	RCRA REVISION CHECKLIST 233E
Remanufacturing exclusion
Less stringent for all states

                  Revisions to the Definition of Solid Waste
                                80 FR 1694-1814
	January 13, 2015
	(RCRA Cluster XXIV, Non-HSWA)

Name of State:	Virginia
State Statutory Authority:	§ 10.1-1402 of the Code of Virginia
Title of Regulations: 	Virginia Hazardous Waste Management Regulations, 9VAC20-60
Effective Date:  Annual Update 2015 effective on January 27, 2016 (Virginia Register, Volume 32, Issue 09)
Date Checklist Completed: 	December 8, 2015

                             FEDERAL REQUIREMENTS

                             FEDERAL RCRA CITATION
                           ANALOGOUS STATE CITATION

                               STATE ANALOG IS:

                                  EQUIV-ALENT

                                     LESS
                                    STRIN-
                                     GENT

                                MORE STRIN-GENT

                               BROADER IN SCOPE

             PART 260 HAZARDOUS WASTE MANAGEMENT SYSTEM:  GENERAL

                             SUBPART B DEFINITIONS

Add "Remanufacturing" to mean: processing a higher-value hazardous secondary material in order to manufacture a product that serves a similar functional purpose as the original commercial-grade material. For the purpose of this definition, a hazardous secondary mate rial is considered higher-value if it was generated from the use of a commercial-grade material in a manufacturing process and can be remanufactured into a similar commercial-grade material.
260.10
                                 9VAC20-60-18.
              Incorporated by reference (IBR) in 9VAC20-60-260A.
                                       X

            PART 261 IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

                               SUBPART A GENERAL

Add or revise: Reclaimed. Materials noted with a " - " in column 3 of Table 1 are not solid wastes when reclaimed. Materials noted with an "*" in column 3 of Table 1 are solid wastes when reclaimed unless they meet the requirements of §§ 261.4(a)(17), or 261.4(a)(23), 261.4(a)(24), or 261.4(a)(27).
261.2(c)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Revise column 3 to read: Reclamation (§ 261.2(c)(3)), except as provided in §§ 261.4(a)(17), 261.4(a)(23), 261.4(a)(24) or 261.4(a)(27).
261.2(c)(4) table 1
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add section 261.4(a)(27) as follows: Hazardous secondary material that is generated and then transferred to another person for the purpose of remanufacturing is not a solid waste, provided that:
261.4(a)(27) introductory text
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The hazardous secondary material consists of one or more of the following spent solvents: toluene, xylenes, ethylbenzene, 1,2,4-trimethylbenzene, chlorobenzene, n-hexane, cyclohexane, methyl tert-butyl ether, acetonitrile, chloroform, chloromethane, dichloromethane, methyl isobutyl ketone, NN-dimethylformamide, tetrahydrofuran, n-butyl alcohol, ethanol, and/or methanol;
261.4(a)(27)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The hazardous secondary material originated from using one or more of the solvents listed in paragraph (a)(27)(i) of this section in a commercial grade for reacting, extracting, purifying, or blending chemicals (or for rinsing out the process lines associated with these functions) in the pharmaceutical manufacturing (NAICS 325412), basic organic chemical manufacturing (NAICS 325199), plastics and resins manufacturing (NAICS 325211), and/or the paints and coatings manufacturing sectors (NAICS 325510).
261.4(a)(27)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The hazardous secondary material generator sends the hazardous secondary material spent solvents listed in paragraph (a)(27)(i) of this section to a remanufacturer in the pharmaceutical manufacturing (NAICS 325412), basic organic chemical manufacturing (NAICS 325199), plastics and resins manufacturing (NAICS 325211), and/or the paints and coatings manufacturing sectors (NAICS 325510).
261.4(a)(27)(iii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

After remanufacturing one or more of the solvents listed in paragraph (a)(27)(i) of this section, the use of the remanufactured solvent shall be limited to reacting, extracting, purifying, or blending chemicals (or for rinsing out the process lines associated with these functions) in the pharmaceutical manufacturing (NAICS 325412), basic organic chemical manufacturing (NAICS 325199), plastics and resins manufacturing (NAICS 325211), and the paints and coatings manufacturing sectors (NAICS 325510) or to using them as ingredients in a product. These allowed uses correspond to chemical functional uses enumerated under the Chemical Data Reporting Rule of the Toxic Substances Control Act (40 CFR Parts 704, 710 - 711), including Industrial Function Codes U015 (solvents consumed in a reaction to produce other chemicals) and U030 (solvents become part of the mixture);
261.4(a)(27)(iv)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

After remanufacturing one or more of the solvents listed in paragraph (a)(27)(i) of this section, the use of the remanufactured solvent does not involve cleaning or degreasing oil, grease, or similar material from textiles, glassware, metal surfaces, or other articles. (These disallowed continuing uses correspond to chemical functional uses in Industrial Function Code U029 under the Chemical Data Reporting Rule of the Toxics Substances Control Act.); and
261.4(a)(27)(v)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Both the hazardous secondary material generator and the remanufacturer must:
261.4(a)(27)(vi)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Notify EPA or the State Director, if the state is authorized for the program, and update the notification every two years per 40 CFR 260.42;
261.4(a)(27)(vi) (A)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Develop and maintain an up-to-date remanufacturing plan which identifies:
261.4(a)(27)(vi) (B)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The name, address and EPA ID number of the generator(s) and the remanufacturer(s),
261.4(a)(27)(vi)(B) (1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The types and estimated annual volumes of spent solvents to be remanufactured,
261.4(a)(27)(vi)(B) (2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The processes and industry sectors that generate the spent solvents,
261.4(a)(27)(vi)(B) (3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The specific uses and industry sectors for the remanufactured solvents, and
261.4(a)(27)(vi)(B) (4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A certification from the remanufacturer stating "on behalf of [insert remanufacturer facility name], I certify that this facility is a remanufacturer under pharmaceutical manufacturing (NAICS 325412), basic organic chemical manufacturing (NAICS 325199), plastics and resins manufacturing (NAICS 325211), and/or the paints and coatings manufacturing sectors (NAICS 325510), and will accept the spent solvent(s) for the sole purpose of remanufacturing into commercial-grade solvent(s) that will be used for reacting, extracting, purifying, or blending chemicals (or for rinsing out the process lines associated with these functions) or for use as product ingredient(s). I also certify that the remanufacturing equipment, vents, and tanks are equipped with and are operating air emission controls in compliance with the appropriate Clean Air Act regulations under 40 CFR part 60, part 61 or part 63, or, absent such Clean Air Act standards for the particular operation or piece of equipment covered by the remanufacturing exclusion, are in compliance with the appropriate standards in 40 CFR part 261, subparts AA (vents), BB (equipment) and CC (tank storage),";
261.4(a)(27)(vi)(B) (5)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Maintain records of shipments and confirmations of receipts for a period of three years from the dates of the shipments;
261.4(a)(27)(vi)(C)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Prior to remanufacturing, store the hazardous spent solvents in tanks or containers that meet technical standards found in subparts I and J of 40 CFR part 261, with the tanks and containers being labeled or otherwise having an immediately available record of the material being stored;
261.4(a)(27)(vi) (D)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

During remanufacturing, and during storage of the hazardous secondary materials prior to remanufacturing, the remanufacturer certifies that the remanufacturing equipment, vents, and tanks are equipped with and are operating air emission controls in compliance with the appropriate Clean Air Act regulations under 40 CFR part 60, part 61 or part 63; or, absent such Clean Air Act standards for the particular operation or piece of equipment covered by the remanufacturing exclusion, are in compliance with the appropriate standards in 40 CFR part 261 subparts AA (vents), BB (equipment) and CC (tank storage); and
261.4(a)(27)(vi) (E)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Meet the requirements prohibiting speculative accumulation per 40 CFR 261.1(c)(8).
261.4(a)(27)(vi) (F)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

                SUBPART I  -  USE AND MANAGEMENT OF CONTAINERS

Add new Subpart I to Part 261 as follows: Subpart I -- Use and Management of Containers
261 Subpart I
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Applicability
261.170
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

This subpart applies to hazardous secondary materials excluded under the remanufacturing exclusion at § 261.4(a)(27) and stored in containers.
261.170
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Condition of containers.
261.171
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If a container holding hazardous secondary material is not in good condition (e.g., severe rusting, apparent structural defects) or if it begins to leak, the hazardous secondary material must be transferred from this container to a container that is in good condition or managed in some other way that complies with the requirements of this part.
261.171
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Compatibility of hazardous secondary materials with containers.
261.172
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The container must be made of or lined with materials which will not react with, and are otherwise compatible with, the hazardous secondary material to be stored, so that the ability of the container to contain the material is not impaired.
261.172
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Management of containers.
261.173
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A container holding hazardous secondary material must always be closed during storage, except when it is necessary to add or remove the hazardous secondary material.
261.173(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A container holding hazardous secondary material must not be opened, handled, or stored in a manner which may rupture the container or cause it to leak.
261.173(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Containment.
261.175
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Container storage areas must have a containment system that is designed and operated in accordance with paragraph (b) of this section.
261.175(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A containment system must be designed and operated as follows:
261.175(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A base must underlie the containers which is free of cracks or gaps and is sufficiently impervious to contain leaks, spills, and accumulated precipitation until the collected material is detected and removed;
261.175(b)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The base must be sloped or the containment system must be otherwise designed and operated to drain and remove liquids resulting from leaks, spills, or precipitation, unless the containers are elevated or are otherwise protected from contact with accumulated liquids;
261.175(b)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The containment system must have sufficient capacity to contain 10% of the volume of containers or the volume of the largest container, whichever is greater.
261.175(b)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Run-on into the containment system must be prevented unless the collection system has sufficient excess capacity in addition to that required in paragraph (b)(3) of this section to contain any run-on which might enter the system; and
261.175(b)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Spilled or leaked material and accumulated precipitation must be removed from the sump or collection area in as timely a manner as is necessary to prevent overflow of the collection system.
261.175(b)(5)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Special requirements for ignitable or reactive hazardous secondary material.
261.176
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Containers holding ignitable or reactive hazardous secondary material must be located at least 15 meters (50 feet) from the facility's property line.
261.176
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Special requirements for incompatible materials.
261.177
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Incompatible materials must not be placed in the same container.
261.177(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Hazardous secondary material must not be placed in an unwashed container that previously held an incompatible material.
261.177(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A storage container holding a hazardous secondary material that is incompatible with any other materials stored nearby must be separated from the other materials or protected from them by means of a dike, berm, wall, or other device.
261.177(c)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Air emission standards.
261.179
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The remanufacturer or other person that stores or treats the hazardous secondary material shall manage all hazardous secondary material placed in a container in accordance with the applicable requirements of subparts AA, BB, and CC of this part.
261.179
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

                          SUBPART J  -  TANK SYSTEMS

Add new Subpart J to Part 261 as follows: Subpart J -- Tank Systems
261 Subpart J
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Applicability
261.190
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The requirements of this subpart apply to tank systems for storing or treating hazardous secondary material excluded under the remanufacturing exclusion at § 261.4(a)(27).
261.190(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Tank systems, including sumps, as defined in § 260.10, that serve as part of a secondary containment system to collect or contain releases of hazardous secondary materials are exempted from the requirements in § 261.193(a).
261.190(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Assessment of existing tank system's integrity.
261.191
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Tank systems must meet the secondary containment requirements of § 261.193, or the remanufacturer or other person that handles the hazardous secondary material must determine that the tank system is not leaking or is unfit for use. Except as provided in paragraph (c) of this section, a written assessment reviewed and certified by a qualified Professional Engineer must be kept on file at the remanufacturer's facility or other facility that stores or treats the hazardous secondary material that attests to the tank system's integrity.
261.191(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

This assessment must determine that the tank system is adequately designed and has sufficient structural strength and compatibility with the material(s) to be stored or treated, to ensure that it will not collapse, rupture, or fail. At a minimum, this assessment must consider the following:
261.191(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Design standard(s), if available, according to which the tank and ancillary equipment were constructed;
261.191(b)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Hazardous characteristics of the material(s) that have been and will be handled;
261.191(b)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Existing corrosion protection measures;
261.191(b)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Documented age of the tank system, if available (otherwise, an estimate of the age); and
261.191(b)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Results of a leak test, internal inspection, or other tank integrity examination such that:
261.191(b)(5)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

For non-enterable underground tanks, the assessment must include a leak test that is capable of taking into account the effects of temperature variations, tank end deflection, vapor pockets, and high water table effects, and
261.191(b)(5)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

For other than non-enterable underground tanks and for ancillary equipment, this assessment must include either a leak test, as described above, or other integrity examination that is certified by a qualified Professional Engineer that addresses cracks, leaks, corrosion, and erosion.
261.191(b)(5)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The practices described in the American Petroleum Institute (API) Publication, Guide for Inspection of Refinery Equipment, Chapter XIII, "Atmospheric and Low-Pressure Storage Tanks," 4th edition, 1981, may be used, where applicable, as guidelines in conducting other than a leak test.
261.191(b)(5)(ii) Note
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If, as a result of the assessment conducted in accordance with paragraph (a) of this section, a tank system is found to be leaking or unfit for use, the remanufacturer or other person that stores or treats the hazardous secondary material must comply with the requirements of § 261.196.
261.191(c)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.192
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Containment and detection of releases.
261.193
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Secondary containment systems must be:
261.193(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Designed, installed, and operated to prevent any migration of materials or accumulated liquid out of the system to the soil, ground water, or surface water at any time during the use of the tank system; and
261.193(a)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Capable of detecting and collecting releases and accumulated liquids until the collected material is removed.
261.193(a)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If the collected material is a hazardous waste under part 261 of this chapter, it is subject to management as a hazardous waste in accordance with all applicable requirements of parts 262 through 265, 266, and 268 of this chapter. If the collected material is discharged through a point source to waters of the United States, it is subject to the requirements of sections 301, 304, and 402 of the Clean Water Act, as amended. If discharged to a Publicly Owned Treatment Works (POTW), it is subject to the requirements of section 307 of the Clean Water Act, as amended. If the collected material is released to the environment, it may be subject to the reporting requirements of 40 CFR part 302.
261.193(a) Note
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

To meet the requirements of paragraph (a) of this section, secondary containment systems must be at a minimum:
261.193(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Constructed of or lined with materials that are compatible with the materials(s) to be placed in the tank system and must have sufficient strength and thickness to prevent failure owing to pressure gradients (including static head and external hydrological forces), physical contact with the material to which it is exposed, climatic conditions, and the stress of daily operation (including stresses from nearby vehicular traffic).
261.193(b)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Placed on a foundation or base capable of providing support to the secondary containment system, resistance to pressure gradients above and below the system, and capable of preventing failure due to settlement, compression, or uplift;
261.193(b)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Provided with a leak-detection system that is designed and operated so that it will detect the failure of either the primary or secondary containment structure or the presence of any release of hazardous secondary material or accumulated liquid in the secondary containment system at the earliest practicable time; and
261.193(b)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Sloped or otherwise designed or operated to drain and remove liquids resulting from leaks, spills, or precipitation. Spilled or leaked material and accumulated precipitation must be removed from the secondary containment system within 24 hours, or in as timely a manner as is possible to prevent harm to human health and the environment.
261.193(b)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Secondary containment for tanks must include one or more of the following devices:
261.193(c)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A liner (external to the tank);
261.193(c)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A vault; or
261.193(c)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A double-walled tank.
261.193(c)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

In addition to the requirements of paragraphs (a), (b), and (c) of this section, secondary containment systems must satisfy the following requirements:
261.193(d)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

External liner systems must be:
261.193(d)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Designed or operated to contain 100 percent of the capacity of the largest tank within its boundary;
261.193(d)(1)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Designed or operated to prevent run-on or infiltration of precipitation into the secondary containment system unless the collection system has sufficient excess capacity to contain run-on or infiltration. Such additional capacity must be sufficient to contain precipitation from a 25-year, 24-hour rainfall event.
261.193(d)(1)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Free of cracks or gaps; and
261.193(d)(1)(iii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Designed and installed to surround the tank completely and to cover all surrounding earth likely to come into contact with the material if the material is released from the tank(s) (i.e., capable of preventing lateral as well as vertical migration of the material).
261.193(d)(1)(iv)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Vault systems must be:
261.193(d)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Designed or operated to contain 100 percent of the capacity of the largest tank within its boundary;
261.193(d)(2)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Designed or operated to prevent run-on or infiltration of precipitation into the secondary containment system unless the collection system has sufficient excess capacity to contain run-on or infiltration. Such additional capacity must be sufficient to contain precipitation from a 25-year, 24-hour rainfall event;
261.193(d)(2)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Constructed with chemical-resistant water stops in place at all joints (if any);
261.193(d)(2)(iii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Provided with an impermeable interior coating or lining that is compatible with the stored material and that will prevent migration of material into the concrete;
261.193(d)(2)(iv)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Provided with a means to protect against the formation of and ignition of vapors within the vault, if the material being stored or treated is ignitable or reactive; and
261.193(d)(2)(v)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Provided with an exterior moisture barrier or be otherwise designed or operated to prevent migration of moisture into the vault if the vault is subject to hydraulic pressure.
261.193(d)(2)(vi)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Double-walled tanks must be:
261.193(d)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Designed as an integral structure (i.e., an inner tank completely enveloped within an outer shell) so that any release from the inner tank is contained by the outer shell;
261.193(d)(3)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Protected, if constructed of metal, from both corrosion of the primary tank interior and of the external surface of the outer shell; and
261.193(d)(3)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Provided with a built-in continuous leak detection system capable of detecting a release within 24 hours, or at the earliest practicable time.
261.193(d)(3)(iii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The provisions outlined in the Steel Tank Institute's (STI) "Standard for Dual Wall Underground Steel Storage Tanks" may be used as guidelines for aspects of the design of underground steel double-walled tanks.
261.193(d)(3)Note
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.193(e)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Ancillary equipment must be provided with secondary containment (e.g., trench, jacketing, double-walled piping) that meets the requirements of paragraphs (a) and (b) of this section except for:
261.193(f)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Aboveground piping (exclusive of flanges, joints, valves, and other connections) that are visually inspected for leaks on a daily basis;
261.193(f)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Welded flanges, welded joints, and welded connections that are visually inspected for leaks on a daily basis;
261.193(f)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Sealless or magnetic coupling pumps and sealless valves that are visually inspected for leaks on a daily basis; and
261.193(f)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Pressurized aboveground piping systems with automatic shut-off devices (e.g., excess flow check valves, flow metering shutdown devices, loss of pressure actuated shut-off devices) that are visually inspected for leaks on a daily basis.
261.193(f)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: General operating requirements.
261.194
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Hazardous secondary materials or treatment reagents must not be placed in a tank system if they could cause the tank, its ancillary equipment, or the containment system to rupture, leak, corrode, or otherwise fail.
261.194(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The remanufacturer or other person that stores or treats the hazardous secondary material must use appropriate controls and practices to prevent spills and overflows from tank or containment systems. These include at a minimum:
261.194(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Spill prevention controls (e.g., check valves, dry disconnect couplings);
261.194(b)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Overfill prevention controls (e.g., level sensing devices, high level alarms, automatic feed cutoff, or bypass to a standby tank); and
261.194(b)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Maintenance of sufficient freeboard in uncovered tanks to prevent overtopping by wave or wind action or by precipitation.
261.194(b)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The remanufacturer or other person that stores or treats the hazardous secondary material must comply with the requirements of § 261.196 of this subpart if a leak or spill occurs in the tank system.
261.194(c)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.195
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Response to leaks or spills and disposition of leaking or unfit-for-use tank systems.
261.196
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add introductory text to read as follows: A tank system or secondary containment system from which there has been a leak or spill, or which is unfit for use, must be removed from service immediately, and the remanufacturer or other person that stores or treats the hazardous secondary material must satisfy the following requirements:
261.196
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Cessation of use; prevent flow or addition of materials. The remanufacturer or other person that stores or treats the hazardous secondary material must immediately stop the flow of hazardous secondary material into the tank system or secondary containment system and inspect the system to determine the cause of the release.
261.196(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Removal of material from tank system or secondary containment system.
261.196(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If the release was from the tank system, the remanufacturer or other person that stores or treats the hazardous secondary material must, within 24 hours after detection of the leak or, if the remanufacturer or other person that stores or treats the hazardous secondary material demonstrates that it is not possible, at the earliest practicable time, remove as much of the material as is necessary to prevent further release of hazardous secondary material to the environment and to allow inspection and repair of the tank system to be performed.
261.196(b)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If the material released was to a secondary containment system, all released materials must be removed within 24 hours or in as timely a manner as is possible to prevent harm to human health and the environment.
261.196(b)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Containment of visible releases to the environment. The remanufacturer or other person that stores or treats the hazardous secondary material must immediately conduct a visual inspection of the release and, based upon that inspection:
261.196(c)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Prevent further migration of the leak or spill to soils or surface water; and
261.196(c)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Remove, and properly dispose of, any visible contamination of the soil or surface water.
261.196(c)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Notifications, reports.
261.196(d)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Any release to the environment, except as provided in paragraph (d)(2) of this section, must be reported to the Regional Administrator within 24 hours of its detection. If the release has been reported pursuant to 40 CFR part 302, that report will satisfy this requirement.
261.196(d)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

A leak or spill of hazardous secondary material is exempted from the requirements of this paragraph if it is:
261.196(d)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Less than or equal to a quantity of 1 pound, and
261.196(d)(2)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Immediately contained and cleaned up.
261.196(d)(2)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Within 30 days of detection of a release to the environment, a report containing the following information must be submitted to the Regional Administrator:
261.196(d)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Likely route of migration of the release;
261.196(d)(3)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Characteristics of the surrounding soil (soil composition, geology, hydrogeology, climate);
261.196(d)(3)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Results of any monitoring or sampling conducted in connection with the release (if available). If sampling or monitoring data relating to the release are not available within 30 days, these data must be submitted to the Regional Administrator as soon as they become available.
261.196(d)(3)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Proximity to downgradient drinking water, surface water, and populated areas; and
261.196(d)(3)(iv)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Description of response actions taken or planned.
261.196(d)(3)(v)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Provision of secondary containment, repair, or closure.
261.196(e)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Unless the remanufacturer or other person that stores or treats the hazardous secondary material satisfies the requirements of paragraphs (e)(2) through (4) of this section, the tank system must cease to operate under the remanufacturing exclusion at 40 CFR 261.4(a)(27).
261.196(e)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If the cause of the release was a spill that has not damaged the integrity of the system, the remanufacturer or other person that stores or treats the hazardous secondary material may return the system to service as soon as the released material is removed and repairs, if necessary, are made.
261.196(e)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If the cause of the release was a leak from the primary tank system into the secondary containment system, the system must be repaired prior to returning the tank system to service.
261.196(e)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

If the source of the release was a leak to the environment from a component of a tank system without secondary containment, the remanufacturer or other person that stores or treats the hazardous secondary material must provide the component of the system from which the leak occurred with secondary containment that satisfies the requirements of § 261.193 before it can be returned to service, unless the source of the leak is an aboveground portion of a tank system that can be inspected visually. If the source is an aboveground component that can be inspected visually, the component must be repaired and may be returned to service without secondary containment as long as the requirements of paragraph (f) of this section are satisfied. Additionally, if a leak has occurred in any portion of a tank system component that is not readily accessible for visual inspection (e.g., the bottom of an inground or onground tank), the entire component must be provided with secondary containment in accordance with § 261.193 of this subpart prior to being returned to use.
261.196(e)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Certification of major repairs. If the remanufacturer or other person that stores or treats the hazardous secondary material has repaired a tank system in accordance with paragraph (e) of this section, and the repair has been extensive ( e.g., installation of an internal liner; repair of a ruptured primary containment or secondary containment vessel), the tank system must not be returned to service unless the remanufacturer or other person that stores or treats the hazardous secondary material has obtained a certification by a qualified Professional Engineer that the repaired system is capable of handling hazardous secondary materials without release for the intended life of the system. This certification must be kept on file at the facility and maintained until closure of the facility.
261.196(f)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The Regional Administrator may, on the basis of any information received that there is or has been a release of hazardous secondary material or hazardous constituents into the environment, issue an order under RCRA section 7003(a) requiring corrective action or such other response as deemed necessary to protect human health or the environment.
261.196 Note 1
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

40 CFR part 302 may require the owner or operator to notify the National Response Center of certain releases.
261.196 Note 2
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Termination of remanufacturing exclusion.
261.197
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Hazardous secondary material stored in units more than 90 days after the unit ceases to operate under the remanufacturing exclusion at 40 CFR 261.4(a)(27) or otherwise ceases to be operated for manufacturing, or for storage of a product or a raw material, then becomes subject to regulation as hazardous waste under parts 261 through 266, 268, 270, 271, and 124 of this chapter, as applicable.
261.197
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Special requirements for ignitable or reactive materials.
261.198
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Ignitable or reactive material must not be placed in tank systems, unless the material is stored or treated in such a way that it is protected from any material or conditions that may cause the material to ignite or react.
261.198(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The remanufacturer or other person that stores or treats hazardous secondary material which is ignitable or reactive must store or treat the hazardous secondary material in a tank that is in compliance with the requirements for the maintenance of protective distances between the material management area and any public ways, streets, alleys, or an adjoining property line that can be built upon as required in Tables 2 - 1 through 2 - 6 of the National Fire Protection Association's "Flammable and Combustible Liquids Code," (1977 or 1981), (incorporated by reference, see § 260.11).
261.198(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Special requirements for incompatible materials.
261.199
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Incompatible materials must not be placed in the same tank system.
261.199(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Hazardous secondary material must not be placed in a tank system that has not been decontaminated and that previously held an incompatible material.
261.199(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Air emission standards.
261.200
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The remanufacturer or other person that stores or treats the hazardous secondary material shall manage all hazardous secondary material placed in a tank in accordance with the applicable requirements of subparts AA, BB, and CC of this part.
261.200
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

            SUBPART AA  -  AIR EMISSION STANDARDS FOR PROCESS VENTS

Add new Subpart AA to Part 261 as follows: Subpart AA -- Air Emission Standards for Process Vents
261 Subpart AA
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Applicability
261.1030
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The regulations in this subpart apply to process vents associated with distillation, fractionation, thin-film evaporation, solvent extraction, or air or stream stripping operations that manage hazardous secondary materials excluded under the remanufacturing exclusion at § 261.4(a)(27) with concentrations of at least 10 ppmw, unless the process vents are equipped with operating air emission controls in accordance with the requirements of an applicable Clean Air Act regulation codified under 40 CFR part 60, part 61, or part 63.
261.1030
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Definitions. As used in this subpart, all terms not defined herein shall have the meaning given them in the Resource Conservation and Recovery Act and parts 260 - 266.
261.1031
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.1033(b)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

           SUBPART BB  -  AIR EMISSION STANDARDS FOR EQUIPMENT LEAKS

Add new Subpart BB to Part 261 as follows: Subpart BB -- Air Emission Standards for Equipment Leaks
261 Subpart BB
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Applicability
261.1050
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The regulations in this subpart apply to equipment that contains hazardous secondary materials excluded under the remanufacturing exclusion at § 261.4(a)(27), unless the equipment operations are subject to the requirements of an applicable Clean Air Act regulation codified under 40 CFR part 60, part 61, or part 63.
261.1050(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Definitions. As used in this subpart, all terms shall have the meaning given them in § 261.1031, the Resource Conservation and Recovery Act, and 40 CFR parts 260 - 266.
261.1051
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

        SUBPART CC  -  AIR EMISSION STANDARDS FOR TANKS AND CONTAINERS

Add new Subpart CC to Part 261 as follows: Subpart CC -- Air Emission Standards for Tanks and Containers
Subpart CC
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Add Heading: Applicability
261.1080
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The regulations in this subpart apply to tanks and containers that contain hazardous secondary materials excluded under the remanufacturing exclusion at § 261.4(a)(27), unless the tanks and containers are equipped with and operating air emission controls in accordance with the requirements of an applicable Clean Air Act regulations codified under 40 CFR part 60, part 61, or part 63.
261.1080(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.1080(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Definitions. As used in this subpart, all terms not defined herein shall have the meaning given to them in the Resource Conservation and Recovery Act and parts 260 through 266 of this chapter.
261.1081
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

The remanufacturer or other person that stores or treats the hazardous secondary material shall control air pollutant emissions from each hazardous secondary material management unit in accordance with standards specified in §§ 261.1084 through 261.1087 of this subpart, as applicable to the hazardous secondary material management unit, except as provided for in paragraph (c) of this section.
261.1082(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.1083(b)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.1086(b)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.1089(c)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

Reserved
261.1089(f)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

No corresponding provisions
261.1089(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X

No corresponding provisions
261.1089(j)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-261A.
                                       X


[Federal Register Volume 88, Number 199 (Tuesday, October 17, 2023)]
[Notices]
[Page 71578]
[FR Doc No: 2023-22844]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-3682]

Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating
Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined that ZOFRAN ODT (ondansetron) orally disintegrating tablets,
4 milligrams (mg) and 8 mg, were not withdrawn from sale for reasons of
safety or effectiveness. This determination means that FDA will not
begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Veniqua Stewart, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3267, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8
mg, are the subject of NDA 020781, held by Sandoz Inc., and initially
approved on January 27, 1999. ZOFRAN ODT is indicated for the
prevention of nausea and vomiting associated with: highly emetogenic
cancer chemotherapy, including cisplatin greater than or equal to 50
mg/m\2\; initial and repeat courses of moderately emetogenic cancer
chemotherapy; and radiotherapy in patients receiving either total body
irradiation, single high-dose fraction to the abdomen, or daily
fractions to the abdomen. ZOFRAN ODT is also indicated for the
prevention of postoperative nausea and/or vomiting.
    ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8
mg, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
    Sun Pharmaceutical Industries Limited submitted a citizen petition
dated August 24, 2023 (Docket No. FDA-2023-P-3682), under 21 CFR 10.30,
requesting that the Agency determine whether ZOFRAN ODT (ondansetron)
orally disintegrating tablets, 4 mg and 8 mg, were withdrawn from sale
for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ZOFRAN ODT (ondansetron) orally disintegrating
tablets, 4 mg and 8 mg, were not withdrawn from sale for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that ZOFRAN ODT (ondansetron) orally
disintegrating tablets, 4 mg and 8 mg, were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ZOFRAN ODT (ondansetron) orally
disintegrating tablets, 4 mg and 8 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that these drug products were not withdrawn from sale
for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ZOFRAN ODT
(ondansetron) orally disintegrating tablets, 4 mg and 8 mg, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to these drug products.
Additional ANDAs for these drug products may also be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for these
drug products should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.

    Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22844 Filed 10-16-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Rules and Regulations]
[Pages 68970-68972]
[FR Doc No: 2010-28388]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2010-1071; Airspace Docket No. 10-ASO-28]
RIN 2120-AA66

Amendment of Using Agency for Restricted Areas R-5301; R-5302A,
B, and C; and R-5313A, B, C and D; NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This action makes a minor change to the name of the using
agency for restricted areas R-5301 Albemarle Sound, NC; R-5302A, B and
C, Harvey Point, NC; and R-5313A, B, C and D, Long Shoal Point, NC to
read ``U.S. Navy, Fleet Area Control and Surveillance Facility,
Virginia Capes (FACSFAC VACAPES), Virginia Beach, VA.'' This is an
administrative change only and there are no changes to the

dimensions, time of designation or activities conducted within the
affected restricted areas.

DATES: Effective date 0901 UTC, January 13, 2011.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Systems, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The U.S. Navy requested a minor change to the name of the using
agency for restricted areas R-5301; R-5302A, B and C; and R-5313A, B, C
and D, in North Carolina by removing the words ``NAS Oceana'' from the
description in order to reflect the organization's current designation.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 73 by changing the using agency names for restricted area R-5301
Albemarle Sound, NC; restricted areas R-5302A, B and C, Harvey Point,
NC; and restricted areas R-5313A, B, C and D, Long Shoal Point, NC from
``U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia
Capes (FACSFAC VACAPES), NAS Oceana, Virginia Beach, VA,'' to ``U.S.
Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''. This is an administrative
change and does not affect the boundaries, designated altitudes, or
activities conducted within the restricted area; therefore, notice and
public procedures under 5 U.S.C. 553(b) are unnecessary.
    The FAA has determined that this action only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with 311d., FAA Order 1050.1E, Environmental Impacts: Policies and
Procedures. This airspace action is an administrative change to the
descriptions of the affected restricted areas to update the using
agency name. It does not alter the dimensions, altitudes, or times of
designation of the airspace; therefore, it is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 73, as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  73.53  [Amended]

0
2. Sec.  73.53 is amended as follows:
* * * * *

1. R-5301 Albemarle Sound, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control
and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''

2. R-5302A Harvey Point, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control
and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''

3. R-5302B Harvey Point, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control
and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''

4. R-5302C Harvey Point, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control
and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''

5. R-5313A Long Shoal Point, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control
and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''

6. R-5313B Long Shoal Point, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control
and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''

7. R-5313C Long Shoal Point, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control
and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''

8. R-5313D Long Shoal Point, NC [Amended]

    By removing the words ``Using agency. U.S. Navy, Fleet Area Control

and Surveillance Facility, Virginia Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA'' and inserting the words ``Using agency.
U.S. Navy, Fleet Area Control and Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach, VA.''
* * * * *

    Issued in Washington, DC, on November 4, 2010.
Edith V. Parish,
Manager, Airspace, Regulations and ATC Procedures Group.
[FR Doc. 2010-28388 Filed 11-9-10; 8:45 am]
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[Federal Register: December 10, 2007 (Volume 72, Number 236)]
[Proposed Rules]
[Page 69628-69630]
[DOCID:fr10de07-28]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0299; Directorate Identifier 2007-NM-239-AD]
RIN 2120-AA64

Airworthiness Directives; Saab Model SAAB 2000 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, the FAA has published Special Federal
Aviation Regulation 88 (SFAR88) * * * [which] required * * *
[conducting] a design review against explosion risks.

The unsafe condition is the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane. The
proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by January 9, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-0299;
Directorate Identifier 2007-NM-239-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2007-0167, dated June 15, 2007 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, the FAA has published Special Federal
Aviation Regulation 88 (SFAR88) in June 2001.
    In their Letters referenced 04/00/02/07/01-L296 dated March 4th,
2002 and 04/00/02/07/03-L024, dated February 3rd, 2003, the JAA
(Joint Aviation Authorities) recommended the application of a
similar regulation to the National Aviation Authorities (NAA).
    Under this regulation, all holders of type certificates for
passenger transport aircraft with either a passenger capacity of 30
or more, or a payload capacity of 7,500 pounds (3402 kg) or more,
which have received their certification since January 1st, 1958, are
required to conduct a design review against explosion risks.
    This Airworthiness Directive (AD), which renders mandatory the
modification [6089] of improving the sealing of Fuel Access Doors,
is a consequence of the design review.
    The unsafe condition is the potential of ignition sources inside
fuel tanks, which, in combination with flammable fuel vapors, could
result in fuel tank explosions and consequent loss of the airplane.
Saab Modification 6089 includes removing the fuel tank access doors and
the old type of clamp rings and gaskets; installing new, improved

clamp rings; re-installing the fuel tank access doors; and doing
related investigative actions and applicable corrective actions.
Related investigative actions and applicable corrective actions include
inspecting for corrosion of the wing skin panel and access door areas,
and, as applicable, replacing wear protection; contacting Saab and
doing repairs if doubler flange is less than specified thickness;
replacing any corroded or damaged foil panel; replacing any damaged
sealing ring; removing corrosion from the wing skin panel; inspecting
the access doors for damage and correct installation of the aluminum
panel on the access door; and, as applicable, replacing the aluminum
panel or the entire access door. You may obtain further information by
examining the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88. (The JAA is an associated body of the European
Civil Aviation Conference (ECAC) representing the civil aviation
regulatory authorities of a number of European States who have agreed
to co-operate in developing and implementing common safety regulatory
standards and procedures.) Under this regulation, the JAA stated that
all members of the ECAC that hold type certificates for transport
category airplanes are required to conduct a design review against
explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Saab has issued Service Bulletins 2000-57-033, dated March 2, 2000,
and Revision 01, dated March 31, 2000. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 6 products of U.S. registry. We also estimate that
it would take about 130 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Required parts would cost about $6,400 per product. Where
the service information lists required parts costs that are covered
under warranty, we have assumed that there will be no charge for these
costs. As we do not control warranty coverage for affected parties,
some parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $100,800, or $16,800 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Saab Aircraft AB: Docket No. FAA-2007-0299; Directorate Identifier
2007-NM-239-AD.

Comments Due Date

    (a) We must receive comments by January 9, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Saab Model SAAB 2000 airplanes, all
serial numbers, certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on ground, the FAA has published Special Federal
Aviation Regulation 88 (SFAR88) in June 2001.
    In their Letters referenced 04/00/02/07/01-L296 dated March 4th,
2002 and 04/00/02/07/03-L024, dated February 3rd, 2003, the JAA
(Joint Aviation Authorities) recommended the application of a
similar regulation to the National Aviation Authorities (NAA).
    Under this regulation, all holders of type certificates for
passenger transport aircraft with either a passenger capacity of 30
or more, or a payload capacity of 7,500 pounds (3402 kg) or more,
which have received their certification since January 1st, 1958, are
required to conduct a design review against explosion risks.
    This Airworthiness Directive (AD), which renders mandatory the
modification [6089] of improving the sealing of Fuel Access Doors,
is a consequence of the design review.

The unsafe condition is the potential of ignition sources inside
fuel tanks, which, in combination with flammable fuel vapors, could
result in fuel tank explosions and consequent loss of the airplane.

Actions and Compliance

    (f) Within 48 months after the effective date of this AD, unless
already done, do Modification 6089 and all related investigative
actions and applicable corrective actions, in accordance with the
Accomplishment Instructions of Saab Service Bulletin 2000-57-033,
dated March 2, 2000; or Revision 01, dated March 31, 2000. Do all
applicable related investigative and corrective actions before
further flight.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-
116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
227-1149. Before using any approved AMOC on any airplane to which
the AMOC applies, notify your appropriate principal inspector (PI)
in the FAA Flight Standards District Office (FSDO), or lacking a PI,
your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI EASA Airworthiness Directive 2007-0167, dated
June 15, 2007; Saab Service Bulletin 2000-57-033, dated March 2,
2000; and Saab Service Bulletin 2000-57-033, Revision 01, dated
March 31, 2000; for related information.

    Issued in Renton, Washington, on November 30, 2007.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. E7-23869 Filed 12-7-07; 8:45 am]

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