. Copies of all supporting materials shall accompany the notice if requested, or shall be placed on file in the appropriate Regional Office and made available for inspection during normal business hours. The State shall have 90 days in which to respond in writing to this determination. If the Administrator finds after reviewing the State response that (a) the State is in fact administering the program in conformity with

of the nozzle and hose. After January 1, 2000 this requirement applies to every natural gas retailer and wholesale purchaser-consumer. Any dispensing pump shown to be dedicated to heavy-duty vehicles is exempt from this requirement. (b) The provisions of paragraph (a) of this section can be waived for refueling stations which were in operation on or before January 1, 1998 provided the station operator can demonstrate, to the satisfaction of the Administrator, that

participant may file a brief in opposition, within the period allowed by the entity deciding the appeal (currently the DAB). The deadline for filing an interlocutory appeal is subject to the discretion of the presiding officer.

the Federal Food, Drug, and Cosmetic Act in that the food has been grown, harvested, packed, or held under such conditions that it is unfit for food; or (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or

(a) An FDA Division Director in whose division the farm is located (or, in the case of a foreign farm, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition), or an FDA official senior to either such Director, must approve an order to withdraw the exemption before the order is issued. (b) Any officer or qualified employee of FDA may issue an order to withdraw the exemption after it has been

(a) An FDA Division Director in whose division the qualified facility is located (or, in the case of a foreign facility, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition), or an FDA official senior to either such Director, must approve an order to withdraw the exemption before the order is issued. (b) Any officer or qualified employee of FDA may issue an order to withdraw the exemption after

500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. (a) Shell content—12th ed. (1975), methods 13.010-13.014, under the heading “Shell in Cacao Nibs—Official Final Action,” pp. 208-210.

paperboard excluding that which (i) bears or contains any poisonous or deleterious substance which is retained in the recovered pulp and that migrates to the food, except as provided in regulations promulgated under sections 406 and 409 of the act or (ii) has been used for shipping or handling any such substance.

Certain other spices, seasonings, essential oils, oleoresins, and natural extracts that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Open Table Common name

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 44876, Nov. 7, 1988, as amended at 73 FR 8608, Feb. 14, 2008]

regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to

The product consists of any of the following active ingredients within the specified concentration established for each ingredient and in the specified dosage form: (a) Bacitracin ointment containing, in each gram, 500 units of bacitracin in a suitable ointment base. (b) Bacitracin zinc ointment containing, in each gram, 500 units of bacitracin zinc in a suitable ointment base.

(a) Combination of active ingredients for the control of dandruff. Salicylic acid identified in §358.710(a)(4) may be combined with sulfur identified in §358.710(a)(7) provided each ingredient is present within the established

(c) Conditions of use in swine—(1) Indications for use and amounts. (i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age. (ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of

Sponsor. See No. 069334 in §510.600 of this chapter. (c) Conditions of use—(1) Intended use. The gene construct directs the expression of that encoding gene such that recombinant, human lysosomal acid lipase (rhLAL) protein intended for the treatment of human disease is present in SBC LAL

(a) [Reserved] (b) Tolerances. The tolerances for amprolium are: (1) Cattle. (i) Liver, kidney, and muscle: 0.5 ppm. (ii) Fat: 2.0 ppm. (2) Chickens and turkeys.

(1) The name of the additive. (2) Adequate directions for use in accordance with the provisions in paragraph (d) of this section. [45 FR 22920, Apr. 4, 1980]

(a) Zirconium-containing complexes have been used as an ingredient in cosmetics and/or cosmetics that are also drugs, as, for example, aerosol antiperspirants. Evidence indicates that certain zirconium compounds have caused human skin granulomas and toxic effects in the lungs and other organs of experimental animals. When used in aerosol form, some zirconium will reach the deep portions of the lungs of users. The lung is an organ, like skin, subject to the

product containing chloroform in residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient, is not, for the purpose of this section, considered to contain chloroform as an ingredient. [41 FR 26845, June 29, 1976]

(a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented

FDA may suspend or revoke the accreditation of an issuing agency if FDA finds, after providing the issuing agency with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the issuing agency or any officer, employee, or other agent of the issuing agency: (a) Has been guilty of misrepresentation or failure to disclose required information in obtaining accreditation;

(a) Identification. Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides. (b) Classification. Class I (general controls). These devices are exempt from the

(a) Identification. A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by

(a) Identification. A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease. (b) Classification. Class I (general controls). The device is

(a) Identification. A Wood's fluorescent lamp is a device intended for medical purposes to detect fluorescent materials (e.g., fluorescein pigment produced by certain microorganisms) as an aid in the identification of these microorganisms. The device aids in the diagnosis of disease. (b) Classification. Class I (general controls). The device is exempt from

(a) Identification. Brucella spp. serological reagents are devices that consist of antigens and antisera used for serological identification of Brucella spp. from cultured isolates derived from clinical specimens or to identify antibodies to Brucella spp. in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent

(a) Identification. Proteus spp. (Weil-Felix) serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), derived from the bacterium Proteus vulgaris used in agglutination tests (a specific type of antigen-antibody reaction) for the detection of antibodies to rickettsia (virus-like bacteria) in

of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling

(a) Identification. A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part

(a) Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded. (b) Classification. Class II (special controls). The special controls for this device are: (1) The device must be