing of files and data associated with those files) and table of contents, be well-organized and legible, and be written in English. Documents that have been translated from another language into English ( e.g., original study documents written in a language other than English) must be accompanied by: The original language version of the document, signed a statement by an authorized representative of the manufacturer certifying that the English language translation is complete and accurate, and a brief statement of the qualifications of the person that made the translation. As described in § 1114.49, the applicant must submit the application and all information supporting the application in an electronic format that FDA can process, read, review, and a… | ||||
| 21:21:8.0.1.4.49.2.1.3 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | B | Subpart B—Premarket Tobacco Product Applications | § 1114.9 Amendments. | FDA | (a) General. FDA may request, or an applicant may submit on its own initiative, an amendment to a PMTA containing information that is necessary for FDA complete the review of a pending PMTA. An amendment must include the appropriate form and specify the STN assigned to the original submission and, if submitted other than at FDA's request, the reason for submitting the amendment. An amendment must also include the certification statement set forth in § 1114.7(m), with the appropriate information inserted, and signed by an authorized representative of the applicant. (b) Review of an amendment. Submission of an amendment may affect the timing of review of an amended submission as follows: (1) If the amendment is a major amendment ( e.g., an amendment that contains significant new data from a previously unreported study, detailed new analyses of previously submitted data, or substantial new manufacturing information), FDA will restart the 180-day review period after receipt of the amendment. (2) If FDA requests a minor amendment ( i.e., an amendment that is not a major amendment) and receives a written response submitting the requested amendment, FDA may pause the review period for the number of days elapsed between the date of the request and the date that FDA receives the written response. (c) Failure to respond to amendment request. If FDA requests an amendment and the applicant does not respond within the time period specified in FDA's request, FDA may consider the applicant to have submitted a request to voluntarily withdraw the pending PMTA under § 1114.11 and issue an acknowledgment letter notifying the applicant of the withdrawal. (d) No amendment to closed or withdrawn application. An applicant may not amend an application after FDA has closed the application through an action under § 1114.29 or it has been withdrawn under § 1114.11. | ||||
| 21:21:8.0.1.4.49.2.1.4 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | B | Subpart B—Premarket Tobacco Product Applications | § 1114.11 Withdrawal by applicant. | FDA | (a) An applicant may at any time make a written request using the appropriate form to withdraw a PMTA that FDA has not acted on as described in § 1114.29. The withdrawal request must state: (1) Whether the withdrawal is due to a health concern related to the tobacco product and, if so, a description of those concerns, including the extent, duration, and frequency of the health effects, and what gave rise to the concerns, such as reports of adverse experiences; (2) The application STN; and (3) The name(s) of the new tobacco product that is the subject of the application. (b) An application will be considered withdrawn when FDA issues an acknowledgement letter stating that the application has been withdrawn. (c) The application is an Agency record, even if withdrawn. FDA will retain the withdrawn application under Federal Agency records schedules. The availability of the withdrawn application will be subject to FDA's public information regulation in Part 20 of this chapter. | ||||
| 21:21:8.0.1.4.49.2.1.5 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | B | Subpart B—Premarket Tobacco Product Applications | § 1114.13 Change in ownership of an application. | FDA | An applicant may transfer ownership of a PMTA. At or before the time of transfer, the new owner and the former owner must submit information to FDA using the appropriate form as follows: (a) The new and former owner must sign and submit a notice to FDA stating that all of the former applicant's rights and responsibilities relating to the PMTA have been transferred to the new owner. This notice must identify the name and address of the new owner and the PMTA transferred by tobacco product name(s) and STN. (b) The new owner must sign and submit a notice to FDA containing the following: (1) The new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application and marketing granted order, if applicable; (2) The date that the change in ownership is effective; (3) Either a statement that the new owner has a complete copy of the application, including all amendments, the marketing granted order (if applicable), and any records that are required to be kept under § 1114.45, or a request for a copy of the application, including all amendments, and the modified risk order (if applicable) from FDA's files in accordance with part 20 of this chapter. In accordance with the Freedom of Information Act, FDA will provide a copy of the application to the new owner under the fee schedule in FDA's public information regulations in § 20.45 of this chapter; and (4) A certification that no modifications have been made to the tobacco product since the application, including amendments (if any), was submitted to FDA. | ||||
| 21:21:8.0.1.4.49.2.1.6 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | B | Subpart B—Premarket Tobacco Product Applications | § 1114.15 Supplemental applications. | FDA | (a) Supplemental PMTA submission. Applicants that have received a marketing granted order for a tobacco product may, as an alternative format of submitting an application that meets the content requirements of § 1114.7, submit a supplemental PMTA to seek marketing authorization for modifications to such product, which result in a new tobacco product under section 910(a)(1) of the Federal Food, Drug, and Cosmetic Act. Supplemental PMTAs must include new information concerning modifications that create the new tobacco product but allow the applicant to satisfy the remaining application requirements by cross-referencing applicable content from the previously submitted PMTA for the original tobacco product. Applicants may submit supplemental PMTAs only for modifications that require the submission of limited new information or where specified in a rule under section 907 of the FD&C Act. Except as permitted in a rule under section 907 of the Federal Food, Drug, and Cosmetic Act, an applicant may not submit a supplemental PMTA where: (1) Modifications to the product that result in the new tobacco product require the submission of new information or revisions to the PMTA for the original product to the extent that reviewing a supplemental application for the new tobacco product would be confusing, cumbersome, or otherwise inefficient and submitting a standard PMTA under § 1114.7 would better facilitate review. (2) The marketing granted order for the original tobacco product has been withdrawn; or (3) The marketing granted order for the original tobacco product has been temporarily suspended or is subject to temporary suspension or withdrawal proceedings by FDA, except where authorized in writing by FDA. (b) Required format. The supplemental PMTA must comply with format requirements of § 1114.7(b), except that an applicant must include certain content in a supplemental PMTA by cross-referencing a PMTA, or, where applicable, a supplemental PMTA, for an original tobacco product that is owned by that applicant, and … | ||||
| 21:21:8.0.1.4.49.2.1.7 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | B | Subpart B—Premarket Tobacco Product Applications | § 1114.17 Resubmissions. | FDA | (a) General. An applicant may, as an alternative format of submitting an application that meets the content requirements of § 1114.7 or 1114.15 (if applicable), submit a resubmission to address deficiencies set forth in a marketing denial order. The resubmission must contain new information necessary to address application deficiencies and cross-reference applicable content from the PMTA that received the marketing denial order. An applicant may utilize the resubmission format for the same tobacco product for which FDA issued a marketing denial order or a new tobacco product that results from modifications to the product necessary to address the deficiencies described in a marketing denial order. An applicant may not submit a resubmission when: (1) It incorporates new information or revisions to the PMTA for the original product to the extent that reviewing a resubmission for the new tobacco product would be confusing, cumbersome, or otherwise inefficient and submitting a standard PMTA under § 1114.7 would better facilitate review; or (2) The marketing denial order states that the applicant may not submit a resubmission. (b) Required format. The resubmission must comply with format requirements of § 1114.7(b), except that an applicant must include content in the resubmission by cross-referencing the PMTA, or, where applicable, supplemental PMTA, that received the marketing denial order. An applicant may also include content in a resubmission by cross-reference to a TPMF. FDA will not consider content included by cross-reference to other sources of information outside of the submission. (c) Required content. The resubmission must provide sufficient information for FDA to determine whether any of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply to the application. (1) The application must include the full text of the information described in the following paragraphs: (i) General information that identifies the submission as a resubmission (as described… | ||||
| 21:21:8.0.1.4.49.3.1.1 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | C | Subpart C—FDA Review | § 1114.25 Communication between FDA and applicants. | FDA | During the course of reviewing an application, FDA may communicate with an applicant about relevant matters, including scientific, medical, and procedural issues that arise during the review process and inspections. These communications may take the form of telephone conversations, letters, electronic communications, or meetings, and will be documented in the administrative file in accordance with § 10.65 of this chapter. | ||||
| 21:21:8.0.1.4.49.3.1.2 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | C | Subpart C—FDA Review | § 1114.27 Review procedure. | FDA | (a) Acceptance review. (1) After an applicant submits a PMTA, FDA will perform an initial review of the PMTA to determine whether it may be accepted for further review. FDA may refuse to accept an application that: (i) Does not comply with the applicable format requirements in § 1114.7(b), § 1114.15, or § 1114.17 (as applicable); (ii) Is not administratively complete because it does not appear to contain the information required by § 1114.7 (excluding product samples), § 1114.15 or § 1114.17, as applicable; (iii) Does not pertain to a tobacco product subject to chapter IX of the Federal Food, Drug, and Cosmetic Act (as required by § 1105.10 of this chapter); or (iv) FDA can otherwise refuse to accept under § 1105.10. (2) If FDA accepts an application for further review, FDA will issue an acknowledgement letter to the applicant that specifies the PMTA STN. If FDA determines that it will require product samples as part of the PMTA, it will send instructions on how and where to submit product samples, as described in § 1114.7(e) of this chapter. (3) If FDA refuses to accept an application, FDA will issue a letter to the applicant identifying the deficiencies, where practicable, that prevented FDA from accepting the application. (b) Filing review. (1) After accepting a PMTA, FDA will make a threshold determination of whether the application contains sufficient information to permit a substantive review. FDA may refuse to file a PMTA if any of the following applies: (i) The PMTA does not contain sufficient information required by section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act and by § 1114.7, § 1114.15, or § 1114.17, as applicable, to permit a substantive review of the application; (ii) The application does not contain any substantive information, including information from published literature or bridged from an investigation of another tobacco product, regarding each of the following topics. (A) The health risks of the new tobacco product as described in either § 1114.7(k)(1)(i)(A), (B),… | ||||
| 21:21:8.0.1.4.49.3.1.3 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | C | Subpart C—FDA Review | § 1114.29 FDA action on an application. | FDA | After receipt of an application, FDA will: (a) Refuse to accept the application as described in § 1114.27(a); (b) Issue a letter administratively closing the application; (c) Issue a letter canceling the application if FDA finds that it mistakenly accepted the application or that the application was submitted in error; (d) Refuse to file the application as described in § 1114.27(b); (e) Issue a marketing granted order as described in § 1114.31; or (f) Issue a marketing denial order as described in § 1114.33. | ||||
| 21:21:8.0.1.4.49.3.1.4 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | C | Subpart C—FDA Review | § 1114.31 Issuance of a marketing granted order. | FDA | (a) FDA will issue a marketing granted order if it finds that none of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply. A marketing granted order becomes effective on the date it is issued. (b) FDA may include, as part of the marketing granted order: (1) Restrictions on the sale and distribution of the product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, to the extent that it would be authorized to impose such restrictions under a regulation issued under section 906(d) of the Federal Food, Drug, and Cosmetic Act; (2) Any restrictions on the sales, distribution, advertising, and promotion of the new tobacco product that the applicant proposed to be included as part of a marketing granted order under section 910(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act to support a finding by FDA that permitting the product to be marketed would be appropriate for the protection of the public health; and (3) Requirements to establish and maintain records, and submit postmarket reports under section 910(f) of the Federal Food, Drug and Cosmetic Act in addition to those described in § 1114.41, including but not limited to information such as labeling, advertising, marketing, promotional materials, or marketing plans not previously submitted to FDA. | ||||
| 21:21:8.0.1.4.49.3.1.5 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | C | Subpart C—FDA Review | § 1114.33 Issuance of a marketing denial order. | FDA | (a) Issuance. FDA will issue a marketing denial order if: (1) Upon the basis of the information submitted as part of the application and any other information before FDA with respect to the new tobacco product, FDA finds that any of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply; (2) The applicant does not permit an authorized FDA employee, at a reasonable time and in a reasonable manner, an opportunity to: (i) Inspect the facilities and controls described in the application; or (ii) Have access to, copy, and verify all records pertinent to the application, which results in FDA finding that one or more of the grounds for denial specified in section 910(c)(2) of the Federal Food, Drug and Cosmetic Act apply. (b) Description of deficiencies. The marketing denial order will, where practicable, identify measures to remove the application from deniable form. | ||||
| 21:21:8.0.1.4.49.3.1.6 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | C | Subpart C—FDA Review | § 1114.35 Withdrawal of a marketing granted order. | FDA | (a) Grounds for withdrawal. FDA will withdraw a marketing granted order for a new tobacco product issued under this part if FDA determines that: (1) Any of the grounds for withdrawal under section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act apply; or (2) Any postmarket requirement imposed by the marketing granted order or by this part has not been met, which results in FDA finding that one or more of the grounds for withdrawal specified in section 910(d)(1) of the Federal Food, Drug and Cosmetic Act apply. (b) Advice and other information. (1) FDA may seek advice on scientific matters from any appropriate FDA advisory committee in deciding whether to withdraw a marketing granted order. (2) FDA may use information other than that submitted by the applicant in deciding whether to withdraw a marketing granted order. (c) Informal hearing. Prior to withdrawing a marketing granted order, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under part 16 of this chapter. (d) Order issuance. If the applicant does not request a hearing or, if after the part 16 hearing is held, the Agency decides to proceed with the withdrawal, FDA will issue to the holder of the marketing granted order an order withdrawing the marketing granted order for the new tobacco product. (e) Public notice. FDA will give the public notice of an order withdrawing a marketing granted order for a tobacco product and will announce the basis of the withdrawal. | ||||
| 21:21:8.0.1.4.49.3.1.7 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | C | Subpart C—FDA Review | § 1114.37 Temporary suspension of a marketing granted order. | FDA | (a) FDA will temporarily suspend a marketing granted order if FDA determines that there is a reasonable probability that the continued distribution of such tobacco product would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market. (b) Before temporarily suspending a marketing granted order of a tobacco product, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under part 16 of this chapter. (c) If, after offering the holder of the marketing granted order an opportunity for a part 16 hearing, the Agency decides to proceed with the temporary suspension, FDA will issue an order temporarily suspending the marketing granted order for a tobacco product. (d) After issuing an order temporarily suspending the marketing granted order, FDA will proceed expeditiously to withdraw the marketing granted order for the tobacco product. | ||||
| 21:21:8.0.1.4.49.4.1.1 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | D | Subpart D—Postmarket Requirements | § 1114.39 Postmarket changes. | FDA | A marketing granted order authorizes the marketing of a new tobacco product in accordance with the terms of the order. Prior to the introduction or delivery for introduction into interstate commerce of a new tobacco product that results from modification(s) to the product, an applicant must submit a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and obtain a marketing granted order for the new tobacco product, unless the new tobacco product can be legally marketed through another premarket pathway. | ||||
| 21:21:8.0.1.4.49.4.1.2 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | D | Subpart D—Postmarket Requirements | § 1114.41 Reporting requirements. | FDA | (a) Required reports. Each applicant that receives a marketing granted order must submit to FDA all information required by the terms of the marketing granted order and by this section as described below. Each postmarket report must be well-organized, legible, and written in English. Documents that have been translated from another language into English ( e.g., original study documents written in a language other than English) must be accompanied by the original language version of the document, a signed statement by an authorized representative of the manufacturer certifying that the English language translation is complete and accurate, and a brief statement of the qualifications of the person that made the translation. (1) Periodic reports. Each applicant must submit a periodic report to the Center for Tobacco Products (CTP) within 60 calendar days of the reporting dates specified in the applicant's marketing granted order for the life of the order and as may be required for the submission of a supplemental PMTA under § 1114.15. The report must include the following: (i) A cover letter that contains the PMTA STN, tobacco product name(s) (including the original name described in the PMTA if different), company name, date of report, and reporting period; (ii) A description of all changes made to the manufacturing, facilities, or controls during the reporting period, including: (A) A comparison of each change to what was described in the PMTA; (B) The rationale for making each change and, if any, a listing of any associated changes; and (C) The basis for concluding that each change does not result in a new tobacco product that is outside the scope of the marketing granted order and will not result in a finding that the marketing granted order must be withdrawn or temporarily suspended under section 910(d) of the Federal Food, Drug, and Cosmetic Act; (iii) An inventory of ongoing and completed studies about the tobacco product conducted by, or on behalf of, the applicant that are within the scope of § … | ||||
| 21:21:8.0.1.4.49.5.1.1 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | E | Subpart E—Miscellaneous | § 1114.45 Record retention. | FDA | (a) Record retention by the applicant. (1) Each applicant that receives a marketing granted order must maintain all records necessary to facilitate a determination of whether there are or may be grounds to withdraw or temporarily suspend the marketing granted order, including records related to both the application and postmarket reports, and ensure that such records remain readily available to the Agency upon request (including where records are maintained by a third party on an applicant's behalf). These records include, but are not limited to: (i) All documents submitted to FDA as part of an application, periodic postmarket reports, and adverse experience reports; (ii) All documentation demonstrating whether each: (A) Nonclinical laboratory study was conducted in accordance with good laboratory practices that support the reliability of the results, such as the records described in part 58 of this chapter; and (B) Clinical investigator has any financial conflicts of interest that may be a source of bias, such as the documentation described in part 54 of this chapter; (iii) All other documents generated during the course of a study necessary to substantiate the study results, including: (A) Communications related to the investigation between the investigator and the sponsor, the monitor, or FDA; and (B) All source data for human subject and nonclinical investigations included in the application and postmarket reports, including records of each study subject's case history and exposure to tobacco products used in the investigation, including case report forms, progress notes, hospital records, clinical charts, X-rays, lab reports, and subject diaries; and (iv) A list of each complaint, and a summary and analysis of all complaints, associated with the tobacco product reported to the applicant; (2) These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. Documents that have been translated from another lang… | ||||
| 21:21:8.0.1.4.49.5.1.2 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | E | Subpart E—Miscellaneous | § 1114.47 Confidentiality. | FDA | (a) General. FDA will determine the public availability of any part of an application and other content related to such an application, including all data and information submitted with or incorporated by reference in the application, under this section and part 20 of this chapter. (b) Confidentiality of data and information prior to an order. Prior to issuing an order under this part: (1) FDA will not publicly disclose the existence of an application unless: (i) The applicant has publicly disclosed or acknowledged (as such disclosure is defined in § 20.81 of this chapter), or has authorized FDA in writing to publicly disclose or acknowledge, that the applicant has submitted an application to FDA; or (ii) FDA refers the application to TPSAC. (2) Except as described in paragraph (b)(4) of this section, FDA will not disclose the existence or contents of an FDA communication with an applicant regarding its application except to the extent that the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence or contents of that particular FDA communication. (3) Except as described in paragraph (b)(4) of this section, FDA will not disclose the existence or contents of information contained in an application unless the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence or contents of that particular information. If the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence or contents of that particular information contained in an application, FDA may disclose the existence or contents of that particular information. (4) If FDA refers an application to TPSAC, the contents of the application will be available for public disclosure, except information that is exempt from disclosure under part 20 of this chapter. (c) Disclosure of data and information after issuance of a marketing granted o… | ||||
| 21:21:8.0.1.4.49.5.1.3 | 21 | Food and Drugs | I | K | 1114 | PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS | E | Subpart E—Miscellaneous | § 1114.49 Electronic submission. | FDA | (a) Electronic format requirement. Applicants submitting any documents to the Agency under this part must provide all required information to FDA using the Agency's electronic system, except as provided in paragraph (b) of this section. The application and all supporting information must be submitted in an electronic format that FDA can process, review, and archive. (b) Waivers from electronic format requirement. An applicant may submit a written request, that is legible and in English, to the Center for Tobacco Products asking that FDA waive the requirement for electronic format and content. Waivers will be granted if use of electronic means is not reasonable for the applicant. To request a waiver, applicants can send the written request to the address included on our website ( www.fda.gov/tobacco-products ). The request must include the following information: (1) The name and address of the applicant, a list of individuals authorized by the applicant to serve as the contact person and contact information. If the applicant has submitted a PMTA previously, the regulatory correspondence should also include any identifying information about the previous submission. (2) A statement that creation and/or submission of information in electronic format is not reasonable for the applicant, and an explanation of why creation and/or submission in electronic format is not reasonable. This statement must be signed by the applicant or by a representative who is authorized to make the declaration on behalf of the applicant. (c) Paper submission. An applicant who has obtained a waiver from filing electronically must send a written application through the Document Control Center to the address provided in the FDA documentation granting the waiver. | ||||
| 49:49:8.1.1.2.44.1.7.1 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | A | Subpart A—General Rules of Evidence | § 1114.1 Admissibility. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996] | Any evidence which is sufficiently reliable and probative to support a decision under the provisions of the Administrative Procedure Act, or which would be admissible under the general statutes of the United States, or under the rules of evidence governing proceedings in matters not involving trial by jury in the courts of the United States, will be admissible in hearings before the Board. The rules of evidence will be applied in any proceeding to the end that necessary and proper evidence will be conveniently, inexpensively, and speedily produced, while preserving the substantial rights of the parties. | |||
| 49:49:8.1.1.2.44.1.7.2 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | A | Subpart A—General Rules of Evidence | § 1114.2 Official records. | STB | An official record or an entry therein, when admissible for any purpose, may be evidenced by an official publication thereof or by a copy attested by the officer having the legal custody of the record, or by a deputy, and accompanied with a certificate that such officer has the custody. If the office in which the record is kept is within the United States or within a territory or insular possession subject to the dominion of the United States, the certificate may be made by a judge of a court of record of the district or political subdivision in which the record is kept, authenticated by the seal of the court, or may be made by any public officer having a seal of office and having official duties in the district or political subdivision in which the record is kept, authenticated by the seal of his office. If the office in which the record is kept is in a foreign state or country, the certificate may be made by a secretary of embassy or legation, consul general, consul, vice consul, or consular agent or by officer in the foreign service of the United States stationed in the foreign state or country in which the record is kept, and authenticated by the seal of his office. A written statement signed by an officer having the custody of an official record or by his deputy that after diligent search no record or entry of a specified tenor is found to exist in the records of his office, accompanied by a certificate as above provided, is admissible as evidence that the records of this office contain no such record or entry. This section does not prevent the proof of official records or of entry or lack of entry therein or official notice thereof by a method authorized by any applicable statute or by the rules of evidence. | ||||
| 49:49:8.1.1.2.44.1.7.3 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | A | Subpart A—General Rules of Evidence | § 1114.3 Admissibility of business records. | STB | Any writing or record, whether in the form of an entry in a book or otherwise, made as a memorandum or record of any act, transaction, occurrence, or event, will be admissible as evidence thereof if it appears that it was made in the regular course of business, and that it was the regular course of business to make such memorandum or record at the time such record was made, or within a reasonable time thereafter. | ||||
| 49:49:8.1.1.2.44.1.7.4 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | A | Subpart A—General Rules of Evidence | § 1114.4 Documents in Board's files. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996] | If a party offers in evidence any matter contained in a report or other document open to public inspection in the files of the Board, such report or other document need not be made available at the hearing. | |||
| 49:49:8.1.1.2.44.1.7.5 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | A | Subpart A—General Rules of Evidence | § 1114.5 Records in other Board proceedings. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996] | If any portion of the record before the Board in any proceeding other than the proceeding at issue is offered in evidence, a true copy will be presented for the record. | |||
| 49:49:8.1.1.2.44.1.7.6 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | A | Subpart A—General Rules of Evidence | § 1114.6 Official notice of corroborative material. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996] | The Board or a hearing officer may take notice of official records, records in other Board proceedings, or other materials which are otherwise subject to specific rules governing admissibility regardless of compliance with the full technical provisions of such rules, where the admissibility of the evidence is for purposes of corroboration of testimony presented or to evaluate the credibility of testimony or allegations made in proceedings where the public interest is not otherwise adequately represented by counsel capable of fully complying with such rules. | |||
| 49:49:8.1.1.2.44.1.7.7 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | A | Subpart A—General Rules of Evidence | § 1114.7 Exhibits. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996] | Whenever practical the sheets of each exhibit and the lines of each sheet should be numbered. If the exhibit consists of five or more sheets, the first sheet or title-page should be confined to a brief statement of what the exhibit purports to show with reference by sheet and line to illustrative or typical examples contained therein. The exhibit should bear an identifying number, letter, or short title which will readily distinguish it from other exhibits offered by the same party. It is desirable that, whenever practicable, evidence should be condensed into tables. Whenever practicable, especially in proceedings in which it is likely that many documents will be offered, all the documents produced by a single witness should be assembled and bound together, suitably arranged and indexed, so that they may be identified and offered as one exhibit. Exhibits should not be argumentative and should be limited to statements of facts, and be relevant and material to the issue, which can better be shown in that form than by oral testimony. | |||
| 49:49:8.1.1.2.44.2.7.1 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.21 Applicability; general provisions. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996; 72 FR 51377, Sept. 7, 2007; 81 FR 8854, Feb. 23, 2016; 82 FR 57381, Dec. 5, 2017; 88 FR 319, Jan. 4, 2023; 90 FR 24080, June 6, 2025] | (a) When discovery is available. (1) Parties may obtain discovery under this subpart regarding any matter, not privileged, which is relevant to the subject matter involved in a proceeding other than an informal proceeding. For the purpose of this subchapter, informal proceedings are those not required to be determined on the record after hearing and include informal complaints and all proceedings assigned for initial disposition to employee boards under § 1011.5. (2) It is not grounds for objection that the information sought will be inadmissible as evidence if the information sought appears reasonably calculated to lead to the discovery of admissible evidence. (3) In cases using the simplified standards Three-Benchmark method, the number of discovery requests that either party can submit is limited as set forth in §§ 1114.22, 1114.26, and 1114.30, absent advance authorization from the Board. (b) How discovery is obtained. All discovery procedures may be used by parties without filing a petition and obtaining prior Board approval. (c) Protective conditions. Upon motion by any party, by the person from whom discovery is sought, or by any person with a reasonable interest in the data, information, or material sought to be discovered and for good cause shown, any order which justice requires may be entered to protect a party or person from annoyance, embarrassment, oppression, or undue burden or expense, or to prevent the raising of issues untimely or inappropriate to the proceeding. Relief through a protective order may include one or more of the following: (1) That the discovery not be had; (2) That the discovery may be had only on specified terms and conditions, including a designation of the time and place; (3) That the discovery may be had only upon such terms and conditions as the Board may impose to insure financial responsibility indemnifying the party or person against whom discovery is sought to cover the reasonable expenses incurred; (4) That the discovery may be had only by a method other t… | |||
| 49:49:8.1.1.2.44.2.7.10 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.30 Production of documents and records and entry upon land for inspection and other purposes. | STB | [61 FR 52713, Oct. 8, 1996, as amended at 72 FR 51377, Sept. 7, 2007; 73 FR 31034, May 30, 2008] | (a) Scope. Any party may serve on any other party a request: (1) To produce and permit the party making the request to inspect any designated documents (including writings, drawings, graphs, charts, photographs, phonograph records, tapes, and other data compilations from which information can be obtained, translated, if necessary, with or without the use of detection devices into reasonably usable form), or to inspect and copy, test, or sample any tangible things which are in the possession, custody, or control of the party upon whom the request is served, but if the writings or data compilations include privileged or proprietary information or information the disclosure of which is proscribed by the Act, such writings or data compilations need not be produced under this rule but may be provided pursuant to § 1114.26(b) of this part; or (2) To permit, subject to appropriate liability releases and safety and operating considerations, entry upon designated land or other property in the possession or control of the party upon whom the request is served for the purpose of inspecting and measuring, surveying, photographing, testing, or sampling the property or any designated object or operation thereon. (b) Procedure. Any request filed pursuant to this rule should set forth the items to be inspected either by individual item or by category and describe each item and category with reasonable particularity. The request should specify a reasonable time, place, and manner of making the inspection and performing the related acts. (c) Limitation under simplified standards. In a case using the Three-Benchmark methodology, each party is limited to ten document requests (including subparts) absent advance authorization from the Board. (d) Agreements containing interchange commitments. In any proceeding involving the reasonableness of provisions related to an existing rail carrier sale or lease agreement that serve to induce a party to the agreement to interchange traffic with another party to the agreement, rather… | |||
| 49:49:8.1.1.2.44.2.7.11 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.31 Failure to respond to discovery. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996; 68 FR 17313, Apr. 9, 2003; 69 FR 58366, Sept. 30, 2004; 72 FR 51377, Sept. 7, 2007; 74 FR 52908, Oct. 15, 2009; 82 FR 57381, Dec. 5, 2017; 83 FR 15079, Apr. 9, 2018; 88 FR 319, Jan. 4, 2023; 90 FR 24080, June 6, 2025; 91 FR 4854, Feb. 3, 2026] | (a) Failure to answer. If a deponent fails to answer or gives an evasive answer or incomplete answer to a question propounded under § 1114.24(a), or a party fails to answer or gives evasive or incomplete answers to written interrogatories served pursuant to § 1114.26(a), the party seeking discovery may apply for an order compelling an answer by motion filed with the Board and served on all parties and deponents. Such motion to compel an answer must be filed with the Board and served on all parties and deponents. Such motion to compel an answer must be filed with the Board within 10 days after the failure to obtain a responsive answer upon deposition, or within 10 days after expiration of the period allowed for submission of answers to interrogatories. On matters relating to a deposition on oral examination, the proponent of the question may complete or adjourn the examination before he applies for an order. (1) Reply to motion to compel generally. Except in rate cases to be considered under the stand-alone cost methodology or simplified standards, the time for filing a reply to a motion to compel is governed by 49 CFR 1104.13. (2) Motions to compel in stand-alone cost and simplified standards rate cases. (i) Motions to compel in stand-alone cost and simplified standards rate cases must include a certification that the movant has in good faith conferred or attempted to confer with the person or party failing to answer discovery to obtain it without Board intervention. (ii) In a rate case to be considered under the stand-alone cost or simplified standards methodologies, a reply to a motion to compel must be filed with the Board within 10 days of when the motion to compel is filed. (3) Conference with parties on motion to compel. Within 5 business days after the filing of a reply to a motion to compel in a rate case to be considered under the stand-alone cost methodology or under the simplified standards, Board staff may convene a conference with the parties to discuss the dispute, attempt to narrow the … | |||
| 49:49:8.1.1.2.44.2.7.2 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.22 Deposition. | STB | [61 FR 52713, Oct. 8, 1996, as amended at 72 FR 51377, Sept. 7, 2007] | (a) Purpose. The testimony of any person, including a party, may be taken by deposition upon oral examination. (b) Request. A party requesting to take a deposition and perpetuate testimony: (1) Should notify all parties to the proceeding and the person sought to be deposed; and (2) Should set forth the name and address of the witness, the place where, the time when, the name and office of the officer before whom, and the cause or reason why such deposition will be taken. (c) Limitation under simplified standards. In a case using the Three-Benchmark methodology, each party is limited to one deposition absent advance authorization from the Board. | |||
| 49:49:8.1.1.2.44.2.7.3 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.23 Depositions; location, officer, time, fees, absence, disqualification. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996] | (a) Where deposition should be taken. Unless otherwise ordered or agreed to by stipulation, depositions should be taken in the city or municipality where the deponent is located. (b) Officer before whom taken. Within the United States or within a territory or insular possession subject to the dominion of the United States, depositions should be taken before an officer authorized to administer oaths by the laws of the United States or of the place where the examination is held. Within a foreign country, depositions may be taken before an officer or person designated by the Board or agreed upon by the parties by stipulation in writing to be filed with the Board. (c) Fees. A witness whose deposition is taken pursuant to these rules and the officer taking same, unless he be employed by the Board, shall be entitled to the same fee paid for like service in the courts of the United States, which fee should be paid by the party at whose instance the deposition is taken. (d) Failure to attend or to serve subpoena; expenses. (1) If the party who filed a petition for discovery fails to attend and proceed with the taking of the deposition and another party attends in person or by representative pursuant to an order of the Board granting discovery the Board may order the party who filed the petition to pay to such other party the reasonable expenses incurred by him and his representative in so attending, including reasonable attorney's fees. (2) If the party who filed a petition for discovery fails to serve a subpoena upon the witness and the witness because of such failure does not attend, and if another party attends in person or by representative because he expects the deposition of the witness to be taken, the Board may order the party who filed the petition to pay to such other party the reasonable expenses incurred by him and his representative in so attending, including reasonable attorney's fees. (e) Disqualification for interest. No deposition should be taken before a person who is a relative or employ… | |||
| 49:49:8.1.1.2.44.2.7.4 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.24 Depositions; procedures. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996; 74 FR 52908, Oct. 15, 2009; 81 FR 8854, Feb. 23, 2016; 88 FR 319, Jan. 4, 2023; 91 FR 4854, Feb. 3, 2026] | (a) Examination. Examination and cross-examination of witnesses should proceed as permitted at a hearing and should be limited to the subject matter specified in the order granting discovery. All objections made at the time of the examination to the qualifications of the officer taking the deposition, or to the manner of taking it, or to the evidence presented, or to the conduct of any party, and any other objection to the proceedings, should be noted by the officer upon the deposition. Evidence objected to should be taken subject to the objections. In lieu of participating in the oral examination, parties may serve written questions in a sealed envelope on the party taking the deposition, and shall transmit them to the officer, who shall open the sealed envelope, propound the questions to the witness, and record the answers verbatim. (b) Use of depositions. At the hearings, any part or all of a deposition, so far as admissible under the rules of evidence, may be used against any party who was present or represented at the taking of the deposition or who had due notice thereof, in accordance with any one of the following provisions: (1) Any deposition may be used by any party for the purpose of contradicting or impeaching the testimony of the deponent as a witness. (2) The deposition of a party or of anyone who at the time of taking the deposition was an officer, director, or managing agent, or a person designated to testify on behalf of a public or private corporation, partnership, association or governmental agency (other than this Board, except in those instances where the Board itself is a party to the proceeding) which is a party, may be used by an adverse party for any purpose. (3) The deposition of a witness, whether or not a party, may be used by any party for any purpose if the presiding officer or Board finds: (i) That the witness is dead; or (ii) That the witness is at a greater distance than 100 miles from the place of hearing or is out of the United States, unless it appears that the absenc… | |||
| 49:49:8.1.1.2.44.2.7.5 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.25 Effect of errors and irregularities in depositions. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 81 FR 8854, Feb. 23, 2016] | (a) As to disqualification of officer. Objection to taking a deposition because of disqualification of the officer before whom it is to be taken is waived unless made before the taking of the deposition begins or as soon thereafter as the disqualification becomes known or could be discovered with reasonable diligence. (b) As to taking of deposition. (1) Objections to the competency of a witness or to the competency, relevancy, or materiality of testimony are not waived by failure to make them before or during the taking of the deposition, unless the ground of the objection is one which might have been obviated or removed if presented at that time. (2) Errors and irregularities occurring at the oral examination in the manner of taking the deposition, in the form of the questions or answers in the oath or affirmation, or in the conduct of parties, and errors of any kind which might be obviated, removed, or cured if promptly presented, are waived unless reasonable objection thereto is made at the taking of the deposition. (c) As to completion and return of deposition. Objections to errors and irregularities in the manner in which the testimony is transcribed or the deposition is prepared, signed, certified, sealed, endorsed, transmitted, filed, or otherwise dealt with by the officer under §§ 1114.23 and 1114.24 are waived unless a motion to suppress the deposition or some part thereof is made with reasonable promptness after such defect is, or with due diligence might have been, ascertained. | |||
| 49:49:8.1.1.2.44.2.7.6 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.26 Written interrogatories to parties. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996; 72 FR 51377, Sept. 7, 2007; 81 FR 8855, Feb. 23, 2016] | (a) Availability; procedures for use. Subject to the provisions of § 1114.21(a), any party may serve upon any other party written interrogatories to be answered by the party served, or if the party served is a public or private corporation, partnership, association, or Governmental agency (other than this Board, except in those instances where the Board itself is a party to the proceeding), by any officer or agent, who shall furnish such information as is available to the party. Each interrogatory should be answered separately and fully in writing, unless it is objected to, in which event the reasons for objection should be stated in lieu of an answer. The answers are to be signed by the person making them and subscribed by an appropriate verification generally in the form prescribed in § 1112.9. Objections are to be signed by the representative or counsel making them. The person upon whom the interrogatories have been served shall serve a copy of the answers and objections within the time period designated by the party submitting the interrogatories, but not less than 15 days after the service thereof. (b) Option to produce business records. Where the answer to an interrogatory may be derived or ascertained from the business records of the party upon whom the interrogatory has been served or from an examination, audit, or inspection of such business records or from a compilation, abstract, or summary based thereon, and the burden of deriving or ascertaining the answer is substantially the same for the party serving the interrogatory as for the party served, it is a sufficient answer to such interrogatory to specify the records from which the answer may be derived or ascertained and to afford to the party serving the interrogatory reasonable opportunity to examine, audit, or inspect such records and to make copies thereof, or compilation, abstracts, or summaries therefrom. If information sought is contained in computer runs, punchcards, or tapes which also contain privileged or proprietary information or inf… | |||
| 49:49:8.1.1.2.44.2.7.7 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.27 Request for admission. | STB | [47 FR 49562, Nov. 1, 1982, as amended at 61 FR 52713, Oct. 8, 1996; 81 FR 8855, Feb. 23, 2016] | (a) Availability; procedures for use. Subject to the provisions of § 1114.21(a), a party may serve upon any other party a written request for the admission, for purposes of the pending proceeding only, of the truth of any matters within the scope of § 1114.21 set forth in the request, including the genuineness of any documents described in the request for admission. Copies of documents should be served with the request unless they have been or are otherwise furnished or made available for inspection and copying. Each matter of which an admission is requested should be separately set forth. The matter is admitted unless, within a period designated in the request, not less than 15 days after service thereof, the party to whom the request is directed serves upon the party requesting the admission a written answer or objection addressed to the matter, signed by the party or his representative or counsel. If objection is made, the reasons therefor should be stated. The answer should specifically deny the matter or set forth in detail the reasons why the answering party cannot truthfully admit or deny the matter. A denial should fairly meet the substance of the requested admission, and when good faith requires that a party qualify his answer or deny only a part of the matter of which an admission is requested, he shall specify so much of it as is true and qualify or deny the remainder. An answering party may not give lack of information or knowledge as a reason for failure to admit or deny unless he states that he has made reasonable inquiry and that the information known or readily obtainable by him is insufficient to enable him to admit or deny. A party who considers that a matter of which an admission has been requested presents a genuine issue for hearing may not, on that ground alone, object to the request; he may, subject to the provisions of § 1114.31, deny the matter or set forth reasons why he cannot admit or deny it. (b) Effect of admission. Any matter admitted under this rule is conclusively established… | |||
| 49:49:8.1.1.2.44.2.7.8 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.28 Depositions, requests for admission, written interrogatories, and responses thereto: inclusion in record. | STB | At the oral hearing, or upon the submission of statements under the modified procedure, depositions, requests for admission and written interrogatories, and respective responses may be offered in evidence by the party at whose instance they were taken. If not offered by such party, they may be offered in whole or in part by any other party. If only part of a deposition, request for admission or written interrogatory, or response thereto is offered in evidence by a party, any other party (where the matter is being heard orally) may require him to introduce all of it which is relevant to the part introduced, and any party may introduce any other parts. Such depositions, requests for admission and written interrogatories, and responses thereto should be admissible in evidence subject to such objections as to competency of the witness, or competency, relevancy, or materiality of the testimony as were noted at the time of their taking or are made at the time they are offered in evidence. | ||||
| 49:49:8.1.1.2.44.2.7.9 | 49 | Transportation | X | B | 1114 | PART 1114—EVIDENCE; DISCOVERY | B | Subpart B—Discovery | § 1114.29 Supplementation of responses. | STB | A party who has responded to a request for discovery with a response that was complete when made is under a duty to supplement his response to include information thereafter acquired in the following instances: (a) A party is under a duty seasonably to supplement his response with respect to any question directly addressed to: (1) The identity and locations of persons having knowledge of discoverable matters, and (2) The identity of each person expected to be called as an expert witness at the hearing, the subject matter on which he is expected to testify, and the substance of his testimony. (b) A party who knows or later learns that his response is incorrect is under a duty seasonably to correct his response. (c) A duty to supplement responses may be imposed by order, agreement of the parties, or at any time prior to the hearing or the submission of verified statements under the modified procedure through new requests for supplementation of prior responses. |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);