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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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| 15:15:2.1.1.1.5.0.1.1 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.1 Background and purpose. | ITA | The regulations in this part are issued under the authority of Pub. L. 91-269 (84 Stat. 271, 22 U.S.C. 2801 et seq. ) which establishes an orderly procedure for Federal Government recognition of, and participation in, international expositions to be held in the United States. The Act provides, inter alia, that Federal recognition of an exposition is to be granted upon a finding by the President that such recognition will be in the national interest. In making this finding, the President is directed to consider, among other factors, a report from the Secretary of Commerce as to the purposes and reasons for an exposition and the extent of financial and other support to be provided by the State and local officials and business and community leaders where the exposition is to be held, and a report by the Secretary of State to determine whether the exposition is qualified for registration under Bureau of International Expositions (BIE) rules. The BIE is an international organization established by the Paris Convention of 1928 (T.I.A.S. 6548 as amended by T.I.A.S. 6549) to regulate the conduct and scheduling of international expositions in which foreign nations are officially invited to participate. The BIE divides international expositions into different categories and types and requires each member nation to observe specified minimum time intervals in scheduling each of these categories and types of expositions. 1 Under BIE rules, member nations may not ordinarily participate in an international exposition unless such exposition has been approved by the BIE. The United States became a member of the BIE on April 30, 1968, upon ratification of the Paris Convention by the U.S. Senate (114 Cong. Rec. 11012). 1 The BIE defines a General Exposition of the First Category as an exposition dealing with progress achieved in a particular field applying to several branches of human activity at which the invited countries are obligated to construct national pavilions. A General Exposition of the Secondary Category is a s… | ||||||
| 15:15:2.1.1.1.5.0.1.2 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.2 Definitions. | ITA | [40 FR 34107, Aug. 14, 1975. Redesignated and amended at 46 FR 57457, Nov. 24, 1981] | For the purpose of this part, except where the context requires otherwise: (a) Act means Pub. L. 91-269. (b) Secretary means the Secretary of Commerce. (c) Commissioner General means the person appointed to act as the senior Federal official for the exposition as required by BIE rules and regulations. (d) Director means the Director of the International Expositions Staff, Office of the Deputy Assistant Secretary for Export Development, International Trade Administration, Department of Commerce. (e) Applicant means a State, County, municipality, a political subdivision of the foregoing, private non-profit or not-for-profit organizations, or individuals filing an application with the Director seeking Federal recognition of an international exposition to be held in the United States. (f) State means one of the several States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands. (g) Exposition means an international exposition proposed to be held in the United States for which an application has been filed with the Director seeking Federal recognition under the Act; which proposes to invite more than one foreign country to participate; and, which would exceed three weeks in duration. Any event under three weeks in duration is not considered an international exposition under BIE rules. | |||||
| 15:15:2.1.1.1.5.0.1.3 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.3 Applications for Federal recognition. | ITA | [40 FR 34107, Aug. 14, 1975. Redesignated and amended at 46 FR 57457, Nov. 24, 1981] | (a) Applications for Federal recognition of an exposition shall be filed with, and all official communications in connection therewith addressed to, the International Expositions Staff, International Trade Administration, Department of Commerce, Washington, DC 20230. (b) Every application, exhibit, or enclosure, except where specifically waived by the Director, shall be in quadruplicate, duly authenticated and referenced. (c) Every application shall be in letter form and shall contain the date, address, and official designation of the applicant and shall be signed by an authorized officer or individual. (d) Every application, except where specifically waived by the Director, shall be accompanied by the following exhibits: 1. Exhibit No. 1. A study setting forth in detail the purpose for the exposition, including any historical, geographic, or other significant event of the host city, State, or region related to the exposition. 2. Exhibit No. 2. An exposition plan setting forth in detail (i) the theme of the exposition and the “storyline” around which the entire exposition is to be developed; (ii) whatever preliminary architectural and design plans are available on the physical layout of the site plus existing and projected structures; (iii) the type of participation proposed in the exposition (e.g., foreign and domestic exhibits); (iv) cultural, sports, and special events planned; (v) the proposed BIE category of the event and evidence of its conformity to the regulations of the BIE (a copy of these regulations can be obtained from the Director upon request); (vi) the proposed steps that will be taken to protect foreign exhibitors under the BIE model rules and regulations and (vii) in writing commit its organization to the completion of the exposition. 3. Exhibit No. 3. Documentary evidence of State, regional and local support (e.g., letters to the applicant from business and civic leadership of the region, pledging assistance and/or financing; State and/or municipal resolutions, acts, or appr… | |||||
| 15:15:2.1.1.1.5.0.1.4 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.4 Action on application. | ITA | (a) Upon receipt of an application, the Director will analyze the application and all accompanying exhibits to insure compliance with the provisions of § 310.3 and report his findings with respect thereto to the Secretary. (b) If more than one applicant applies for Federal recognition for expositions to be held within three years or less of each other, the applications will be reviewed concurrently by the Director. The following standards will be considered in determining which if any of the competing applicants will be recommended for Federal recognition: (1) The order of receipt of the applications by the Director, complete with all exhibits required by § 310.3. (2) The financial plans of the applications. Primary consideration will be given to those applications which do not require Federal financing for exposition development. This does not extend to funding for a Federal pavilion, if one is desired. (3) The relative merit of the applications in terms of their qualifications as tourism destination sites, both with respect to existing facilities and those facilities planned for the proposed exposition. If necessary, to assist in making this determination, the Director will appoint a panel of travel industry experts representing tour developers, the transportation, entertainment and hotel/motel industries for the purpose of studying the competing applications and reporting to the Director its views as to which proposed site best meets the above criteria. If such a panel is deemed necessary, the provisions of the Federal Advisory Committee Act (86 Stat. 770, 5 U.S.C. App. I) will be applicable. (c) In analyzing the applications, the Director may hold public hearings with the objective of clarifying issues that might be raised by the application. If desired, the Director may utilize the services of an examiner. (d) If the Director, in his discretion, decides to hold a public hearing, notice of such hearing shall be published in the Federal Register, and a copy of the notice shall be furnished to local new… | ||||||
| 15:15:2.1.1.1.5.0.1.5 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.5 Report of the Secretary on Federal recognition. | ITA | If the Director's report recommends Federal recognition, the Secretary, within a reasonable time, shall submit a report to the President. (a) The Secretary's report shall include: (1) An evaluation of the purposes and reasons for the exposition; and (2) a determination as to whether guaranteed financial and other support has been secured by the exposition from affected State and local governments and from business and civic leaders of the region and others in amounts sufficient to assure the successful development and progress of the exposition. (b) Based on information from, and coordination with the Department of Commerce the Secretary of State shall also file a report with the President that the exposition qualifies for recognition by the BIE. | ||||||
| 15:15:2.1.1.1.5.0.1.6 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.6 Recognition by the President. | ITA | If the President concurs in the favorable reports from the Secretaries of State and Commerce, he may grant Federal recognition to the exposition by indicating his concurrence to the two Secretaries and authorizing them to seek BIE registration. | ||||||
| 15:15:2.1.1.1.5.0.1.7 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.7 Statement for Federal participation. | ITA | If Federal participation in the exposition, as well as Federal recognition thereof is desired, the applicant shall in a statement to the Director outline the nature of the Federal participation envisioned, including whether construction of a Federal pavilion is contemplated. (It should be noted, however, that before Federal participation can be authorized by the Congress under the Act, the exposition must have (i) met the criteria for Federal recognition and be so recognized, and (ii) been registered by the BIE. Although applicants need not submit such a statement until these prerequisites are satisfied, they are encouraged to do so.) Where the desired Federal participation includes a request for construction of a Federal pavilion, the statement shall be accompanied by the following exhibits: 1. Exhibit No. 1. A survey drawing of the proposed Federal pavilion site, showing its areas and boundaries, its grade elevations, and surface and subsoil conditions. 2. Exhibit No. 2. Evidence of resolutions, statutes, opinions, etc., as to the applicant's ability to convey by deed the real property comprising the proposed Federal pavilion site in fee-simple and free of liens and encumbrances to the Federal Government. The only consideration on the part of the Government for the conveyance of the property shall be the Government's commitment to participate in the exposition. 3. Exhibit No. 3. A certified copy of the building code which would be applicable should a pavilion be constructed. 4. Exhibit No. 4. An engineering drawing showing the accessibility of the proposed pavilion site to utilities (e.g., sewerage, water, gas, electricity, etc.). 5. Exhibit No. 5. A statement setting forth the security and maintenance and arrangements which the applicant would undertake (and an estimate of their cost) while a pavilion is under construction. 6. Exhibit No. 6. A study pursuant to Executive Order 11296 of August 10, 1966, entitled “Evaluation of flood hazard in locating Federally owned or fin… | ||||||
| 15:15:2.1.1.1.5.0.1.8 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.8 Proposed plan for Federal participation. | ITA | (a) Upon receipt of the statement, and the exhibits referred to in § 310.7, the Director shall prepare a proposed plan in cooperation with other interested departments and agencies of the Federal Government for Federal participation in the exposition. (b) In preparing the proposed plan for Federal participation in the exposition, the Director shall conduct a feasibility study of Federal participation including cost estimates by utilizing the services within the Federal Government, professional consultants and private sources as required and in accordance with applicable laws and regulations. (c) The Director, in the proposed plan for Federal participation in the exposition, shall determine whether or not a Federal pavilion should be constructed and, if so, whether or not the Government would have need for a permanent structure in the area of the exposition or whether a temporary structure would be more appropriate. (d) The Director shall seek the advice of the Administrator of the General Services Administration to the extent necessary in carrying out the proposed plan for Federal participation in the exposition. (e) Upon completion of the proposed plan for Federal participation in the exposition, the Director shall submit the plan to the Secretary. | ||||||
| 15:15:2.1.1.1.5.0.1.9 | 15 | Commerce and Foreign Trade | III | A | 310 | PART 310—OFFICIAL U.S. GOVERNMENT RECOGNITION OF AND PARTICIPATION IN INTERNATIONAL EXPOSITIONS HELD IN THE UNITED STATES | § 310.9 Report of the Secretary on Federal participation. | ITA | Upon receipt of the Director's proposed plan for Federal participation, the Secretary, within a reasonable time, shall submit a report to the President including: (a) Evidence that the exposition has met the criteria for Federal recognition and has been so recognized; (b) a statement that the exposition has been registered by the BIE; and (c) a proposed plan for the Federal participation referred to in § 310.8. | ||||||
| 21:21:5.0.1.1.2.1.1.1 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | A | Subpart A—General Provisions | § 310.3 Definitions and interpretations. | FDA | [39 FR 11680, Mar. 29, 1974, as amended at 39 FR 20484, June 11, 1974; 40 FR 31307, July 25, 1975; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985] | As used in this part: (a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392). (b) Department means the Department of Health and Human Services. (c) Secretary means the Secretary of Health and Human Services. (d) Commissioner means the Commissioner of Food and Drugs. (e) The term person includes individuals, partnerships, corporations, and associations. (f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part. (g) New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance. (h) The newness of a drug may arise by reason (among other reasons) of: (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for a drug use of a combination of two or more substances, none of which is a new drug. (3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug. (4) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body. (5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug. (i) [Reserved] (j) The term spo… | |||
| 21:21:5.0.1.1.2.1.1.2 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | A | Subpart A—General Provisions | § 310.4 Biologics; products subject to license control. | FDA | [64 FR 56448, Oct. 20, 1999, as amended at 70 FR 14981, Mar. 24, 2005] | (a) If a drug has an approved license under section 351 of the Public Health Service Act (42 U.S.C. 262 et seq. ) or under the animal virus, serum, and toxin law of March 4, 1913 (21 U.S.C. 151 et seq. ), it is not required to have an approved application under section 505 of the act. (b) To obtain marketing approval for radioactive biological products for human use, as defined in § 600.3(ee) of this chapter, manufacturers must comply with the provisions of § 601.2(a) of this chapter. | |||
| 21:21:5.0.1.1.2.1.1.3 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | A | Subpart A—General Provisions | § 310.6 Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products. | FDA | [39 FR 11680, Mar. 29, 1974, as amended at 48 FR 2755, Jan. 21, 1983; 50 FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990; 74 FR 13113, Mar. 26, 2009] | (a) The Food and Drug Administration's conclusions on the effectiveness of drugs are currently being published in the Federal Register as Drug Efficacy Study Implementation (DESI) Notices and as Notices of Opportunity for Hearing. The specific products listed in these notices include only those that were introduced into the market through the new drug procedures from 1938-62 and were submitted for review by the National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products which are identical to, related to, or similar to the products listed in these notices have been marketed under different names or by different firms during this same period or since 1962 without going through the new drug procedures or the Academy review. Even though these products are not listed in the notices, they are covered by the new drug applications reviewed and thus are subject to these notices. All persons with an interest in a product that is identical, related, or similar to a drug listed in a drug efficacy notice or a notice of opportunity for a hearing will be given the same opportunity as the applicant to submit data and information, to request a hearing, and to participate in any hearing. It is not feasible for the Food and Drug Administration to list all products which are covered by an NDA and thus subject to each notice. However, it is essential that the findings and conclusions that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective be applied to all identical, related, and similar drug products to which they are reasonably applicable. Any product not in compliance with an applicable drug efficacy notice is in violation of section 505 (new drugs) and/or section 502 (misbranding) of the act. (b)(1) An identical, related, or similar drug includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety as well as of any drug moiety related in chemical structure or known pharmacological proper… | |||
| 21:21:5.0.1.1.2.2.1.1 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | B | Subpart B—Specific Administrative Rulings and Decisions | § 310.100 New drug status opinions; statement of policy. | FDA | [39 FR 11680, Mar. 29, 1974] | (a) Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters that did not explicitly relate all of the necessary conditions and qualifications such as the quantitative formula for the drug and the conditions under which it was prescribed, recommended, or suggested. This has contributed to misunderstanding and misinterpretation of such opinions. (b) These informal opinions that an article is “not a new drug” or “no longer a new drug” require reexamination under the Kefauver-Harris Act (Public Law 87-781; 76 Stat. 788-89). In particular, when approval of a new drug application is withdrawn under provisions of section 505(e) of the Federal Food, Drug, and Cosmetic Act, a drug generally recognized as safe may become a “new drug” within the meaning of section 201(p) of said act as amended by the Kefauver-Harris Act on October 10, 1962. This is of special importance by reason of proposed actions to withdraw approval of new drug applications for lack of substantial evidence of effectiveness as a result of reports of the National Academy of Sciences—National Research Council on its review of drug effectiveness; for example, see the notice published in the Federal Register of January 23, 1968 (33 FR 818), regarding rutin, quercetin, et al. (c) Any marketed drug is a “new drug” if any labeling change made after October 9, 1962, recommends or suggests new conditions of use under which the drug is not generally recognized as safe and effective by qualified experts. Undisclosed or unreported side effects as well as the emergence of new knowledge presenting questions with respect to the safety or effectiveness of a drug may result in its becoming a “new drug” even though it was previously considered “not a new drug.” Any previously given informal advice that an article is “not a new drug” does … | |||
| 21:21:5.0.1.1.2.2.1.2 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | B | Subpart B—Specific Administrative Rulings and Decisions | § 310.103 New drug substances intended for hypersensitivity testing. | FDA | [39 FR 11680, Mar. 29, 1974, as amended at 55 FR 11578, Mar. 29, 1990; 67 FR 4907, Feb. 1, 2002] | (a) The Food and Drug Administration is aware of the need in the practice of medicine for the ingredients of a new drug to be available for tests of hypersensitivity to such ingredients and therefore will not object to the shipment of a new drug substance, as defined in § 310.3(g), for such purpose if all of the following conditions are met: (1) The shipment is made as a result of a specific request made to the manufacturer or distributor by a practitioner licensed by law to administer such drugs, and the use of such drugs for patch testing is not promoted by the manufacturer or distributor. (2) The new drug substance requested is an ingredient in a marketed new drug and is not one that is an ingredient solely in a new drug that is legally available only under the investigational drug provisions of this part. (3) The label bears the following prominently placed statements in lieu of adequate directions for use and in addition to complying with the other labeling provisions of the act: (i) “Rx only”; and (ii) “For use only in patch testing”. (4) The quantity shipped is limited to an amount reasonable for the purpose of patch testing in the normal course of the practice of medicine and is used solely for such patch testing. (5) The new drug substance is manufactured by the same procedures and meets the same specifications as the component used in the finished dosage form. (6) The manufacturer or distributor maintains records of all shipments for this purpose for a period of 2 years after shipment and will make them available to the Food and Drug Administration on request. (b) When the requested new drug substance is intended for investigational use in humans or the substance is legally available only under the investigational drug provisions of part 312 of this chapter, the submission of an “Investigational New Drug Application” (IND) is required. The Food and Drug Administration will offer assistance to any practitioner wishing to submit an Investigational New Drug Application. (c) This section does not … | |||
| 21:21:5.0.1.1.2.3.1.1 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | C | Subpart C—New Drugs Exempted From Prescription-Dispensing Requirements | § 310.200 Prescription-exemption procedure. | FDA | [39 FR 11680, Mar. 29, 1974, as amended at 41 FR 32582, Aug. 4, 1976; 42 FR 4714, Jan. 25, 1977; 42 FR 15674, Mar. 22, 1977; 72 FR 15043, Mar. 30, 2007] | (a) Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(B) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section. (b) Prescription-exemption procedure for drugs limited by a new drug application. Any drug limited to prescription use under section 503(b)(1)(B) of the act shall be exempted from prescription-dispensing requirements when the Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling. A proposal to exempt a drug from the prescription-dispensing requirements of section 503(b)(1)(B) of the act may be initiated by the Commissioner or by any interested person. Any interested person may file a petition seeking such exemption, which petition may be pursuant to part 10 of this chapter, or in the form of a supplement to an approved new drug application. (c) New drug status of drugs exempted from the prescription requirement. A drug exempted from the prescription requirement under the provisions of paragraph (b) of this section is a “new drug” within the meaning of section 201(p) of the act until it has been used to a material extent and for a material time under such conditions except as provided in paragraph (e) of this section. (d) Prescription legend not allowed on exempted drugs. The use of the prescription caution statement quoted in section 503(b) (4) of the act, in the labeling of a drug exempted under the provisions of this section, constitutes misbranding. Any other statement or suggestion in the labeling of a drug exempted under this section, that such drug is limited to prescription use, may constitute misbranding. (e) Prescription-exemption procedure of OTC drug review. A drug limited to prescription… | |||
| 21:21:5.0.1.1.2.3.1.2 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | C | Subpart C—New Drugs Exempted From Prescription-Dispensing Requirements | § 310.201 Exemption for certain drugs limited by new-drug applications to prescription sale. | FDA | [39 FR 11680, Mar. 29, 1974, as amended at 42 FR 36994, July 19, 1977; 52 FR 15892, Apr. 30, 1987; 52 FR 30055, Aug. 12, 1987; 55 FR 31779, Aug. 3, 1990; 57 FR 58374, Dec. 9, 1992; 58 FR 49898, Sept. 23, 1993; 59 FR 4218, Jan. 28, 1994; 60 FR 52507, Oct. 6, 1995; 72 FR 15043, Mar. 30, 2007; 72 FR 67640, Nov. 30, 2007] | (a) The prescription-dispensing requirements of section503(b)(1)(B) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to the following drugs subject to new drug applications: (1) N -Acetyl- p -aminophenol (acetaminophen, p -hydroxy-acetanilid) preparations meeting all the following conditions: (i) The N -acetyl- p -aminophenol is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act. (ii) The N -acetyl- p -aminophenol and all other components of the preparation meet their professed standards of identity, strength, quality, and purity. (iii) If the preparation is a new drug, an application pursuant to section 505 (b) of the act is approved for it. (iv) The preparation contains not more than 0.325 gram (5 grains) of N -acetyl- p -aminophenol per dosage unit, or if it is in liquid form not more than 100 milligrams of N -acetyl- p -aminophenol per milliliter. (v) The preparation is labeled with adequate directions for use in minor conditions as a simple analgesic. (vi) The dosages of N -acetyl- p -aminophenol recommended or suggested in the labeling do not exceed: For adults, 0.65 gram (10 grains) per dose or 2.6 grams (40 grains) per 24-hour period: for children 6 to 12 years of age, one-half of the maximum adult dose or dosage; for children 3 to 6 years of age, one-fifth of the maximum adult dose or dosage. (vii) The labeling bears, in juxtaposition with the dosage recommendations, a clear warning statement against administration of the drug to children under 3 years of age and against use of the drug for more than 10 days, unless such uses are directed by a physician. (viii) If the article is offered for use in arthritis or rheumatism, the labeling prominently bears a statement that the beneficial effects claimed are limited to the temporary relief of minor aches and pains o… | |||
| 21:21:5.0.1.1.2.4.1.1 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | D | Subpart D—Records and Reports | § 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. | FDA | [51 FR 24479, July 3, 1986, as amended at 52 FR 37936, Oct. 13, 1987; 55 FR 11578, Mar. 29, 1990; 57 FR 17980, Apr. 28, 1992; 62 FR 34167, June 25, 1997; 62 FR 52249, Oct. 7, 1997; 67 FR 9585, Mar. 4, 2002; 74 FR 13113, Mar. 26, 2009; 79 FR 33087, June 10, 2014] | (a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products. Any person subject to the reporting requirements of paragraph (c) of this section must also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA. (b) Definitions. The following definitions of terms apply to this section: Adverse drug experience. Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. Disability. A substantial disruption of a person's ability to conduct normal life functions. Individual case safety report (ICSR). A description of an adverse drug experience related to an individual patient or subject. ICSR attachments. Documents related to the adverse drug experience described in an ICSR, such as medical records, hospital discharge summaries, or other documentation. Life-threatening adverse drug experience. Any adverse drug experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse drug experience as it occurred, i.e. , it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death. Serious adverse drug experience. Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, … | |||
| 21:21:5.0.1.1.2.4.1.2 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | D | Subpart D—Records and Reports | § 310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications. | FDA | [80 FR 38938, July 8, 2015] | (a) Applicability. Marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application are subject to this section. (b) Notification of a permanent discontinuance or an interruption in manufacturing. The manufacturer of each product subject to this section must make the notifications required under § 314.81(b)(3)(iii) of this chapter and otherwise comply with § 314.81(b)(3)(iii) of this chapter. If the manufacturer of a product subject to this section fails to provide notification as required under § 314.81(b)(3)(iii), FDA will send a letter to the manufacturer and otherwise follow the procedures set forth under § 314.81(b)(3)(iii)( e ). (c) Drug shortages list. FDA will include on the drug shortages list required by § 314.81(b)(3)(iii)( d ) drug products that are subject to this section that it determines to be in shortage. For such drug products, FDA will provide the names of each manufacturer rather than the names of each applicant. With respect to information collected under this paragraph, FDA will observe the confidentiality and disclosure provisions set forth in § 314.81(b)(3)(iii)( d )( 2 ). | |||
| 21:21:5.0.1.1.2.5.1.1 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.501 Patient package inserts for oral contraceptives. | FDA | [54 FR 22587, May 25, 1989, as amended at 74 FR 13113, Mar. 26, 2009] | (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act. Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient (or to an agent of the patient) to whom the product is dispensed, except that the dispenser may provide the insert to the parent or legal guardian of a legally incompetent patient (or to the agent of either). The patient package insert is required to be placed in or accompany each package dispensed to the patient. (b) Distribution requirements. (1) For oral contraceptive drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be dispensed to a patient. (2) Patient package inserts for oral contraceptives dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first oral contraceptive and every 30 days thereafter, as long as the therapy continues. (c) Contents of patient package insert. A patient package insert for an oral contraceptive drug product is required to contain the following: (1) The name of the drug. (2) A summary including a statement concerning the effectiveness of oral contraceptives in preventing pregnancy, the contraindications to the drug's use, and a statement of the risks and benefits associated with the drug's use. (3) A statement comparing the effectiveness of oral contraceptives to other methods of contraception. (4) A boxed warning concerning the increased risks associated with cigarette smoking and oral contraceptive use. (5) A discussion of the cont… | |||
| 21:21:5.0.1.1.2.5.1.10 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac. | FDA | [54 FR 28786, July 7, 1989] | (a) Any product that bears labeling claims that it will arouse or increase sexual desire, or that it will improve sexual performance, is an aphrodisiac drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, sarsaparilla, strychnine, testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are powerful hormones when administered internally and are not safe for use except under the supervision of a physician. There is a lack of adequate data to establish general recognition of the safety and effectiveness of any of these ingredients, or any other ingredient, for OTC use as an aphrodisiac. Labeling claims for aphrodisiacs for OTC use are either false, misleading, or unsupported by scientific data. The following claims are examples of some that have been made for aphrodisiac drug products for OTC use: “acts as an aphrodisiac;” “arouses or increases sexual desire and improves sexual performance;” “helps restore sexual vigor, potency, and performance;” “improves performance, staying power, and sexual potency;” and “builds virility and sexual potency.” Based on evidence currently available, any OTC drug product containing ingredients for use as an aphrodisiac cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or prompted for use as an aphrodisiac is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act, (the act), for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represen… | |||
| 21:21:5.0.1.1.2.5.1.11 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents. | FDA | [40 FR 25171, June 17, 1985, as amended at 55 FR 11579, Mar. 29, 1990] | (a) Thiamine hydrochloride (vitamin B-1) has been marketed as an ingredient in over-the-counter (OTC) drug products for oral use as an insect repellent (an orally administered drug product intended to keep insects away). There is a lack of adequate data to establish the effectiveness of this, or any other ingredient for OTC oral use as an insect repellent. Labeling claims for OTC orally administered insect repellent drug products are either false, misleading, or unsupported by scientific data. The following claims are examples of some that have been made for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos avoid you,” “bugs stay away,” “keep mosquitos away for 12 to 24 hours,” and “the newest way to fight mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted for oral use as an insect repellent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug and Cosmetic Act for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted OTC for oral use as an insect repellent is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) Any such drug product in interstate commerce after December 17, 1985, that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.12 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. | FDA | [58 FR 47610, Sept. 9, 1993] | (a) The term “hormone” is used broadly to describe a chemical substance formed in some organ of the body, such as the adrenal glands or the pituitary, and carried to another organ or tissue, where it has a specific effect. Hormones include, for example, estrogens, progestins, androgens, anabolic steroids, and adrenal corticosteroids, and synthetic analogs. Estrogens, progesterone, pregnenolone, and pregnenolone acetate have been present as ingredients in OTC drug products marketed for topical use as hormone creams. However, there is a lack of adequate data to establish effectiveness for any OTC drug use of these ingredients. Therefore, with the exception of those hormones identified in paragraph (e) of this section, any OTC drug product containing an ingredient offered for use as a topically applied hormone cannot be considered generally recognized as safe and effective for its intended use. The intended use of the product may be inferred from the product's labeling, promotional material, advertising, and any other relevant factor. The use of the word “hormone” in the text of the labeling or in the ingredient statement is an implied drug claim. The claim implied by the use of this term is that the product will have a therapeutic or some other physiological effect on the body. Therefore, reference to a product as a “hormone cream” or any statement in the labeling indicating that “hormones” are present in the product, or any statement that features or emphasizes the presence of a hormone ingredient in the product, will be considered to be a therapeutic claim for the product, or a claim that the product will affect the structure or function of the body, and will consequently cause the product to be a drug. (b) Any OTC drug product that is labeled, represented, or promoted as a topically applied hormone-containing product for drug use, with the exception of those hormones identified in paragraph (e) of this section, is regarded as a new drug within the meaning of section 201(p) of the act, for which an approved appl… | |||
| 21:21:5.0.1.1.2.5.1.13 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils. | FDA | [58 FR 60336, Nov. 15, 1993] | (a) Aminacrine hydrochloride, benzocaine, bismuth subnitrate, calomel, camphor, cholesterol, ergot fluid extract, hexachlorophene, ichthammol, isobutamben, juniper tar (oil of cade), lanolin, magnesium sulfate, menthol, methyl salicylate, oxyguinoline sulfate, petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide have been present in OTC boil treatment drug products. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ingredient for OTC use for the treatment of boils. Treatment is defined as reducing the size of a boil or reducing an infection related to a boil. Treatment has involved the use of “drawing salves” for these purposes. These “drawing salves” contained various ingredients. Based on evidence currently available, any OTC drug product offered for the treatment of boils cannot be considered generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted for the treatment of boils is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any OTC boil treatment drug product is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After May 7, 1991, any such OTC drug product that contains aminacrine hydrochloride, bismuth subnitrate, calomel, camphor, cholesterol, ergot fluid extract, hexachlorophene, isobutamben, juniper tar (oil of cade), lanolin, magnesium sulfate, menthol, methyl salicylate, oxyguino… | |||
| 21:21:5.0.1.1.2.5.1.14 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. | FDA | [55 FR 6930, Feb. 27, 1990] | (a) The amino acids glycine, alanine, and glutamic acid (alone or in combination) and the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the symptoms of benign prostatic hypertrophy, e.g., urinary urgency and frequency, excessive urinating at night, and delayed urination. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ingredients for OTC use in relieving the symptoms of benign prostatic hypertrophy. In addition, there is no definitive evidence that any drug product offered for the relief of the symptoms of benign prostatic hypertrophy would alter the obstructive or inflammatory signs and symptoms of this condition. Therefore, self-medication with OTC drug products might unnecessarily delay diagnosis and treatment of progressive obstruction and secondary infections. Based on evidence currently available, any OTC drug product containing ingredients offered for use in relieving the symptoms of benign prostatic hypertrophy cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic hypertrophy is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use to relieve the symptoms of benign prostatic hypertrophy is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After August 27, 1990, any such OTC drug product initially introduced or initially delivered for introduction into … | |||
| 21:21:5.0.1.1.2.5.1.15 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.533 Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. | FDA | [50 FR 46587, Nov. 8, 1985, as amended at 55 FR 11579, Mar. 29, 1990] | (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug products for use as an anticholinergic. Anticholinergic drugs have been marketed OTC in cough-cold drug products to relieve excessive secretions of the nose and eyes, symptoms that are commonly associated with hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic is probably safe at dosages that have been used in marketed cough-cold products (0.2 to 0.3 milligram); however, there are inadequate data to establish general recognition of the effectiveness of this ingredient. The belladonna alkaloids, which contain atropine ( d, dl hyoscyamine) and scopolamine ( l- hyoscine), are probably safe for oral use at dosages that have been used in marketed cough-cold products (0.2 milligram) but there are inadequate data to establish general recognition of the effectiveness of these ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained in Atropa belladonna and Datura stramonium, are neither safe nor effective as an OTC anticholinergic. There are inadequate safety and effectiveness data to establish general recognition of the safety and/or effectiveness or any of these ingredients, or any other ingredient, for OTC use as an anticholinergic in cough-cold drug products. (b) Any OTC cough-cold drug product that is labeled, represented, or promoted for use as an anticholinergic is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act, for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any cough-cold drug product labeled, represented, or promoted for OTC u… | |||
| 21:21:5.0.1.1.2.5.1.16 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. | FDA | [51 FR 26114, July 18, 1986, as amended at 55 FR 11579, Mar. 29, 1990] | (a) Allantoin, carbamide peroxide in anhydrous glycerin, water soluble chlorophyllins, and hydrogen peroxide in aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing agents. Oral wound healing agents have been marketed as aids in the healing of minor oral wounds by means other than cleansing and irrigating, or by serving as a protectant. Allantoin, carbamide peroxide in anhydrous glycerin, water soluble chlorophyllins, and hydrogen peroxide in aqueous solution are safe for use as oral wound healing agents, but there are inadequate data to establish general recognition of the effectiveness of these ingredients as oral wound healing agents. (b) Any OTC drug product that is labeled, represented, or promoted for use as an oral wound healing agent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act, for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use as an oral wound healing agent is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After the effective date of the final regulation, any OTC drug product that is labeled, represented, or promoted for use as an oral wound healing agent may not be initially introduced or initially delivered for introduction into interstate commerce unless it is the subject of an approved new drug application. | |||
| 21:21:5.0.1.1.2.5.1.17 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent. | FDA | [58 FR 46754, Sept. 2, 1993] | (a) Denatonium benzoate and sucrose octaacetate have been present in OTC nailbiting and thumbsucking deterrent drug products. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these and any other ingredients (e.g., cayenne pepper) for OTC use as a nailbiting or thumbsucking deterrent. Based on evidence currently available, any OTC drug product containing ingredients offered for use as a nailbiting or thumbsucking deterrent cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, and promoted as a nailbiting or thumbsucking deterrent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use as a nailbiting or thumbsucking deterrent is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After March 2, 1994, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.18 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.537 Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores. | FDA | [57 FR 29173, June 30, 1992] | (a) l -lysine (lysine, lysine hydrochloride), Lactobacillus acidophilus, and Lactobacillus bulgaricus have been present in orally administered OTC drug products to treat fever blisters and cold sores. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other orally administered ingredients for OTC use to treat or relieve the symptoms or discomfort of fever blisters and cold sores. Based on evidence currently available, any OTC drug product for oral administration containing ingredients offered for use in treating or relieving the symptoms or discomfort of fever blisters and cold sores cannot be generally recognized as safe and effective. (b) Any OTC drug product for oral administration that is labeled, represented, or promoted to treat or relieve the symptoms or discomfort of fever blisters and cold sores is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product for oral administration labeled, represented, or promoted for OTC use to treat or relieve the symptoms or discomfort of fever blisters and cold sores is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After December 30, 1992, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.19 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief. | FDA | [58 FR 47605, Sept. 9, 1993, as amended at 68 FR 24348, May 7, 2003] | (a) Any product that bears labeling claims such as for “temporary relief of discomfort from ingrown toenails,” or “ingrown toenail relief product,” or “ingrown toenail reliever,” or similar claims is considered an ingrown toenail relief drug product. Benzocaine, chlorobutanol, chloroxylenol, dibucaine, tannic acid, and urea have been present as ingredients in such products. There is lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ingredients for OTC use for ingrown toenail relief. Based on evidence currently available, any OTC drug product containing ingredients offered for use for ingrown toenail relief cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted for ingrown toenail relief is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use for ingrown toenail relief is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After March 9, 1994, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. (e) This section does not apply to sodium sulfide labeled, represented, or promoted for OTC topical use for ingrown toenail relief in accordance with part 358, subpart D of this chapter, after June 6, 2003. | |||
| 21:21:5.0.1.1.2.5.1.2 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.502 Certain drugs accorded new drug status through rulemaking procedures. | FDA | [62 FR 12084, Mar. 14, 1997, as amended at 64 FR 401, Jan. 5, 1999; 84 FR 68334, Dec. 16, 2019] | (a) The drugs listed in this paragraph (a) have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 of this chapter is required for marketing the following drugs: (1) Aerosol drug products for human use containing 1,1,1-trichloroethane. (2) Aerosol drug products containing zirconium. (3) Amphetamines (amphetamine, dextroamphetamine, and their salts, and levamfetamine and its salts) for human use. (4) Camphorated oil drug products. (5) Certain halogenated salicylanilides (tribromsalan (TBS, 3,4′,5-tribromosalicylanilide), dibromsalan (DBS, 4′, 5-dibromosalicylanilide), metabromsalan (MBS, 3, 5-dibromosalicylanilide), and 3,3′, 4,5′-tetrachlorosalicylanilide (TC-SA)) as an ingredient in drug products. (6) Chloroform used as an ingredient (active or inactive) in drug products. (7) Cobalt preparations intended for use by man. (8) Intrauterine devices for human use for the purpose of contraception that incorporate heavy metals, drugs, or other active substances. (9) Oral prenatal drugs containing fluorides intended for human use. (10) Parenteral drug products in plastic containers. (11) [Reserved] (12) Sweet spirits of nitre drug products. (13) Thorium dioxide for drug use. (14) Timed release dosage forms. (15) Vinyl chloride as an ingredient, including propellant, in aerosol drug products. (b) [Reserved] | |||
| 21:21:5.0.1.1.2.5.1.20 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers. | FDA | [53 FR 31271, Aug. 17, 1988] | (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to establish the effectiveness of these or any other ingredients for use in treating achlorhydria and hypochlorhydria, and because such conditions are asymptomatic, any OTC drug product containing ingredients offered for use as a stomach acidifier cannot be considered generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted for use as a stomach acidifier is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act, for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted as a stomach acidifier for OTC use is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After the effective date of the final regulation, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.21 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia. | FDA | [55 FR 19858, May 11, 1990] | (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This condition is not amenable to self-diagnosis or self-treatment. Treatment of this condition should be restricted to the supervision of a physician. For this reason, any drug product containing ingredients offered for OTC use in the treatment of hypophosphatemia cannot be considered generally recognized as safe and effective. (b) Any drug product that is labeled, represented, or promoted for OTC use in the treatment of hypophosphatemia is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use in the treatment of hypophosphatemia is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of his chapter. (d) After November 12, 1990, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.22 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia. | FDA | [55 FR 19858, May 11, 1990] | (a) Hyperphosphatemia is a condition in which an abnormally high plasma level of phosphate occurs in the blood. This condition in not amenable to self-diagnosis or self-treatment. Treatment of this condition should be restricted to the supervision of a physician. For this reason, any drug product containing ingredients offered for OTC use in the treatment of hyperphosphatemia cannot be considered generally recognized as safe and effective. (b) Any drug product that is labeled, represented, or promoted for OTC use in the treatment of hyperphosphatemia is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for use in the treatment of hyperphosphatemia is safe and effective for the purpose intended must comply with the requirements and procedures governing use of investigational new drugs set forth in part 312 of this chapter. (d) After November 12, 1990, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.23 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. | FDA | [60 FR 20165, Apr. 24, 1995] | (a) Hemicellulase, pancreatin, and pancrelipase have been present as ingredients in exocrine pancreatic insufficiency drug products. Pancreatin and pancrelipase are composed of enzymes: amylase, trypsin (protease), and lipase. Significant differences have been shown in the bioavailability of marketed exocrine pancreatic insufficiency drug products produced by different manufacturers. These differences raise a potential for serious risk to patients using these drug products. The bioavailability of pancreatic enzymes is dependent on the process used to manufacture the drug products. Information on this process is not included in an OTC drug monograph. Therefore, the safe and effective use of these enzymes for treating exocrine pancreatic insufficiency cannot be regulated adequately by an OTC drug monograph. Information on the product's formulation, manufacture, quality control procedures, and final formulation effectiveness testing are necessary in an approved application to ensure that a company has the ability to manufacture a proper bioactive formulation. In addition, continuous physician monitoring of patients who take these drug products is a collateral measure necessary to the safe and effective use of these enzymes, causing such products to be available by prescription only. (b) Any drug product that is labeled, represented, or promoted for OTC use in the treatment of exocrine pancreatic insufficiency is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use in the treatment of exocrine pancreatic insufficiency is safe and effective for the purpose intended must comply with the requirements and procedures … | |||
| 21:21:5.0.1.1.2.5.1.24 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent. | FDA | [58 FR 31241, June 1, 1993] | (a) Any product that bears labeling claims that it “helps stop or reduce the cigarette urge,” “helps break the cigarette habit,” “helps stop or reduce smoking,” or similar claims is a smoking deterrent drug product. Cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, lobeline (in the form of lobeline sulfate or natural lobelia alkaloids or Lobelia inflata herb), menthol, methyl salicylate, povidone-silver nitrate, quinine ascorbate, silver acetate, silver nitrate, and thymol have been present as ingredients in such drug products. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ingredients for OTC use as a smoking deterrent. Based on evidence currently available, any OTC drug product containing ingredients offered for use as a smoking deterrent cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted as a smoking deterrent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use as a smoking deterrent is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After May 7, 1991, any such OTC drug product containing cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, menthol, methyl salicylate, quinine ascorbate, silver nitrate, and/or thymol initially introduced or initially delivered… | |||
| 21:21:5.0.1.1.2.5.1.25 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. | FDA | [55 FR 46919, Nov. 7, 1990] | (a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: (1) Topical acne drug products. Alcloxa Alkyl isoquinolinium bromide Aluminum chlorohydrex Aluminum hydroxide Benzocaine Benzoic acid Boric acid Calcium polysulfide Calcium thiosulfate Camphor Chloroxylenol Cloxyquin Coal tar Dibenzothiophene Estrone Magnesium aluminum silicate Magnesium sulfate Phenol Phenolate sodium Phenyl salicylate Povidone-iodine Pyrilamine maleate Resorcinol (as single ingredient) Resorcinol monoacetate (as single ingredient) Salicylic acid (over 2 up to 5 percent) Sodium borate Sodium thiosulfate Tetracaine hydrochloride Thymol Vitamin E Zinc oxide Zinc stearate Zinc sulfide Alcloxa Alkyl isoquinolinium bromide Aluminum chlorohydrex Aluminum hydroxide Benzocaine Benzoic acid Boric acid Calcium polysulfide Calcium thiosulfate Camphor Chloroxylenol Cloxyquin Coal tar Dibenzothiophene Estrone Magnesium aluminum silicate Magnesium sulfate Phenol Phenolate sodium Phenyl salicylate Povidone-iodine Pyrilamine maleate Resorcinol (as single ingredient) Resorcinol monoacetate (as single ingredient) Salicylic acid (over 2 up to 5 percent) Sodium borate Sodium thiosulfate Tetracaine hydrochloride Thymol Vitamin E Zinc oxide Zinc stearate Zinc sulfide (2) Anticaries drug products —(i) Approved as of May 7, 1991. Hydrogen fluoride Sodium carbonate Sodium monofluorophosphate (6 percent rinse) Sodium phosphate Hydrogen fluoride Sodium carbonate Sodium monofluorophosphate (6 percent rinse) Sodium phosphate (ii) Approved as of October 7, 1996. Calcium sucrose phosphate Dicalcium phosphate dihydrate Disodium hydrogen phosphate 1 1 These ingredients… | |||
| 21:21:5.0.1.1.2.5.1.26 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. | FDA | [59 FR 43252, Aug. 22, 1994] | (a) Quinine sulfate alone or in combination with vitamin E has been present in over-the-counter (OTC) drug products for the treatment and/or prevention of nocturnal leg muscle cramps, i.e. , a condition of localized pain in the lower extremities usually occurring in middle life and beyond with no regular pattern concerning time or severity. There is a lack of adequate data to establish general recognition of the safety and effectiveness of quinine sulfate, vitamin E, or any other ingredients for OTC use in the treatment and/or prevention of nocturnal leg muscle cramps. In the doses used to treat or prevent this condition, quinine sulfate has caused adverse events such as transient visual and auditory disturbances, dizziness, fever, nausea, vomiting, and diarrhea. Quinine sulfate may cause unpredictable serious and life-threatening hypersensitivity reactions requiring medical intervention and hospitalization; fatalities have been reported. The risk associated with use of quinine sulfate, in the absence of evidence of its effectiveness, outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition. Based upon the adverse benefit-to-risk ratio, any drug product containing quinine or quinine sulfate cannot be considered generally recognized as safe for the treatment and/or prevention of nocturnal leg muscle cramps. (b) Any OTC drug product that is labeled, represented, or promoted for the treatment and/or prevention of nocturnal leg muscle cramps is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use for… | |||
| 21:21:5.0.1.1.2.5.1.27 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria. | FDA | [63 FR 13528, Mar. 20, 1998] | (a) Quinine and quinine salts have been used OTC for the treatment and/or prevention of malaria, a serious and potentially life-threatening disease. Quinine is no longer the drug of choice for the treatment and/or prevention of most types of malaria. In addition, there are serious and complicating aspects of the disease itself and some potentially serious and life-threatening risks associated with the use of quinine at doses employed for the treatment of malaria. There is a lack of adequate data to establish general recognition of the safety of quinine drug products for OTC use in the treatment and/or prevention of malaria. Therefore, quinine or quinine salts cannot be safely and effectively used for the treatment and/or prevention of malaria except under the care and supervision of a doctor. (b) Any OTC drug product containing quinine or quinine salts that is labeled, represented, or promoted for the treatment and/or prevention of malaria is regarded as a new drug within the meaning of section 201(p) of the act, for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use for the treatment and/or prevention of malaria is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After April 20, 1998, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.28 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. | FDA | [64 FR 44658, Aug. 17, 1999] | (a) Colloidal silver ingredients and silver salts have been marketed in over-the-counter (OTC) drug products for the treatment and prevention of numerous disease conditions. There are serious and complicating aspects to many of the diseases these silver ingredients purport to treat or prevent. Further, there is a lack of adequate data to establish general recognition of the safety and effectiveness of colloidal silver ingredients or silver salts for OTC use in the treatment or prevention of any disease. These ingredients and salts include, but are not limited to, silver proteins, mild silver protein, strong silver protein, silver, silver ion, silver chloride, silver cyanide, silver iodide, silver oxide, and silver phosphate. (b) Any OTC drug product containing colloidal silver ingredients or silver salts that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product containing colloidal silver or silver salts labeled, represented, or promoted for any OTC drug use is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs as set forth in part 312 of this chapter. (d) After September 16, 1999, any such OTC drug product containing colloidal silver or silver salts initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.3 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.503 Requirements regarding certain radioactive drugs. | FDA | [39 FR 11680, Mar. 29, 1974, as amended at 40 FR 31307, July 25, 1975; 40 FR 44543, Sept. 29, 1975; 41 FR 35171, Aug. 20, 1976; 41 FR 42947, Sept. 29, 1976; 50 FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990; 64 FR 56449, Oct. 20, 1999; 80 FR 18091, Apr. 3, 2015] | (a) On January 8, 1963 (28 FR 183), the Commissioner of Food and Drugs exempted investigational radioactive new drugs from part 312 of this chapter provided they were shipped in complete conformity with the regulations issued by the Nuclear Regulatory Commission. This exemption also applied to investigational radioactive biologics. (b) It is the opinion of the Nuclear Regulatory Commission, and the Food and Drug Administration that this exemption should not apply for certain specific drugs and that these drugs should be appropriately labeled for uses for which safety and effectiveness can be demonstrated by new drug applications or through licensing under the Public Health Service Act (42 U.S.C. 262 et seq. ) in the case of biologics. Continued distribution under the investigational exemption when the drugs are intended for established uses will not be permitted. (c) Based on its experience in regulating investigational radioactive pharmaceuticals, the Nuclear Regulatory Commission has compiled a list of reactor-produced isotopes for which it considers that applicants may reasonably be expected to submit adequate evidence of safety and effectiveness for use as recommended in appropriate labeling. Such use may include, among others, the uses in this tabulation: 1 This item has been removed from the AEC list for kidney scans but is included as the requirements of this order are applicable. (d)(1) In view of the extent of experience with the isotopes listed in paragraph (c) of this section, the Nuclear Regulatory Commission and the Food and Drug Administration conclude that such isotopes should not be distributed under investigational-use labeling when they are actually intended for use in medical practice. (2) The exemption referred to in paragraph (a) of this section, as applied to any drug or biologic containing any of the isotopes listed in paragraph (c) of this section, in the “chemical form” and intended for the uses stated, is terminated on March 3, 1972, except as provided in paragraph (d)(3) of this … | |||
| 21:21:5.0.1.1.2.5.1.4 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.509 Parenteral drug products in plastic containers. | FDA | [62 FR 12084, Mar. 14, 1997] | (a) Any parenteral drug product packaged in a plastic immediate container is not generally recognized as safe and effective, is a new drug within the meaning of section 201(p) of the act, and requires an approved new drug application as a condition for marketing. An “Investigational New Drug Application” set forth in part 312 of this chapter is required for clinical investigations designed to obtain evidence of safety and effectiveness. (b) As used in this section, the term “large volume parenteral drug product” means a terminally sterilized aqueous drug product packaged in a single-dose container with a capacity of 100 milliliters or more and intended to be administered or used intravenously in a human. (c) Until the results of compatibility studies are evaluated, a large volume parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or after April 16, 1979, is misbranded unless its labeling contains a warning that includes the following information: (1) A statement that additives may be incompatible. (2) A statement that, if additive drugs are introduced into the parenteral system, aseptic techniques should be used and the solution should be thoroughly mixed. (3) A statement that a solution containing an additive drug should not be stored. (d) This section does not apply to a biological product licensed under the Public Health Service Act of July 1, 1944 (42 U.S.C. 201). | |||
| 21:21:5.0.1.1.2.5.1.5 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.515 Patient package inserts for estrogens. | FDA | [55 FR 18723, May 4, 1990, as amended at 74 FR 13113, Mar. 26, 2009] | (a) Requirement for a patient package insert. FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs. Accordingly, except as provided in paragraph (e) of this section, each estrogen drug product restricted to prescription distribution, including products containing estrogens in fixed combinations with other drugs, shall be dispensed to patients with a patient package insert containing information concerning the drug's benefits and risks. An estrogen drug product that does not comply with the requirements of this section is misbranded under section 502(a) of the Federal Food, Drug, and Cosmetic Act. (b) Distribution requirements. (1) For estrogen drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be dispensed to a patient. (2) In the case of estrogen drug products in bulk packages intended for multiple dispensing, and in the case of injectables in multiple-dose vials, a sufficient number of patient labeling pieces shall be included in or with each package to assure that one piece can be included with each package or dose dispensed or administered to every patient. Each bulk package shall be labeled with instructions to the dispensor to include one patient labeling piece with each package dispensed or, in the case of injectables, with each dose administered to the patient. This section does not preclude the manufacturer or labeler from distributing additional patient labeling pieces to the dispensor. (3) Patient package inserts for estrogens dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first estrogen and every 30 days thereafter, as long as the therapy continues. (c) Patient package insert contents. A patie… | |||
| 21:21:5.0.1.1.2.5.1.6 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class. | FDA | [49 FR 14331, Apr. 11, 1984] | (a) The University Group Diabetes Program clinical trial has reported an association between the administration of tolbutamide and increased cardiovascular mortality. The Food and Drug Administration has concluded that this reported association provides adequate basis for a warning in the labeling. In view of the similarities in chemical structure and mode of action, the Food and Drug Administration also believes it is prudent from a safety standpoint to consider that the possible increased risk of cardiovascular mortality from tolbutamide applies to all other sulfonylurea drugs as well. Therefore, the labeling for oral hypoglycemic drugs of the sulfonylurea class shall include a warning concerning the possible increased risk of cardiovascular mortality associated with such use, as set forth in paragraph (b) of this section. (b) Labeling for oral hypoglycemic drugs of the sulfonylurea class shall include in boldface type at the beginning of the “Warnings” section of the labeling the following statement: Special Warning on Increased Risk of Cardiovascular Mortality The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups ( Diabetes, 19 (supp. 2): 747-830, 1970). UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2 1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the inc… | |||
| 21:21:5.0.1.1.2.5.1.7 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.518 Drug products containing iron or iron salts. | FDA | [68 FR 59715, Oct. 17, 2003] | Drug products containing elemental iron or iron salts as an active ingredient in solid oral dosage form, e.g., tablets or capsules shall meet the following requirements: (a) Labeling. (1) The label of any drug in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts for use as an iron source shall bear the following statement: WARNING: Accidental overdose or iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. WARNING: Accidental overdose or iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. (2)(i) The warning statement required by paragraph (a)(1) of this section shall appear prominently and conspicuously on the information panel of the immediate container label. (ii) If a drug product is packaged in unit-dose packaging, and if the immediate container bears labeling but not a label, the warning statement required by paragraph (a)(1) of this section shall appear prominently and conspicuously on the immediate container labeling in a way that maximizes the likelihood that the warning is intact until all of the dosage units to which it applies are used. (3) Where the immediate container is not the retail package, the warning statement required by paragraph (a)(1) of this section shall also appear prominently and conspicuously on the information panel of the retail package label. (4) The warning statement shall appear on any labeling that contains warnings. (5) The warning statement required by paragraph (a)(1) of this section shall be set off in a box by use of hairlines. (b) The iron-containing inert tablets supplied in monthly packages of oral contraceptives are categorically exempt from the requirements of paragraph (a) of this section. | |||
| 21:21:5.0.1.1.2.5.1.8 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives. | FDA | [44 FR 36380, June 22, 1979; 45 FR 47422, July 15, 1980, as amended at 55 FR 11579, Mar. 29, 1990] | (a) Antihistamines, bromides, and scopolamine compounds, either singly or in combinations, have been marketed as ingredients in over-the-counter (OTC) drug products for use as daytime sedatives. The following claims have been made for daytime sedative products: “occasional simple nervous tension,” “nervous irritability,” “nervous tension headache,” “simple nervousness due to common every day overwork and fatigue,” “a relaxed feeling,” “calming down and relaxing,” “gently soothe away the tension,” “calmative,” “resolving that irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional stress . . . helps you work relaxed.” Based on evidence presently available, there are no ingredients that can be generally recognized as safe and effective for use as OTC daytime sedatives. (b) Any OTC drug product that is labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication) is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication) is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) Any OTC daytime sedative drug product introduced into interstate commerce after December 24, 1979, that is not in compliance with this section is subject to regulatory action. | |||
| 21:21:5.0.1.1.2.5.1.9 | 21 | Food and Drugs | I | D | 310 | PART 310—NEW DRUGS | E | Subpart E—Requirements for Specific New Drugs or Devices | § 310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. | FDA | [54 FR 28777, July 7, 1989] | (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and all other B-vitamins, dexpanthenol, estradiol and other topical hormones, jojoba oil, lanolin, nucleic acids, polysorbate 20, polysorbate 60, sulfanilamide, sulfur 1 percent on carbon in a fraction of paraffinic hydrocarbons, tetracaine hydrochloride, urea, and wheat germ oil have been marketed as ingredients in OTC drug products for external use as hair growers or for hair loss prevention. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ingredients intended for OTC external use as a hair grower or for hair loss prevention. Based on evidence currently available, all labeling claims for OTC hair grower and hair loss prevention drug products for external use are either false, misleading, or unsupported by scientific data. Therefore, any OTC drug product for external use containing an ingredient offered for use as a hair grower or for hair loss prevention cannot be considered generally recognized as safe and effective for its intended use. (b) Any OTC drug product that is labeled, represented, or promoted for external use as a hair grower or for hair loss prevention is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC external use as a hair grower or for hair loss prevention is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After January 8, 1990, any such OTC drug product initially introduced or initially delivered … | |||
| 24:24:2.1.2.5.2.0.221.1 | 24 | Housing and Urban Development | III | 310 | PART 310—BYLAWS OF THE GOVERNMENT NATIONAL MORTGAGE ASSOCIATION | § 310.1 Bylaws of the Association. | HUD | The bylaws of the Association shall be duly adopted by the Secretary of Housing and Urban Development pursuant to section 308 of the National Housing Act (12 U.S.C. 1723) and shall govern the performance of the powers and duties granted to or imposed upon the Association by law. | |||||||
| 40:40:30.0.1.1.7.1.5.1 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | A | Subpart A—General Information | § 310.1 What is the purpose of this part? | EPA | This part sets up procedures for EPA to reimburse local governments for certain emergency response costs. Local governments may receive up to $25,000 to help lighten financial burdens related to emergency response to hazardous substance releases. This reimbursement does NOT replace funding that local governments normally provide for emergency response. | ||||
| 40:40:30.0.1.1.7.1.5.2 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | A | Subpart A—General Information | § 310.2 What is the statutory authority for this part? | EPA | This part is authorized under section 123 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) (Pub. L. 96-510, 42 U.S.C. 9601-9675), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) (Pub. L. 99-499, 42 U.S.C. 9601). | ||||
| 40:40:30.0.1.1.7.1.5.3 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | A | Subpart A—General Information | § 310.3 What terms have specific definitions? | EPA | For purposes of this part except when otherwise specified: (a) Application means Form 9310-1, shown in appendix III of this part, including all documentation and additional information you submit to support a request for reimbursement. (b) Date of completion means the date when you have completed all field work and you have received all deliverables (such as lab results, technical expert reports, or invoices) due under a contract or other agreement. (c) Emergency Planning and Community Right-to-Know Act of 1986 means Title III—Emergency Planning and Community Right-to-Know Act of the Superfund Amendments and Reauthorization Act of 1986 (EPCRA) (Pub. L. 99-499, 42 U.S.C. 11000-11050). (d) Federally-recognized Indian Tribe, as defined by section 101(36) of CERCLA, means any Indian Tribe, band, nation, or other organized group or community, including any Alaska Native village but not including any Alaska Native regional or village corporation, which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians. (e) General purpose unit of local government means the governing body of a county, parish, municipality, city, town, township, Federally-recognized Indian tribe or similar governing body. This term does not include special purpose districts. (f) Hazardous substance. (1) Hazardous substance, as defined by section 101(14) of CERCLA, means: (i) Any substance designated pursuant to section 311(b)(2)(A) of the Federal Water Pollution Control Act (Pub. L. 101-380, 33 U.S.C. 1251 et seq. ); (ii) Any element, compound, mixture, solution, or substance designated pursuant to section 102 of CERCLA; (iii) Any hazardous waste having the characteristics identified under or listed pursuant to section 3001 of the Solid Waste Disposal Act (Pub. L. 89-272, 42 U.S.C. 3259 et seq. ) (but not including any waste the regulation of which under the Solid Waste Disposal Act has been suspended by Act of Congress); (iv) Any toxic pol… | ||||
| 40:40:30.0.1.1.7.1.5.4 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | A | Subpart A—General Information | § 310.4 What abbreviations should I know? | EPA | The following abbreviations appear in this part: CERCLA—The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Pub. L. 96-510, 42 U.S.C. 9601-9675), as amended by the Superfund Amendments and Reauthorization Act of 1986, also known as Superfund. EPA or the Agency—Environmental Protection Agency. EPCRA—Emergency Planning and Community Right-to-Know Act of 1986 (Pub. L. 99-499, 42 U.S.C. 11000-11050). LEPC—Local Emergency Planning Committee. NCP—National Oil and Hazardous Substances Pollution Contingency Plan also known as the National Contingency Plan (40 CFR part 300). NRC—National Response Center. OMB—Office of Management and Budget. PRP—Potentially Responsible Party. SARA—The Superfund Amendments and Reauthorization Act of 1986 (Pub. L. 99-499, 42 U.S.C. 9601). SERC—State Emergency Response Commission. USCG—U.S. Coast Guard. CERCLA—The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Pub. L. 96-510, 42 U.S.C. 9601-9675), as amended by the Superfund Amendments and Reauthorization Act of 1986, also known as Superfund. EPA or the Agency—Environmental Protection Agency. EPCRA—Emergency Planning and Community Right-to-Know Act of 1986 (Pub. L. 99-499, 42 U.S.C. 11000-11050). LEPC—Local Emergency Planning Committee. NCP—National Oil and Hazardous Substances Pollution Contingency Plan also known as the National Contingency Plan (40 CFR part 300). NRC—National Response Center. OMB—Office of Management and Budget. PRP—Potentially Responsible Party. SARA—The Superfund Amendments and Reauthorization Act of 1986 (Pub. L. 99-499, 42 U.S.C. 9601). SERC—State Emergency Response Commission. USCG—U.S. Coast Guard. | ||||
| 40:40:30.0.1.1.7.2.5.1 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.5 Am I eligible for reimbursement? | EPA | If you are the governing body of a county, parish, municipality, city, town, township, federally-recognized Indian tribe or general purpose unit of local government, you are eligible for reimbursement. This does not include special purpose districts. | ||||
| 40:40:30.0.1.1.7.2.5.2 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.6 Are states eligible? | EPA | States are NOT eligible for reimbursement under this part, and states may NOT request reimbursement on behalf of their local governments. | ||||
| 40:40:30.0.1.1.7.2.5.3 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.7 Can more than one local agency or government be reimbursed for response to the same incident? | EPA | No. EPA will accept only one reimbursement request for a single response. A single response includes all of the temporary emergency measures that ALL local governments or agencies conduct in response to a single hazardous substance release. If more than one local government or agency responds, you must decide among yourselves who will request reimbursement on behalf of all. | ||||
| 40:40:30.0.1.1.7.2.6.4 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.8 Can EPA reimburse the entire cost of my response? | EPA | Possibly not. EPA can only reimburse you for temporary emergency measures you take in response to releases of hazardous substances, pollutants, or contaminants. The statute allows reimbursement for only certain costs, and by statute, the total amount of the reimbursement may not exceed $25,000 for a single response. | ||||
| 40:40:30.0.1.1.7.2.6.5 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.9 If more than one local agency or government is involved, can each receive up to $25,000? | EPA | No. The maximum amount EPA can reimburse is $25,000 for a single response, which includes all activities by ALL local responders. If the costs incurred by multiple local governments or agencies exceed $25,000, you must decide among yourselves how the total reimbursement will be divided. | ||||
| 40:40:30.0.1.1.7.2.6.6 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.10 What are temporary emergency measures? | EPA | (a) Temporary emergency measures are actions taken to control or eliminate immediate threats to human health and the environment. (b) Examples of temporary emergency measures are: (1) Site security; (2) Controlling the source of contamination; (3) Containing the release to prevent spreading; (4) Neutralizing or treating pollutants released; and (5) Controlling contaminated runoff. | ||||
| 40:40:30.0.1.1.7.2.6.7 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.11 What costs are allowable? | EPA | (a) Reimbursement under this part does NOT supplant funds you normally provide for emergency response. Allowable costs are only those necessary for you to respond effectively to a specific incident that is beyond what you might normally respond to. (b) Examples of allowable costs are: (1) Disposable materials and supplies you acquired and used to respond to the specific incident; (2) Payment of unbudgeted wages for employees responding to the specific incident (for example, overtime pay for response personnel); (3) Rental or leasing of equipment you used to respond to the specific incident (for example, protective equipment or clothing, scientific and technical equipment) (Note: rental costs are only allowable for the duration of your response; once you complete the response to the specific incident, further rental costs are NOT allowable); (4) Replacement costs for equipment you own that is contaminated or damaged beyond reuse or repair, if you can demonstrate that the equipment is a total loss and that the loss occurred during the response (for example, self-contained breathing apparatus irretrievably contaminated during the response); (5) Decontamination of equipment contaminated during the response; (6) Special technical services specifically required for the response (for example, costs associated with the time and efforts of technical experts/specialists that are not on your staff); (7) Other special services specifically required for the response (for example, utilities); (8) Laboratory costs of analyzing samples that you took during the response; (9) Evacuation costs associated with the services, supplies, and equipment that you procured for a specific evacuation; and (10) Containerization or packaging cost and transportation and disposal of hazardous wastes. (c) To be allowable, costs must: (1) NOT be higher than what a careful person would spend for similar products or services in your area; and (2) Be consistent with CERCLA and the federal cost principles outlined in OMB Circular A-87, “C… | ||||
| 40:40:30.0.1.1.7.2.6.8 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.12 What costs are NOT allowable? | EPA | (a) Costs that are NOT allowable are expenditures you incur in providing what are traditionally local services and responsibilities. Examples include: (1) Routine firefighting; (2) Preparing contingency plans; (3) Training; and (4) Response drills and exercises. (b) Costs that are NOT allowable also include items such as supplies, equipment, and services that you routinely purchase to maintain your ability to respond effectively to hazardous releases when they occur. Examples of other costs that are NOT allowable are: (1) Purchase or routine maintenance of durable equipment expected to last one year or more, except when contaminated or damaged as described in § 310.11(b)(4) and (b)(5); (2) Materials and supplies you did NOT purchase specifically for the response; (3) Rental costs for equipment that you own or that another unit of local government owns; (4) Employee fringe benefits; (5) Administrative costs for filing reimbursement applications; (6) Employee out-of-pocket expenses normally provided for in your operating budget (for example, meals or fuel); (7) Legal expenses you may incur due to response activities, including efforts to recover costs from PRPs; and (8) Medical expenses you incur due to response activities. | ||||
| 40:40:30.0.1.1.7.2.7.10 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.14 Must I try to recover my costs from those potentially responsible for the emergency? | EPA | Yes. Before applying for reimbursement from EPA, you must try to recover your costs from all known potentially responsible parties (PRPs). After you ask them for payment, you should give PRPs 60 days either to pay you, express their intent to pay you, or indicate willingness to negotiate. You must also try to get reimbursed by other sources (for example, your insurance company or your state). If you are not successful, you must certify on your reimbursement application that you made a good-faith, reasonable effort to recover your costs from other sources before applying to EPA. If you recover any portion of the costs from these sources after you receive reimbursement from us, you must return the recovered amount to EPA. | ||||
| 40:40:30.0.1.1.7.2.7.11 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.15 How do I apply for reimbursement? | EPA | [63 FR 8286, Feb. 18, 1998, as amended at 70 FR 56577, Sept. 28, 2005; 80 FR 77578, Dec. 15, 2015] | (a) You must apply for reimbursement on EPA Form 9310-1, shown in appendix III to this part. (b) You must submit your request within one year of the date you complete the response for which you request reimbursement. If you submit your application late, you must include an explanation for the delay. We will consider late applications on a case-by-case basis. (c) Your application must be signed by the highest ranking official of your local government (for example, mayor or county executive), or you must include a letter of delegation authorizing a delegate to act on his or her behalf. (d) Mail your completed application and supporting data to the LGR Project Officer, (5401A), Office of Emergency Management, Office of Land and Emergency Management, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460. | |||
| 40:40:30.0.1.1.7.2.7.12 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.16 What kind of cost documentation is necessary? | EPA | Cost documentation must be adequate for an audit. At a minimum, you must: (a) Include a description of the temporary emergency measures for which you request reimbursement; (b) Specify the local agency that incurred the cost, (such as, the Town Fire Department, the County Health Department, or the City Department of Public Works); (c) Include invoices, sales receipts, rental or leasing agreements, or other proof of costs you incurred; and (d) Certify that all costs are accurate and that you incurred them specifically for the response for which you are requesting reimbursement. | ||||
| 40:40:30.0.1.1.7.2.7.13 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.17 Are there any other requirements? | EPA | (a) You must certify that reimbursement under this regulation does not supplant local funds that you normally provide for emergency response. This means that the reimbursement you request is for costs you would not normally incur; rather, they are for significant, unanticipated costs related to a specific incident beyond what you normally respond to. (b) You must also certify that your response actions are not in conflict with CERCLA, the National Contingency Plan (NCP), and the local emergency response plan prepared by your Local Emergency Planning Committee, if there is one. If you need help with this requirement, contact the LGR Help line (800-431-9209) or your EPA regional office. (c) You, as a local government, should be included in the local emergency response plan completed by your LEPC, as section 303(a) of EPCRA requires. This does not apply if your State Emergency Response Commission (SERC) has not established an LEPC responsible for the emergency planning district(s) that encompasses your geographic boundaries. | ||||
| 40:40:30.0.1.1.7.2.7.14 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.18 How will EPA evaluate my application? | EPA | (a) When we receive your application, we will make sure it meets all requirements of this section. If your request is incomplete or has significant defects, we will contact you for additional information. You should provide any additional information within 90 days. If you don't provide requested information within a year, we may deny your application. (b) If your application meets all requirements, we will consider whether the costs claimed are allowable and reasonable. We will then send you written notification of our decision to award or deny reimbursement in full or in part. | ||||
| 40:40:30.0.1.1.7.2.7.15 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.19 Under what conditions would EPA deny my request? | EPA | We may deny your reimbursement request in full or in part if: (a) Your records, documents, or other evidence are not maintained according to generally accepted accounting principles and practices consistently applied; (b) The costs you claim are NOT reasonable or allowable, that is, they are higher than what a careful person would spend for similar products or services in your area; or (c) You do not supply additional information within one year from when we request it; and (d) Reimbursement would be inconsistent with CERCLA section 123, or the regulations in this part. | ||||
| 40:40:30.0.1.1.7.2.7.16 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.20 What are my options if EPA denies my request? | EPA | If we deny your request because you failed to meet a requirement in this regulation, you may request, in writing, that EPA grant an exception. You may also file a request for an exception with your initial application. In your request for an exception, you must state the requirement you cannot comply with and the reasons why EPA should grant an exception. We will grant exceptions only if you establish good cause for the exception and if granting the exception would be consistent with section 123 of CERCLA. | ||||
| 40:40:30.0.1.1.7.2.7.17 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.21 How does EPA resolve disputes? | EPA | (a) The EPA reimbursement official's decision is final EPA action unless you file a request for review by registered or certified mail within 60 calendar days of the date you receive our decision. Send your request for review to the address given in § 310.15(d). (b) You must file your request for review with the disputes decision official identified in the final written decision. (c) Your request for review must include: (1) A statement of the amount you dispute; (2) A description of the issues involved; (3) A statement of your objection to the final decision; and (4) Any additional information relevant to your objection to EPA's decision. (d) After filing for review: (1) You may request an informal conference with the EPA disputes decision official; (2) You may be represented by counsel and may submit documentary evidence and briefs to be included in a written record; and (3) You will receive a written decision by the disputes decision official within 45 days after we receive your final submission of information unless the official extends this period for good cause. | ||||
| 40:40:30.0.1.1.7.2.7.9 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.13 Do I need to notify anyone while the response is underway? | EPA | No. You should notify EPA, the National Response Center, or use another established response communication channel, but it is not a requirement for reimbursement. Telephone numbers for EPA regional offices and the NRC are in appendix II to this part. | ||||
| 40:40:30.0.1.1.7.2.8.18 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.22 What records must I keep? | EPA | (a) If you receive reimbursement under the regulations in this part, for three years you must keep all cost documentation and any other records related to your application. You must also provide EPA access to those records if we need them. (b) After three years from the date of your reimbursement, if we have NOT begun a cost recovery action against a potentially responsible party, you may dispose of the records. You must notify EPA of your intent to dispose of the records 60 days before you do so, and allow us to take possession of these records beforehand. | ||||
| 40:40:30.0.1.1.7.2.8.19 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.23 How will EPA rank approved requests? | EPA | [63 FR 8286, Feb. 18, 1998, as amended at 69 FR 18803, Apr. 9, 2004] | (a) If necessary, EPA will rank approved reimbursement requests according to the financial burden the response costs impose on the local governments. We will estimate your financial burden by calculating the ratio of your allowable response costs to your annual per capita income adjusted for population. We will make adjustments for population so that a large city with a low per capita income will not necessarily receive a higher rank than a small town with a slightly higher per capita income. We will also consider other relevant financial information you may supply. (b) We will use the per capita income and population statistics published by the U.S. Department of Commerce, Bureau of the Census, in Current Population Reports, Local Population Estimates, Series P-26, “1988 Population and 1987 Per Capita Income Estimates for Counties and Incorporated Places,” Vols. 88-S-SC, 88-ENC-SC, 88-NE-SC, 88-W-SC, 88-WNC-SC, March 1990. The Director of the Federal Register has approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. Copies are available from the Bureau of the Census, Office of Public Affairs, Department of Commerce, Constitution Avenue, NE., Washington, DC 20230 (1-202-763-4040). You may review a copy at the U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) Larger ratios receive a higher rank. We will reimburse requests with the highest ranks first. Once we rank your request, we will either: (1) Reimburse the request; or (2) Hold the request for reconsideration once additional funding is available. (d) The EPA reimbursement official will give you a written decision on whether the request will be reimbursed or held for future reconsideration. | |||
| 40:40:30.0.1.1.7.2.8.20 | 40 | Protection of Environment | I | J | 310 | PART 310—REIMBURSEMENT TO LOCAL GOVERNMENTS FOR EMERGENCY RESPONSE TO HAZARDOUS SUBSTANCE RELEASES | B | Subpart B—Provisions | § 310.24 What happens if I provide incorrect or false information? | EPA | (a) You must not knowingly or recklessly make any statement or provide any information in your reimbursement application that is false, misleading, misrepresented, or misstated. If you do provide incorrect or false information, and EPA relies on that information in making a reimbursement decision, we may deny your application and withdraw or recover the full amount of your award. In such a case, we would give you written notice of our intentions. (b) If you, as a reimbursement applicant or someone providing information to the applicant, knowingly give any false statement or claim as part of any application for reimbursement under section 123 of CERCLA, you may be subject to criminal, civil, or administrative liability under the False Statement Act (Pub. L. 97-398, 18 U.S.C. 1001) the False Claims Act (Pub. L. 99-562, 31 U.S.C. 3729), and the Program Fraud and Civil Remedies Act (Pub. L. 99-509, 31 U.S.C. 3801). | ||||
| 46:46:8.0.1.8.24.1.12.1 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.1 Definitions. | FMC | [46 FR 37694, July 22, 1981, as amended at 69 FR 31901, June 8, 2004] | For purposes of this subpart A: (a) The 1958 Act means the Maritime Academy Act of 1958, Pub. L. 85-672. (b) Act means the Maritime Education and Training Act of 1980, Pub. L. 96-453, as amended. (c) Administration means the Maritime Administration, United States Department of Transportation. (d) Agreement means an agreement between a State, or Territorial or Regional maritime academy or college and the Maritime Administrator, Department of Transportation as authorized by the 1958 Act or the Act and set forth in § 310.13 of this part. (e) Secretary means Secretary of Transportation. (f) Maritime Administrator means the Maritime Administrator, Department of Transportation. (g) Cadet means cadet enrolled in the United States Maritime Service and in good standing at a State or Territorial or Regional maritime academy or college meeting the requirements of the 1958 Act. (h) Commanding Officer means the Commanding Officer of a training ship furnished by the Administration. (i) Cost of Education Provided means the financial costs incurred by the Federal Government in providing student incentive payments for students at the State maritime academies. (j) Deputy means the Deputy Maritime Administrator, Department of Transportation. (k) Maritime Service means the United States Maritime Service. (l) Midshipman means a student in good standing at a State maritime academy or college who has accepted midshipman status in the United States Naval Reserve (including the Merchant Marine Reserve, United States Naval Reserve) under the Act. (m) Officers means all officers and faculty employed by a State maritime academy or college. (n) Region Director means the Director of the Administration's region office in which a School is located or in which a training ship is located. (o) School means State or Territorial or regional maritime academy or college meeting the requirements of the Act. (p) Superintendent means the superintendent or president of a School. (q) Supervisor means the e… | |||
| 46:46:8.0.1.8.24.1.12.10 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.10 Discipline and dismissal. | FMC | (a) Each School shall establish and publish rules and regulations governing Cadet and Midshipman discipline and providing for a demerit system for infractions of these rules and regulations. Serious or excessive violations of the rules and regulations by a Cadet or Midshipman may be considered as evidence of inaptitude for the demanding career of a merchant marine officer and warrant dismissal by the school. (b) Each Cadet or Midshipman shall, upon admission to the School, be furnished a copy of the School's rules and regulations. (c) Any Cadet or Midshipman placed on probation for failure to meet the conduct requirements of the school may, at the discretion of the Superintendent, be listed as not in good standing for any period not to exceed six (6) months for the purpose of § 310.7(a)(5). | ||||
| 46:46:8.0.1.8.24.1.12.11 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.11 Cadet uniforms. | FMC | Cadet uniforms shall be supplied at the school in accordance with the uniform regulations of the School. Those regulations shall prescribe a distinctive insignia or device approved by the Maritime Administrator. | ||||
| 46:46:8.0.1.8.24.1.12.12 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.12 Scope and effect. | FMC | (a) If any provisions of this subpart conflict with laws and regulations of the State, the appropriate State authorities shall notify the Maritime Administrator in writing of such conflict and pertinent circumstances. The Maritime Administrator, as a matter of discretion, shall take, or not take, any action determined appropriate under the 1958 Act or the Act. (b) The Maritime Administrator may, after consultation with the Superintendents of the schools issue binding executive instructions supplementing this subpart. | ||||
| 46:46:8.0.1.8.24.1.12.13 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.12-1 Form of Agreement. | FMC | [70 FR 28833, May 19, 2005] | The form of agreement between the Maritime Administrator and schools for annual maintenance and support payments, Federal student subsistence and incentive payments and fuel assistance under the 1958 Act and the Act may be obtained from the Office of Policy and Plans, Maritime Administration, 400 7th St., SW., Washington, DC 20590. | |||
| 46:46:8.0.1.8.24.1.12.2 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.2 Federal assistance. | FMC | (a) The Maritime Administrator may enter into agreements with the present or later established schools (not more than one such school in each State or Territory) meeting the requirements of the Act to make annual payments, for not in excess of four (4) years in the case of each such agreement, to be used for the maintenance and support of such Schools. The amount of each such annual payment shall be not less than the amount furnished to such School for its maintenance and support by the State or Territory in which such academy is located or, in the case of a Regional maritime academy an amount equal to the amount furnished to such academy for its maintenance and support by all States or Territories, r both, cooperating to support such School, but shall not exceed $100,000. However, the amount shall not exceed $25,000, if such academy does not meet the requirements of subsection 1304(f)(2) of the Act. (b) Pursuant to the provisions of section 1304(c) of the Act, The Maritime Administrator, may furnish to any State or Territory of the United States for use as a Training Ship by a school any suitable vessel that is under his or her jurisdiction, obtain such vessel from any department or agency of the United States, or may construct and furnish a suitable vessel, if such vessel is not available. (c) The Maritime Administrator may pay to any School the amount of the costs of all fuel consumed by a Training Ship furnished under the provisions of section 1304(c)(1) of the Act while such vessel is being used for training purposes by such a School, if such funds have been appropriated and are available for that purpose. (d) As a condition to receiving any payments or the use of any Training Ship under the provisions of the Act, the school shall comply with the requirements of the Act and this subpart and shall agree in writing to conform to such requirements. (e) As a further condition to receiving any payments or the use of any Training Ship, a School shall agree that, with respect to the training program for merchan… | ||||
| 46:46:8.0.1.8.24.1.12.3 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.3 Schools and courses. | FMC | [46 FR 37694, July 22, 1981, as amended at 49 FR 13365, Apr. 4, 1984; 69 FR 31901, June 8, 2004] | (a) Schools with Federal aid. The following schools are presently operating with Federal aid under the 1958 Act or the Act: California Maritime Academy Maine Maritime Academy Massachusetts Maritime Academy State University of New York Maritime College Texas Maritime College of the Texas A&M University at Galveston The Great Lakes Maritime Academy California Maritime Academy Maine Maritime Academy Massachusetts Maritime Academy State University of New York Maritime College Texas Maritime College of the Texas A&M University at Galveston The Great Lakes Maritime Academy (b) General rules for operation of a School. (1) The Schools shall maintain adequate berthing, messing and classroom instruction facilities ashore, or have plans to establish same at the earliest possible time, unless prevented from doing so by conditions beyond the control of the School. During a period a school is implementing an approved plan, Cadets may be housed and instructed on a Training Ship. However, the approved plan may include the ongoing use of the Training Ship as an instructional and laboratory facility and for the berthing of entering class cadets for a period not to exceed six months for purposes of shipboard indoctrination. (2) The School shall arrange for the Cadet or Midshipman to take the United States Coast Guard original licensing examination prior to the date of graduation. (3) As a condition to receiving payments of any amount allowable by the 1958 Act and the Act in excess of $25,000 for any year, a School shall agree to admit student residents of other States to the extent of at least ten percent (10%) of each entering class, if such out-of-State students apply for admission and are otherwise qualified for such admission. The calculation of residents of other States shall exclude residents of foreign countries, but shall include residents of Territories and possessions of the United States (including the Commonwealth of Puerto Rico). (4) Upon the request of the Administration a school shall fu… | |||
| 46:46:8.0.1.8.24.1.12.4 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.4 Training Ship. | FMC | The Administration may furnish a Training Ship, if such is available, to any School. Training Ships which may be designated for use by a School will be delivered to the School at a location determined by the Administration, in condition found to be in class by the American Bureau of Shipping and certificated by the U.S. Coast Guard. If a Training Ship is not available, adequate cruising facilities shall be the responsibility of the State and its School. The furnishing of a Training Ship shall be subject to the following terms and conditions: (a) General provisions. (1) The State, acting through the School shall exercise reasonable care to safeguard the interests of the Administration and avoid (i) injury to any person aboard the Training Ship, and (ii) loss and damage of every nature with respect to the Training Ship. Also, the school shall have reasonable layup procedures during noncruise status of the Training Ship. (2) Excerpts from log books and reports shall be submitted as directed by the Supervisor. (3) Initial telegraphic or telephonic reports shall be made promptly to the Supervisor and the appropriate Region Director in the event of an accident causing (i) serious injury to any person, or to the Training Ship, or (ii) damage inflicted by the Training Ship upon any other ship or other property. Such reports shall be followed by complete written details of the occurrence. (4) The Supervisor shall determine whether or not the berth of the Training Ship at the base in its home port is suitable from the standpoint of safe mooring. When the Training Ship is not on cruise, the Commanding Officer or Superintendent shall keep the Supervisor informed of the location of the Training Ship and any contemplated change of berth. (5) The following notice shall be posted conspicuously aboard each Training Ship furnished to a State for use by a School: This training ship is the property of the United States of America. It is furnished to the State of ________ by the Department of Transportation, Maritime Administ… | ||||
| 46:46:8.0.1.8.24.1.12.5 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.5 Personnel. | FMC | [46 FR 37694, July 22, 1981, as amended at 47 FR 25530, June 14, 1982; 49 FR 13365, Apr. 4, 1984] | (a) Selection and appointment of Superintendent and faculty by State authorities. (1) The State shall select and appoint the Superintendent of a School in accordance with qualifications established by appropriate State authorities. The State shall notify the Maritime Administrator whenever a new Superintendent is appointed and furnished with appropriate background information on the appointee for informational purposes. (2) The State shall appoint faculty members in disciplines other than engineering and navigation on the basis of the same criteria used in the employment of such personnel in State-supported colleges and universities throughout the State. Faculty members in navigation and engineering courses, including steam and diesel, shall meet appropriate academic and practical experience standards adopted by the school and approved by the Administration. (b) Personnel for Training Ships —(1) Commanding Officer. The Commanding Officer shall hold a valid Master's Ocean, Unlimited Tonnage license including Radar Observer endorsement issued by the United States Coast Guard and shall have served at least two (2) years as Master, Chief Officer, Commanding Officer, or Executive Officer either (i) on oceangoing vessels under the authority of said Master's Ocean, Unlimited Tonnage license, or (ii) in the case of sea service as a member of the Uniformed Services of the United States, on ships accepted by the United States Coast Guard as equivalent for qualifying service for issue of a Master's Ocean, Unlimited Tonnage license. (2) Chief Engineer. The Chief Engineer must hold a valid Chief Engineer's (Steam) Ocean, Unlimited Horsepower license, issued by the United States Coast Guard and have served as Chief Engineer of an oceangoing steamship of comparable horsepower to that of the particular Training Ship. (3) Watch Officers. Both Deck and Engineer Watch Officers in charge of a watch, underway, shall hold valid Ocean, Unlimited Tonnage licenses, issued by the United States Coast Guard, in their particular… | |||
| 46:46:8.0.1.8.24.1.12.6 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.6 Entrance requirements. | FMC | [46 FR 37694, July 22, 1981, as amended at 48 FR 24080, May 31, 1983] | (a) Enrollment prior to April 1, 1982. A candidate for admission to a school who wishes to be considered for Federal student subsistence payments shall: (1) Be a citizen of the United States. (2) Be obligated to (i) complete the Naval Science curriculum (ii) take all necessary and positive steps to obtain a commission as ensign in the United States Naval Reserve, (iii) apply before graduation for such commission, and (iv) accept such commission if offered. A breach of this agreement will result in termination of cadet status and of Federal student subsistence payments, and may lead to legal action for recovery of all past such payments. The requirements of this paragraph shall not apply at The Great Lakes Maritime Academy. (3) Be obligated to sit for the appropriate licensing examination of the United States Coast Guard. A breach of this agreement will result in termination of cadet status and of Federal student subsistence payments, and may lead to legal action for recovery of all past such payments. (4) Meet the physical standards specified by the United States Coast Guard for original licensing as a merchant marine officer. The written certification of the Superintendent of the school, based on a physical examination by a doctor, the results of which are on record at the school, that a candidate meets these requirements, will be acceptable to the Administration. (5) Possess a secondary school education or equivalent, satisfactory for admission as an undergraduate, to colleges or universities under control of the State in which the school is located. (6) Meet requirements established by the school in regard to such criteria as the individual's secondary school grades, rank in graduating class, aptitude, achievement, and qualities of leadership. (b) Enrollment on or after April 1, 1982. A candidate for admission to a school who wishes to be considered for the Federal student incentive payments shall: (1) Meet the requirements of paragraphs (a) (1), (4), (5), and (6) of this section. (2) Be at least … | |||
| 46:46:8.0.1.8.24.1.12.7 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.7 Federal student subsistence allowances and student incentive payments. | FMC | [46 FR 37694, July 22, 1981, as amended at 48 FR 24080, May 31, 1983; 49 FR 13365, Apr. 4, 1984; 65 FR 39558, June 27, 2000; 66 FR 36176, July 11, 2001; 69 FR 31901, June 8, 2004; 69 FR 61606, Oct. 20, 2004; 70 FR 28833, May 19, 2005] | (a) Subsistence allowances —(1) Selection and allocation. In accordance with the Administration's established freshmen subsidy allocation for each School, the school shall select the individuals in its new entering class who will be enrolled in the United States Maritime Service as cadets and start to receive Federal student subsistence payments for uniforms, textbooks and subsistence as provided in the 1958 Act. The freshman subsidy allocations for each school are as follows: California Maritime Academy 99; Maine Maritime Academy 135; Massachusetts Maritime Academy 69; State University of New York Maritime College 200; Great Lakes Maritime Academy 45; and the Texas Maritime College 32. Each student who meets the entrance requirements in § 310.6(a) and applies for enrollment in the United States Maritime Service shall be entitled to consideration for a student subsistence payment at a rate and under the conditions in the 1958 Act. The list identifying the selected students shall be forwarded to the Administration on or before October 31, 1981. The Federal student subsistence payments will be paid to the School while a cadet is in attendance but not in excess of four (4) academic years for any one student. (2) Resignation or disenrollment. There will be no substitution for students removed or dropped from the list of those originally receiving Federal student subsistence payments. Subsidized students who resign or are disenrolled from a school shall not, on subsequent reenrollment, be in a position to reclaim their subsidy status. (3) Selection criteria; rate of payment. The selection of the students to receive such payments shall be made by the School in accordance with criteria established by the School, with the prior approval of the Administration. The rate of Federal student subsistence payments will be determined by the Administration according to the 1958 Act or the Act. (4) ROTC enrollment. Subsidized cadets who make a commitment to an Armed Force Reserve Officer Training Corps will be removed … | |||
| 46:46:8.0.1.8.24.1.12.8 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.8 Leave. | FMC | [48 FR 24081, May 31, 1983] | (a) Enrolled before April 1, 1982. Limitations on cadet leave, without loss of Federal student subsistence, with the specific limits to be set at the discretion of the Superintendent on an academic year basis, are: (1) If hospitalized, sick at home, or confined in the sick bay, leave shall not exceed four (4) months. (2) For an emergency due to the serious illness, injury or death of a very near relative, leave shall not exceed seven (7) days. (3) Annual leave shall not exceed thirty (30) days. (4) Christmas and Easter leave shall not exceed a total of twelve (12) days, and leave may be granted for all legal holidays—Federal and state. This leave is in addition to that granted in paragraph (a)(3) of this section. (5) Leave in addition to that provided in paragraphs (a) (3) and (4) of this section may be granted only if approved in advance by the Supervisor, upon direct request by the Superintendent. (b) Enrolled on or after April 1, 1982. Midshipmen will be granted leave without loss of incentive payments as follows: (1) Medical leave, as authorized by the school, not to exceed four (4) months. (2) Christmas and Easter leave and all legal holidays—Federal and state—as authorized by the school. This leave is in addition to that granted in paragraph (b)(3) of this section. (3) Excused absences, as authorized by the school, not to exceed thirty (30) days per academic year. All unauthorized leave and all excused absences in excess of thirty (30) days will result in loss of incentive payments. Midshipmen receiving student incentive payments may be granted leaves of absence without pay, as approved by the Superintendent, for periods not to exceed one (1) academic year at a time. Midshipmen in a pay status will only be granted a leave of absence if they continue to meet all requirements for graduation in this part, including age requirements. | |||
| 46:46:8.0.1.8.24.1.12.9 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | A | Subpart A—Regulations and Minimum Standards for State, Territorial or Regional Maritime Academies and Colleges | § 310.9 Medical attention and injury claims. | FMC | [46 FR 37694, July 22, 1981, as amended at 48 FR 24081, May 31, 1983] | (a) Medical attention and hospitalization. The school shall be responsible for arranging that a medical officer shall be attached or on call to the school. During the cruise, the School shall assign a medical officer to the Training Ship. (b) Compensation claims of Cadets or Midshipmen. Compensation claims for personal injuries or death sustained by a federally-assisted cadet or midshipman in the performance of official duty shall be forwarded to the Supervisor for transmission to the Office of Workers' Compensation Programs. The Supervisor shall furnish necessary forms. (c) Medical care and compensation for Officers and other personnel. Officers and other personnel of the School, and of the Training Ship may avail themselves of any medical facilities furnished by the State or Federal Government for which they qualify. See, for example, 42 CFR part 32. Such persons who are not Federal employees shall look to the State alone for pay, allowances, compensation and other benefits during injury or illness. | |||
| 46:46:8.0.1.8.24.3.12.1 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.50 Purpose. | FMC | The regulations in this subpart govern the nomination, admission and appointment of midshipmen to the United States Merchant Marine Academy, | ||||
| 46:46:8.0.1.8.24.3.12.10 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.59 Courses of instruction. | FMC | (a) At Academy. Three major curriculums are offered: Nautical Science, for the preparation of deck officers; Marine Engineering, for the preparation of engineering officers; and the Dual License Program, a combined course which leads to licenses in both specialties. All midshipmen who are citizens shall take naval science courses prescribed by the Department of the Navy. All curriculums include general education courses and electives. (b) Sea year. Midshipmen spend one-half of their sophomore (third class) year and one-half of their junior (second class) year training at sea aboard one or more merchant vessels. In addition to practical shipboard assignments, midshipmen are required to complete written study assignments incorporating material from the major segments of the Academy curriculums. | ||||
| 46:46:8.0.1.8.24.3.12.11 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.60 Training on subsidized vessels. | FMC | [47 FR 21812, May 20, 1982, as amended at 52 FR 21534, June 8, 1987] | All operators of subsidized merchant vessels, in accordance with contractual arrangements, are required to employ for training at least two midshipmen, as assigned by the Superintendent of the Academy, which employment shall be in accordance with the following provisions. (a) Work assignments. All practical work assignments for midshipmen shall be in accordance with courses prescribed by the Superintendent of the Academy. (b) Working hours. In order to permit midshipmen to complete their academic assignments, vessel employers shall not require midshipmen to work more than 8 hours each day. Midshipmen shall devote at least 3 hours of their own time each day to study. (c) Pay. Midshipmen shall receive pay while employed aboard merchant vessels directly from the steamship company employers at the same rate received by cadets and midshipmen at the other Federal academies. A change in the rate of pay for midshipmen at the Academy shall occur after a change in the rate of pay for cadets/midshipmen at the other Federal academies and shall be effective either on June 15th or on December 15th of the same calendar year, whichever occurs first. While aboard ship, they shall be berthed in single-occupancy rooms or in rooms with other midshipmen in that part of the vessel designated for licensed officers (or in first-class passenger quarters) and shall mess with the licensed officers. The steamship company employers shall also pay the midshipmen such subsistence and room allowance in port, transportation allowances, and other bonuses or allowances as are paid to the licensed officers of the vessel in which the midshipmen are employed. (d) Berthing and messing. While aboard ship, midshipmen shall be berthed in single-occupancy rooms or in rooms with other midshipmen in that part of the vessel designated for licensed officers (or in first-class passenger quarters) and shall mess with the licensed officers. | |||
| 46:46:8.0.1.8.24.3.12.12 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.61 Training on other vessels and by other facilities or agencies. | FMC | The Administrator may arrange for training of midshipmen on Government-owned vessels, in cooperation with other governmental and private agencies, and on other vessels documented under the laws of the United States if the owner of such vessel cooperates in such use. Midshipmen may be assigned for training in shipyards, plants, and industrial and educational organizations for instructional purposes only. | ||||
| 46:46:8.0.1.8.24.3.12.13 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.62 Allowances and expenses; required deposit. | FMC | (a) Items furnished. Each midshipman shall receive: Free tuition, quarters and subsistence; limited medical and dental care; and certain travel expenses, in accordance with chapter 5, part A, of the Joint Travel Regulations For Members Of Uniform Services, Vol. 1 (U.S. Department of Defense publication, Serial No. 0516-LP-255-0265), while traveling under official Academy orders. (b) Required Deposit. Prior to admission to the Academy, each midshipman shall make a specified deposit, as established by Academy regulations, to help defray the cost of items and services generally of a personal nature which are not provided by the Academy. Additional deposits, as prescribed in Academy regulations, are required to be made in subsequent years. Failure to make any required deposit will result in denial of admission, suspension or disenrollment. | ||||
| 46:46:8.0.1.8.24.3.12.14 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.63 Uniforms and textbooks. | FMC | The Academy shall supply midshipmen uniforms and textbooks in accordance with Academy regulations. | ||||
| 46:46:8.0.1.8.24.3.12.15 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.64 Privileges. | FMC | (a) Midshipmen may be granted a leave of absence of approximately four (4) weeks after completing each of the first, second and third years of training. (b) Classes and exercises are suspended on New Year's Day, Washington's Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans' Day, Thanksgiving Day, Christmas Day and such other days as may be designated by the President as holidays for Federal employees. (c) Midshipmen may be granted approximately 2 weeks leave during the period which includes Christmas Day and New Year's Day. (d) Liberty and other privileges are granted to midshipmen meriting them under Academy regulations. (e) Relatives and friends of midshipmen may visit at the Academy during such ours as the Superintendent may prescribe. (f) There shall be a Ship's Service Store maintained as a non-appropriated fund activity at the Academy primarily to serve the needs of the midshipmen. | ||||
| 46:46:8.0.1.8.24.3.12.16 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.65 Graduation. | FMC | (a) Classes enrolled prior to April 1, 1982. (1) A midshipman will be graduated from the Academy upon the successful attainment of the following requirements: (i) Completion of the required course of study; (ii) Fulfillment of the requirements for a license as an officer in the merchant marine of the United States; (iii) Filing for a commission in the USNR (including the Merchant Marine Reserve, USNR); and (iv) Compliance with the prescribed midshipman disciplinary and honor systems. (2) Graduates receive the degree of Bachelor of Science and a U.S. Coast Guard license either as third officer or third assistant engineer or both. They also may be granted commissions as Ensign, USNR (including the Merchant Marine Reserve, USNR) by the Department of the Navy. (3) In return for the education received at Government expense, each applicant shall sign an agreement to serve in one of the following categories immediately after graduation: (i) Sail on his or her license at sea for not less than six (6) months each year for three (3) consecutive years; or (ii) Sail on his or her license at sea for not less than four (4) months each year for four (4) consecutive years; or (iii) Apply for and serve on active duty for training on board a U.S. Navy ship for a minimum period of thirty (30) consecutive days each year for a period of three (3) consecutive years, and be either employed ashore for the balance of each year in some phase of the maritime industry or engaged in full-time graduate studies related to the maritime field; or (iv) Apply for and serve on full-time active duty as a commissioned officer in a uniformed service of the United States for a period of 3 consecutive years. (b) Classes enrolled after April 1, 1982. (1) A midshipman will be graduated from the Academy upon the successful attainment of the following requirements: (i) Completion of the required course of study; (ii) Fulfillment of the requirements for a license as an officer in the merchant marine of the United States; (iii) Application f… | ||||
| 46:46:8.0.1.8.24.3.12.17 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.66 Foreign students. | FMC | [47 FR 21812, May 20, 1982, as amended at 60 FR 44439, Aug. 28, 1995] | (a) Appointments from the Trust Territory of the Pacific Islands. The Administrator may permit, upon designation by the Secretary of the Interior, individuals from the Trust Territory of the Pacific Islands to receive instruction at the Academy. Not more than 4 such individuals may receive instruction at any one time. Residents of the Trust Territory of the Pacific Islands are neither citizens nor nationals of the United States. (b) Appointments from the Northern Mariana Islands. The Governor of the Northern Mariana Islands may nominate individuals for one position each year allocated to residents of the Northern Mariana Islands. Such residents are neither citizens nor nationals of the United States. (c) Appointments from nations located in the Western Hemisphere. The President may designate individuals from nations located in the Western Hemisphere, other than the United States, to receive instruction at the Academy. Not more than 12 individuals may receive instruction under this paragraph at any one time, and not more than 2 individuals receiving instruction under this paragraph at any one time may be from the same nation. The Secretary may allow, upon approval of the Secretary of State, additional individuals from the Republic of Panama to receive instruction at the Academy on a reimbursable basis. (d) Appointments from nations other than the United States. In addition to the appointments under paragraphs (a), (b) and (c) of this section, the Administrator, with the approval of the Secretary of State, may permit individuals from any nations other than the United States to receive instruction at the Academy. Not more than 30 such individuals may receive instruction at any one time. (e) Candidate Sponsors. A representative of the Administration or a diplomatic representative of the United States in the candidate's country of residence will be designated as the Candidate's Sponsor. It will be the responsibility of the Candidate's Sponsor to act as liaison with the appropriate officials of the candid… | |||
| 46:46:8.0.1.8.24.3.12.18 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.67 Academy regulations. | FMC | The Superintendent of the Academy is delegated authority to issue all regulations necessary for the accomplishment of the Academy's mission. | ||||
| 46:46:8.0.1.8.24.3.12.2 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.51 Definitions. | FMC | [47 FR 21812, May 20, 1982, as amended at 69 FR 31902, June 8, 2004] | (a) Academy means the United States Merchant Marine Academy. (b) Act means the Maritime Education and Training Act of 1980, Pub. L. 96-453, 94 Stat. 1997, as subsequently amended, 46 App. U.S.C. 1295-1295g. (c) Administration means the Maritime Administration, Department of Transportation. (d) Administrator means the Administrator of the Maritime Administration. (e) Citizen means an individual who, by birth or naturalization, owes national allegiance to the United States, but the term excludes United States nationals. (f) Cost of Education Provided means the financial costs incurred by the Federal Government for providing training or financial assistance to students at the United States Merchant Marine Academy, including direct financial assistance, room, board, classroom academics, and other training activities. (g) Foreign student means an individual who owes national allegiance to a country or political entity other than the United States, and the term includes United States nationals. (h) NOAA means the National Oceanic and Atmospheric Administration. (i) USNR means the United States Naval Reserve. | |||
| 46:46:8.0.1.8.24.3.12.3 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.52 General. | FMC | (a) Midshipmen are appointed to the Academy for training to prepare them to become officers in the U.S. merchant marine. The Academy, located at Kings Point, New York, is maintained by the Government as a part of the Administration. After successful completion of the 4-year course of study, a graduate of the Academy shall receive a Bachelor of Science degree and a merchant marine license as either a third officer or third assistant engineer (or both licenses upon completion of a special curriculum and passing the respective license examinations) issued by the U.S. Coast Guard. If qualified, a graduate may be commissioned as an officer in a reserve component of an armed force of the United States. (b) Midshipmen entering the Academy after April 1, 1982, are required by the Act to sign an agreement committing them to service obligations following the date of graduation. The terms of the service obligation contract are set forth in § 310.58 of this subpart. | ||||
| 46:46:8.0.1.8.24.3.12.4 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.53 Nominations and vacancies. | FMC | [47 FR 21812, May 20, 1982, as amended at 51 FR 17741, May 15, 1986; 60 FR 44438, Aug. 28, 1995] | (a) Nominating officials. (1) Each Senator and Member of the House of Representatives (including delegates from Guam, the Virgin Islands and the District of Columbia and the Resident Commissioner from Puerto Rico), the Panama Canal Commission, the Governor of the Northern Mariana Islands, and the Delegate to the House of Representatives from American Samoa may nominate ten (1) candidates to compete for admission to the Academy. (2) In accordance with the Act (46 U.S.C. 1295b (b)(1)), nominating officials may only nominate candidates who are residents of the State or other geographic area which the particular nominating official represents, as follows: (3) Individuals must be residents of the Trust Territory of the Pacific Islands to qualify for designation by the Secretary of the Interior. (4) Nominating officials may select nominees, and the Secretary of the Interior may select designees, by any method they wish, including a screening examination. (5) Candidates from nations other the United States must be nominated by an official of their home government and have their applications approved by the United States Government official specified in § 310.66 (a), or (c) or (d). (b) Vacancies. (1) The number of vacancies in each entering class allocated to each State is in proportion to the representation in Congress from that State. (2) In each entering class, two vacancies shall be allocated each year for individuals nominated by the Panama Canal Commission; one vacancy each to nominees from Puerto Rico, Guam, Virgin Islands, Northern Marian Islands and American Samoa; and four vacancies to nominees from the District of Columbia. (3) Not to exceed four (4) individuals at any one time may be admitted from the Trust Territory of the Pacific Islands and twelve (12) individuals from nations located in the Western Hemisphere, other than the United States, but not more than two (2) individuals from any one of such nations shall receive training at the same time. (4) The Administrator may permit, upon approval … | |||
| 46:46:8.0.1.8.24.3.12.5 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.54 General requirements for eligibility. | FMC | [47 FR 21812, May 20, 1982, as amended at 49 FR 45858, Nov. 21, 1984] | (a) Citizenship. All candidates shall be citizens of the United States except: (1) Nominees from foreign nations; (2) nominees from the Northern Mariana Islands; (3) designees from the Trust Territory of the Pacific Islands; and (4) nominees from American Samoa, who may be American nationals. No person who is not a citizen shall be entitled to any office or position in the U.S. merchant marine by reason of his or her graduation from the Academy, until such person shall have become a citizen. (b) Age. On July 1 of the year of admission to the Academy, a candidate shall be not less than seventeen (17) years of age and shall not have passed his or her twenty-fifth (25) birthday. (c) Character. A candidate shall be of good moral character. The Administrator may reject the nomination of any candidate whose character is incompatible with the Academy's standards. No person who has been dismissed or compelled to resign from the U.S. Military Academy, the U.S. Naval Academy, the U.S. Air Force Academy, the U.S. Coast Guard Academy, the Academy or a State maritime academy for improper conduct shall be eligible for appointment as a midshipman at the Academy. No person whose last discharge from any armed force was under conditions other than honorable or who has had a merchant mariner document removed or suspended for cause shall be eligible for appointment as a midshipman. (d) Investigation. To be eligible for appointment, all candidates who are United States citizens shall be completely loyal to the United States and shall meet the requirements established by the Department of the Navy for designation as Midshipman, USNR (including the Merchant Marine Reserve, USNR). Candidates for appointment shall execute documents approved by the Administrator for the purpose of a security and suitability investigation. Appointment as a Midshipman, USNR (including the Merchant Marine Reserve, USNR) shall be a condition of admission for an individual who is a citizen. A candidate who is conditionally appointed to the Academy p… | |||
| 46:46:8.0.1.8.24.3.12.6 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.55 Scholastic requirements. | FMC | [47 FR 21812, May 20, 1982, as amended at 85 FR 67302, Oct. 22, 2020] | (a) Academic requirements —(1) Credits. Applicants shall have satisfactorily completed their high school education at an accredited secondary school, or equivalent, and shall present at least 15 units of credit for subjects acceptable to the Academy, comprised of: (i) 7 required units, as follows: (A) 3 units of Mathematics (from algebra, geometry and trigonometry); (B) 3 units of English; and (C) 1 unit of Physics or Chemistry. (ii) 8 other units, preferably chosen from the following fields: (A) Additional mathematics and science; (B) Foreign language; (C) Economics; and, (D) Social science. (2) Evidence of academic work. Before approval of an application, each applicant shall submit evidence showing completion of high school education, or showing that such education will be completed no later than June 30 of the year in which admission is sought. (b) Scholastic examinations —(1) Required entrance examinations. Applicants shall qualify in either the College Board's Scholastic Aptitude Tests (SAT) or the American College Testing Program (ACT) examinations, administered nationally on scheduled dates at convenient testing centers. A candidate electing to use the College Board shall take both the mathematics and the verbal section of the SAT. A candidate electing to use the ACT, shall take all the tests, namely, English, Mathematics, Social Sciences and Natural Sciences. Minimum qualifying scores on the entrance examinations will be determined by the Superintendent of the Academy for each entering class prior to any offers of appointment for the particular class. Any score below the minimum on any one section of an examination shall make the nominee ineligible for admission. All examination costs shall be borne by the applicant. Nominees shall take all the required examinations by the February testing date in the year for which they seek appointment, unless the Academy's Admissions Office grants special authorization to take later examinations. (2) Forwarding test results. Candidates shall be r… | |||
| 46:46:8.0.1.8.24.3.12.7 | 46 | Shipping | II | H | 310 | PART 310—MERCHANT MARINE TRAINING | C | Subpart C—Admission and Training of Midshipmen at the United States Merchant Marine Academy | § 310.56 Physical requirements. | FMC | [47 FR 21812, May 20, 1982, as amended at 55 FR 46952, Nov. 8, 1990] | (a) Physical standards. (1) A candidate shall meet the physical requirements prescribed by the Department of the Navy for appointment as Midshipman, USNR (including the Merchant Marine Reserve, USNR) and the requirements prescribed by the U.S. Coast Guard for original licensing as a third mate and third assistant engineer. All candidates shall have color perception and refractive error within the limits prescribed by the Department of the Navy or by the U.S. Coast Guard, whichever are higher. (2) The requirement to meet these standards is a continuing one and shall apply through graduation from the Academy. Failure to meet the standards while attending the Academy is grounds for, and may lead to disenrollment. Individuals who have completed at least two years of study and, as a result of an accident, illness or other cause (during official duty), fail to meet this requirement may be permitted to remain at the Academy at the discretion of, and under conditions set by, the Administrator. Those individuals permitted to remain through graduation will agree to fulfill aspects of the service obligation which they are capable of, as deemed appropriate by the Administrator. (b) Qualifying physical examinations. All candidates for the Academy shall have a physical and dental examination conducted by a service academy examining facility designated by the Service Academies Central Medical Review Board. The required physical examination shall occur within 1 year preceding the date of admission to the Academy. Although there is no charge for such examination, all expenses (including travel, meals and hotel accommodations) incurred in obtaining such examination shall be borne by the applicant. Candidates may be subject to reexamination upon reporting to the Academy and at any time while attending the Academy. (c) Physical reexamination. A candidate who is rejected for failure to meet the physical requirements may request either a reevaluation of the examination results or a reexamination. A midshipman failing to meet … |
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