selenium, and 10 ppm zinc. (c) The viable microbial content of the finished ingredient as a concentrate or dry material is: (1) Less than 10,000 organisms/gram by aerobic plate count. (2) Less than 10 yeasts and molds/gram. (3) Negative for Salmonella, E. coli, coagulase positive Staphylococci

ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in the manufacture of paper and paperboard that contact food. (2) The ingredient is used at levels not to exceed current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.

) The sponsor's compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved; (2) The sponsor's proposed alternative satisfies the requirement; or (3) The applicant's submission otherwise justifies a waiver. [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9585, Mar. 4, 2002]

As used in this subpart: (a) Coal tar. The tar used for medicinal purposes that is obtained as a byproduct during the destructive distillation of bituminous coal at temperatures in the range of 900 °C to 1,100 °C. It may be further processed using either extraction with alcohol and suitable dispersing agents and maceration times or fractional distillation with or without the use of suitable

kittens—(1) Amount. Administer orally at 5 mg dichlorvos per pound of body weight. (2) Indications for use—(i) Dogs and puppies: Removal and control of intestinal roundworms (Toxocara canis and Toxascaris leonina) and hookworms (

(c) Conditions of use in 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)

, every 4 hours. (2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis. (3) Limitations

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

applicants to submit specimens of the labels, enclosures, and containers, or to submit other final printed labeling. Submissions under this paragraph must be made in accordance with part 11 of this chapter except for the requirements of §11.10(a), (c) through (h), and (k), and the corresponding requirements of

(a) Owners or operators of all establishments, not exempt under section 510(g) of the act or subpart D of this part, that engage in the manufacture of blood products shall register and submit a list of every blood product in commercial distribution (except that registration and listing information may be submitted by the parent, subsidiary, and/or affiliate company for all establishments when operations are conducted at more than one establishment and there exists

(a) The following Massachusetts medical device requirements are enforceable notwithstanding section 521 of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: (1) Massachusetts General Laws, Chapter 93, Section 72, to the extent that it requires a hearing test evaluation for a child under the age of 18. (2) Massachusetts General Laws

maintain records of acceptable suppliers, contractors, and consultants. (b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the

Federal Register to make announcements about the standard development process of standard developers other than Federal agencies. (c) Maintain records disclosing the course of development of the proposed standard, the comments and other information submitted by a person in connection with such development (including comments and information regarding the need for a standard), and such other information as may be required to evaluate the standard.

meningoencephalitis (inflammation of the brain and brain membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection in pregnant women that results in a high mortality rate for infants before or after birth. (b) Classification. 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 patient. The special controls are as follows: (i) The performance standard under part 898 of this chapter, and (ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to

(a) Identification. An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac-based paper. The device is intended to remove excessive restorative materials, such as gold, and to smooth rough surfaces from oral restorations, such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive disk, guard for an

with import control authorities under the Act or statutory authority other than the Controlled Substances Import and Export Act. The importer must maintain an official record of the import permit (available from the DEA Diversion Control Division secure network application after issuance) in accordance with part 1304 of this chapter as the record of authority for the importation and shall transmit an official record of the permit to the foreign exporter. If required by the foreign competent

(a) By application pursuant to §1787.10, the Administrator may waive the Buy American requirement upon a showing that application of the requirement would be inconsistent with the public interest or impractical for the RUS Borrower. With respect to impracticality, an RUS Borrower may request a waiver upon a showing that the domestic product is incompatible or impractical

to the offeror. (b) Existing defects. Rural Development does not provide any warranty on property sold from inventory. Subsequent loans may be made, in accordance with applicable loan making regulations for the respective loan program, to correct defects. [50 FR 23904, June 7, 1985, as amended at 53 FR 27837, July 25, 1988]

(c)(1). The Agency and the applicant must concurrently have separate notices of availability published. The notice requirements must be the same as for a final EIS and the information supplement must be circulated in the same manner as a final EIS. The Agency will take no final action on any proposed modification discussed in the information supplement until 30 days after the Agency's notice of availability or the applicant's notice is published, whichever occurs later.

, Rockville, Maryland. (c) Where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http

An applicant for a license, a licensee, or a third party who has participated under §81.30(a)(3) shall have the right to appeal in accordance with the appeal procedures of this subpart any decision of the Commission concerning the grant, denial, interpretation, modification, or revocation of a license under this subpart, by filing a notice of appeal with the Commission within thirty (30) days

Except where otherwise specified, all communications and reports concerning the regulations in this part and applications filed under them should be sent by mail addressed to: ATTN: Document Control Desk, Director, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, via

of witnesses; and (9) Strike or reject duplicative or irrelevant presentations. (b) Where the Commission itself does not preside: (1) The presiding officer may certify questions or refer rulings to the Commission for decision; (2) Any hearing order may be modified by the Commission; and (3) The presiding officer will certify

, Maryland; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e

promptly because of inaction by the applicant, licensee, or permittee or proposals are made for the purpose of delay, a notice shall be issued in accordance with §771.42 or §771.43, as appropriate. The issuance of a notice of contemplated action does not entitle the recipient to a hearing before an

(a) Laboratory tests for reliability and durability. Components, subassemblies, or assemblies that are to be mounted on permissible and approved equipment shall be subjected to two separate vibration tests, each of one-hour duration. The first test shall be conducted at a frequency of 30 cycles per second with a total movement per cycle of 1⁄

for compliance with the requirements of the applicable standards of subpart D of this part until normal ventilation is restored, or (2) All persons, except those working on the fan, shall be withdrawn, the ventilation shall be restored to normal and the air quality in the affected active workings shall be tested by a competent person to assure that the air quality meets the requirements of the standards in subpart D of this part, before any other persons are

which coal is being cut, mined, drilled for blasting, or loaded; and (ii) To any other working places as required by the approved ventilation plan. (2) These devices shall be installed at a distance no greater than 10 feet from the area of deepest penetration to which any portion of the face has been advanced unless an alternative distance is specified and approved in the ventilation plan. Alternative distances specified shall

(a) When auxiliary fans and tubing are used for face ventilation, each auxiliary fan shall be— (1) Permissible, if the fan is electrically operated; (2) Maintained in proper operating condition; (3) Deenergized or shut off when no one is present on the working section; and (4) Located and operated to avoid recirculation of air