The information collection requirements contained in part 777 have been approved by the Office of Management and Budget under 44 U.S.C. 3507 and assigned clearance number 1029-0032. The information is being collected to meet the requirements of sections 507, 508, and 510(b) of the Act. It provides general requirements for permit application format and contents. The obligation to respond is

(a) The U.S. Soil Conservation Service within each State shall establish specifications for prime farmland soil removal, storage, replacement, and reconstruction. (b) The regulatory authority within each State shall use the soil-reconstruction specifications of paragraph (a) of this section to carry out its responsibilities under §785.17

You must place oil in marketable condition and market the oil for the mutual benefit of the lessee and the lessor at no cost to the Federal Government. If you use gross proceeds under an arm's-length contract in determining value, you must increase those gross proceeds to the extent that the purchaser, or any other person, provides certain services that the seller normally would be responsible to perform to place the oil in marketable condition or to market the oil.

The presiding officer may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief. The presiding officer shall fix the time for filing such briefs, not to exceed 60 days from the date the parties receive the transcript of the hearing or, if applicable, the stipulated record. Such briefs may be accompanied by proposed findings of fact and conclusions of law. The presiding officer may permit the parties to file responsive briefs.

This section and §§49.10702 through 49.10730 contain the implementation plan for the Shoshone-Bannock Tribes of the Fort Hall Indian Reservation. This plan consists of a combination of Tribal rules and measures and Federal regulations and measures which apply within the Fort Hall Indian Reservation. [70 FR 18125, Apr. 8

(a) The requirements of section 169A of the Clean Air Act are not met, because the plan does not include approvable procedures for protection of visibility in mandatory Class I Federal areas. (b)-(c) [Reserved] [50 FR 28553, July 12, 1985; 51 FR 23759, July 1, 1986, as amended at 52 FR 45137, Nov. 24, 1987; 82 FR 3129, Jan. 10, 2017]

The provisions in this subpart do not preclude any State or any political subdivision of a State from: (a) Adopting and enforcing any emission standard or limitation applicable to anyone subject to the provisions of this part; or (b) Requiring the regulated entity to obtain permits, licenses, or approvals prior to initiating construction, modification, or operation of a facility for manufacturing a

(a) Include an analysis of how your municipal waste combustion unit affects four areas: (1) Ambient air quality. (2) Visibility. (3) Soils. (4) Vegetation. (b) Include an analysis of alternatives for controlling air pollution that minimize potential risks to the public health and the environment

An owner or operator may submit to the Administrator a written application for a determination of whether actions intended to be taken by the owner or operator constitute construction or modification, or commencement thereof, of a source subject to a standard. The Administrator will notify the owner or operator of his determination within 30 days after receiving sufficient information to evaluate the application. [50 FR

Letter from the Virgin Islands Department of Planning and Natural Resources submitted April 04, 2017 to Acting Regional Administrator Catherine R. Mc Cabe, certifying that the United States Virgin Islands has no existing unites pursuant to 40 CFR 60 Subpart FFFF, Emissions Guidelines and Compliaince Times for Other Solid Waste Incineration Units that commenced construction on or before December 9, 2004. [82 FR 43309

Not necessarily. Sources subject to this subpart include, but are not limited to, the inventory of sources listed in Docket ID Number EPA-HQ-OAR-2011-0405 for the federal plan. Review the applicability of §62.14400 to determine if you are subject to this subpart. [78 FR 28066, May 13, 2013]

The provisions of this subpart apply to an owner or operator of an existing source who wishes to obtain a compliance extension from a standard issued under section 112(d) of the Act. The provisions of this subpart also apply to a State or local agency acting pursuant to a permit program approved under title V of the Act. The Administrator will carry out the provisions of this subpart for any State that does not have an approved permit program.

To demonstrate continuing compliance with §63.402 of this subpart, the owner or operator of each affected IPCT shall maintain copies of the initial notification and the notification of compliance status as required by §63.405 of this subpart for a period of at least 5 years onsite.

(a) Table 10 to this subpart shows which provisions of the General Provisions in §§63.1 through 63.15 apply to you. (b) For the purposes of this subpart, the applicable subpart A requirements in Table 10 to this subpart supersede the applicable subpart A requirements in subparts F, G, H, U and UU of this part.

You must conduct the initial compliance demonstrations that apply to you in Table 3 to this subpart within 180 calendar days after the compliance date that is specified for your new or reconstructed affected source in §63.9295 and according to the provisions in §63.7(a)(2).

You must keep the records specified in paragraphs (a) and (b) of this section. (a) A copy of the Initial Notification of Compliance Status that you submitted to comply with this subpart. (b) Records required by §63.10420 for each sterilization unit not equipped with an air pollution control device.

(a) This part applies to all proceedings for the assessment by EPA of a noncompliance penalty as provided by section 120 of the Clean Air Act. This penalty is designed to recover the economic advantage which might otherwise accrue to a source by reason of its failure to comply with air pollution control standards after receipt of a notice of noncompliance. (b) These regulations shall be effective October 27, 1980.

The procedures in this part apply when— (a) A person has a right to an opportunity for a hearing under the laws specified in §10.50; or (b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part. (b) You must establish and keep documentation of the date and method of cleaning and sanitizing of equipment subject to this subpart used in: (1) Growing operations for sprouts; and (2) Covered harvesting, packing, or holding activities.

In order to meet the requirements of subpart A of this part, processors of smoked and smoke-flavored fishery products, except those subject to the requirements of part 113 or 114 of this chapter, shall include in their HACCP plans how they are controlling the food safety hazard associated with the formation of toxin by Clostridium botulinum for at least as long as the shelf life of the product under normal and moderate abuse conditions.

(a) Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. (b) A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling. (c) Results of these examinations shall be recorded in the batch production or control

This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy). [57 FR 58958, Dec. 11, 1992, as amended

The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in §336.50(d): (a) Cyclizine hydrochloride. (b) Dimenhydrinate. (c) Diphenhydramine hydrochloride. (d

As used in this part: Analgesic—antipyretic drug. An agent used to alleviate pain and to reduce fever. Cardiovascular drug. An agent used to prevent ischemic events. Rheumatologic drug. An agent used for the

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient. (a) Ephedrine sulfate 0.1 to 1.25 percent. (b) Epinephrine 0.005 to 0.01 percent. (c) Epinephrine hydrochloride 0.005 to 0.01 percent. (d) Phenylephrine hydrochloride 0.25

The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each ingredient. (a) Salicylic acid 12 to 40 percent in a plaster vehicle. (b) Salicylic acid 5 to 17 percent in a collodion-like vehicle. (c) Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle.

The transcript and record shall be certified by the Commissioner of Food and Drugs (the Commissioner). In any case in which the Commissioner enters an order without a hearing under §314.200(g) of this chapter, the request(s) for hearing together with the data and information submitted and the Commissioner's findings and conclusions shall be included in the record certified by the Commissioner

(a) In accordance with §530.22, the following safe levels for extralabel use of an approved animal drug or human drug have been established: [Reserved] (b) In accordance with §530.22, the following analytical methods have been accepted by

(a) Identification. An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease. (b)

(a) Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger. (b) Classification. Class II