The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in §341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride.

The active ingredients of the product consist of any of the following, within the established concentrations for each ingredient: (a) Cellulose derivatives: (1) Carboxymethylcellulose sodium, 0.2 to 2.5 percent. (2) Hydroxyethyl cellulose, 0.2 to 2.5 percent. (3) Hypromellose, 0.2 to 2.5 percent.

As appropriate to the nature of the preventive control and its role in the facility's food safety system you must: (a) Establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls; and (b) Monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.

(2) Indications for use. As an anti-inflammatory and analgesic agent. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 21566, May 13, 1983, as amended at 78 FR 28824, May 20, 2014]

dogs and cats—(1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours. (2) Indications for use. Treatment of respiratory, urogenital, skin, and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium. (3) Limitations. Federal law restricts this drug

(a) [Reserved] (b) Tolerances. The tolerances for penicillin are: (1) Cattle. (i) Edible tissues (excluding milk): 0.05 ppm. (ii) Milk: Zero. (2) Chickens. Edible tissues: Zero.

(a) [Reserved] (b) Tolerances. The tolerances for tylosin are: (1) Cattle. (i) Liver, kidney, fat, and muscle: 0.2 ppm. (ii) Milk: 0.05 ppm. (2) Chickens and turkeys.

, if applicable; (k) The patient followup plan, if applicable; (l) The procedures for monitoring conduct and progress of the surveillance; (m) An estimate of the duration of surveillance; (n) All data analyses and statistical tests planned; (o) The content and timing of reports.

standard that the person submitting the standard believes are appropriate for adoption as, or inclusion in, the proposed standard; and (3) A summary of the test data, or, if requested by the Food and Drug Administration, all such data or other information supporting the specific portions of the standard identified by the person submitting the standard. (b) The Food and Drug Administration will publish a notice in the

§866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See §866.1(e) for the availability of this guidance document. [76 FR 14274, Mar. 9, 2012, as amended at

approval application (PMA) or notice of completion of product development protocol (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 April 21, 1997, for any endodontic dry heat sterilizer that was in commercial distribution

cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear. (b) Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is

) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 11, 2000, for any penile inflatable implant that was in commercial distribution before May 28, 1976

(a) Identification. An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (

. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of

(a) Identification. An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient. (b) Classification. Class I (general controls). The device

(a) Identification. A simulatan (including crossed cylinder) is a device that is a set of pairs of cylinder lenses that provides various equal plus and minus refractive strengths. The lenses are arranged so that the user can exchange the positions of plus and minus cylinder lenses of equal strengths. The device is intended for subjective refraction (refraction in which the patient judges whether a given object is clearly in

Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the

For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if: (a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;

produced, and the approximate number of such product units which have left the place of manufacture; (c) The expected usage for the product if known to the manufacturer; (d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; (e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal

Reagents. Reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate. (c) In-house reagents. You must validate and/or verify the processes used for production of in-house reagents. (d) Records. You must maintain the following records pertaining to supplies and reagents: (1) Records

(a) The Administrator shall exempt from payment of an application fee for registration or reregistration: (1) Any hospital or other institution which is operated by an agency of the United States (including the U.S. Army, Navy, Marine Corps., Air Force, and Coast Guard), of any State, or any political subdivision or agency thereof. (2) Any individual practitioner who is required to obtain an

to the hearing, unless the applicant or registrant waives such notice and requests the hearing be held at an earlier time, in which case the Administrator shall fix a date for such hearing as early as reasonably possible. (c) The hearing shall commence at the place and time designated in the notice given under paragraph (b) of this section or in the notice of hearing published in the Federal Register

(5) “Letter of Conditions”; (6) Form RD 1942-46, “Letter of Intent to Meet Conditions”; (7) Form RD 1940-1, “Request for Obligation of Funds”; (8) Completed environmental review documents including copies of public notices and appropriate proof of publication, if applicable; and (9) Grant determination, if applicable. (b

subject to 2 CFR part 421, Requirements for Drug-Free Workplace (Financial Assistance), implementing the Drug-Free Workplace Act of 1988 (41 U.S.C. 8102). [79 FR 76007, Dec. 19, 2014, as amended at 81 FR 7698, Feb. 16, 2016]

(a) DEC and ANTHC utilize the National Indian Health Service, Sanitation Deficiency System (SDS) database as a comprehensive source of rural sanitation needs in Alaska. The database provides an inventory of the sanitation deficiencies including water, sewer, and solid waste facilities for existing homes. The sanitation deficiencies data are updated annually by DEC and ANTHC in consultation with the respective recipient communities. The SDS system is utilized in the

The following officials and employees of the Rural Development, in accordance with applicable laws, and the regulations implementing these laws, for and on behalf of, and in the name of the United States of America or the Rural Development, are also severally authorized within the area of their respective jurisdictions to perform the acts specified in paragraphs (g) through (r) of

applications for very low- and low-income applicants. To meet this requirement it must have the necessary background and experience with proven ability to perform responsibly in the field of housing application packaging, low-income housing development, or other business or administrative ventures which indicate an ability to perform responsibly in this field of housing application packaging. (b) Legally obligate itself to administer grant funds, provide adequate accounting

grantee is targeting a different geographic area, a new preapplication must be submitted in accordance with §1944.410 and the grantee may apply for a predevelopment grant in accordance with §1944.410(d). In addition to meeting the conditions of an applicant as defined in

handbooks, the Catalog of Federal Domestic Assistance, or any other appropriate means, research program areas for which proposals will be solicited competitively, to the extent that funds are available. (c) The regulations of this part do not apply to research, extension or education grants awarded by the Department of Agriculture under any other authority. [64 FR 34103, June 24, 1999]