(a) Revisions to the plan identified in §52.2570 were submitted on the date specified. (1)-(3) [Reserved] (4) On November 15, 1993, and July 28, 1994, the Wisconsin Department of Natural Resources (WDNR) submitted enhanced inspection and maintenance (I/M) rules and a Request for Proposal (RFP) as a

As used in this subpart, all terms not defined herein shall have the meaning given them in the Act and in subpart A of this part. (a) Superphosphoric acid plant means any facility that concentrates wet-process phosphoric acid to 66 percent or greater P2O5 content by weight for eventual

(a) (1) To determine compliance with the standards for sulfur dioxide specified in §60.642(a), during the initial performance test as required by §60.8, the minimum required sulfur dioxide emission reduction efficiency (Z) is compared to the

(a) If all qualified operators are not accessible for 2 weeks or more, you must take the two actions in paragraphs (a)(1) and (2) of this section: (1) Submit a notification of the deviation within 10 days that includes the three items in paragraphs (a)(1)(i) through (iii) of this section: (i) A statement of what caused the deviation; (ii) A description of what

months, and the fuel(s) or non-waste materials the unit will commence combusting; (4) The date on which you became subject to the currently applicable emission limits; and (5) The date upon which you will cease combusting solid waste, and the date (if different) that you intend for any new requirements to become applicable (i.e., the effective date of the waste-to-fuel switch), consistent with

(a) If all qualified operators are not accessible for 2 weeks or more, you must take the two actions in paragraphs (a)(1) and (2) of this section: (1) Submit a notification of the deviation within 10 days that includes the three items in paragraphs (a)(1)(i) through (iii) of this section: (i) A statement of what caused the deviation; (ii) A description of what

(a) If all qualified operators are not accessible for 2 weeks or more, you must take the two actions in paragraphs (a)(1) and (2) of this section. (1) Submit a notification of the deviation within 10 days that includes the three items in paragraphs (a)(1)(i) through (iii) of this section. (i) A statement of what caused the deviation. (ii) A description of what

(a) If all qualified operators are not accessible for 2 weeks or more, you must take the two actions in paragraphs (a)(1) and (2) of this section. (1) Submit a notification of the deviation within 10 days that includes the three items in paragraphs (a)(1)(i) through (iii) of this section. (i) A statement of what caused the deviation. (ii) A description of what

reconstruction after promulgation of the final 40 CFR part 60 subpart CCCC (New Source Performance Standards for Commercial and Industrial Solid Waste Incineration Units), your CISWI unit is subject to subpart CCCC of 40 CFR part 60 and this subpart no longer applies to that unit. (c) If you make physical or operational changes to your existing CISWI unit primarily to comply with this subpart, then such changes do not qualify as modifications or reconstructions under subpart

(a) If all qualified operators are not accessible for two weeks or more, you must take the two actions in paragraphs (a)(1) and (2) of this section. (1) Within 10 days of each deviation, you must submit a notification that includes the three items in paragraphs (a)(1)(i) through (iii) of this section. (i) A statement of what caused the deviation. (ii) A

arc furnace; (2) Casting operations; (3) Metal oxygen refining (MOR) process; (4) Crushing and screening operations; (5) Outdoor fugitive dust sources. (c) A new affected source is any of the equipment listed in paragraph (b) of this section for which construction or reconstruction commenced after June 30, 2015.

instrumentation systems; and control devices. (c) Your affected source is a new affected source if you commence construction of the affected source after May 8, 2002, and you meet the applicability criteria in §63.7181 at the time you commence construction. (d) Your affected source is a reconstructed affected source if you meet the criteria for

this part. Such notice, if given, shall include a copy of the final order issued under §58.206(a) and shall state that the disqualification constitutes a determination by the Food and Drug Administration that nonclinical laboratory studies performed by the facility will not be considered by the Food and Drug Administration in support of any application for a research or marketing permit. If such

Labeling. The label of the color additives shall conform to the requirements of §70.25 of this chapter. (d) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health and, therefore, the color additives are exempt from the certification requirements of

which the additive is used. (c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health

. The label of the color additive shall conform to the requirements in §70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the

not exceed by more than 0.3 percent the fat content of the cleaned corn from which it was ground. The contents of crude fiber and fat in all the foregoing provisions relating thereto are on a moisture-free basis. (b) For the purposes of this section, moisture, fat and crude fiber are determined by the methods therefor referred to in §137.250(b)(1).

seasoning in curing premixes, may continue to be used under prior sanctions in the commercial curing of meat and meat products and poultry products and in accordance with the provisions of §§172.170 and 172.175 of this chapter that apply to meat curing preparations for the home curing of meat and meat products, including poultry and wild game. To assure safe use of such ingredients the labeling of the

organisms/gram by aerobic plate count. (2) Less than 10 yeasts and molds/gram. (3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clostridium perfringens, Clostridium botulinum, or any other recognized microbial pathogen or any harmful microbial toxin. (d) The ingredient is used in food as a nutrient

Saponification number 75 to 120. (b) It is used or intended for use as follows: Open Table Food Limitation

and 600.3(t) of this chapter. Solid oral dosage form means capsules, tablets, or similar drug products intended for oral use.

determine the need for an investigation, conduct investigations when necessary, and take appropriate corrective actions. (e) Quality assurance. You must establish and follow written quality assurance procedures.

), records concerning shipment, delivery, receipt, and disposition of the drug, which are required to be kept under this part or other applicable parts of this chapter shall, upon the request of a properly authorized employee of the Drug Enforcement Administration of the U.S. Department of Justice, be made available by the investigator or sponsor to whom the request is made, for inspection and copying. In addition, the sponsor shall assure that adequate precautions are taken, including storage of the

(a) Scope. This subpart contains the requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy (REMS) when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The aim of this subpart is to facilitate the availability of such drugs to patients with serious diseases or conditions when there is no comparable

a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by §1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information

has the authority to establish or continue in effect any requirement having the force and effect of law with respect to a device intended for human use. (e) State means a State, American Samoa, the Canal Zone, the Commonwealth of Puerto Rico, the District of Columbia, Guam, Johnston Island, Kingman Reef, Midway Island, the Trust Territory of the Pacific Islands, the Virgin Islands, and Wake Island.

(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements. (b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with §820.100.

(a) Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal

(a) Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must assess the following electrical output specifications

(1) The amount of the quarterly assessment imposed on the domestic manufacturer or importer and the date that payment of the assessment must be received by FDA; (2) Class assessment information, including each class' initial percentage share, the reallocation amount (if any) and each class' percentage share after any such reallocation, and the quarterly assessment for each class; (3) Domestic manufacturer