. This organism is responsible for a variety of inflammations of the skin following skin abrasions from contact with fish, shellfish, or poultry. (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 limitations in

detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans

(a) Identification. Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height

(a) Identification. A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.

completion 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 ocular plethysmograph that was in commercial distribution before May 28, 1976. Any other ocular plethysmograph shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987

-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity. (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 limitations in

(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint. (b) Classification. (1) Class II (performance standards). (2) Class I for the

. Class II (special controls). A discography kit intended for use with a photofluorographic 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. [48 FR 53047, Nov. 23, 1983, as amended at

When a sample of a product to be offered for importation has been requested by the Secretary, the District Director of Customs having jurisdiction over the shipment shall, upon the arrival of the shipment, procure the sample and shall give to its owner or consignee prompt notice of the delivery or of the intention to deliver such sample to the Secretary. If the notice so requires, the owner or consignee will hold the shipment of which the sample is typical and not release such shipment until

(a) There shall be adequate toilet, washroom, locker, and other essential sanitary facilities readily accessible for use of employees adjacent to places or areas where land and air conveyances are serviced, maintained, and cleaned. These facilities shall be maintained in a clean and sanitary condition at all times. (b) In the case of diners not in a train but with a crew on board, adequate toilet facilities shall be available to the

Any manufacturer assigned an individual manufacturing quota for any basic class pursuant to §1303.23 may at any time abandon his right to manufacture all or any part of such quota by filing with the Drug & Chemical Evaluation Section a written notice of such abandonment, stating the name and Administration Controlled Substances Code Number, as set forth in part

of destruction shall be sufficient to render all such controlled substances non-retrievable. When the actual substances collected for destruction are unknown but may reasonably include controlled substances, the method of destruction shall be sufficient to render non-retrievable any controlled substance likely to be present. (c) The method of destruction shall be consistent with the purpose of rendering all controlled substances to a non-retrievable state in order

) ONDCP may assess interest charges beginning the 31st day of billing. Interest will be at the rate prescribed in section 3717 of title 31 of the United States Code and will accrue from the date of the billing. (d) ONDCP may assess search charges where records are not located or where records are exempt from disclosure. (e) ONDCP may aggregate individual requests and charge accordingly for requests seeking portions of a document or

operating active landfills. (c) Provide technical assistance and/or training for operators of landfills which are closed or will be closed in the near future with the development/implementation of closure plans, future land use plans, safety and maintenance planning, and closure scheduling within permit requirements. (d) Evaluate current landfill conditions to determine the threats to water resources. (e) Pay

(a) The Water and Waste Grant Agreement for rural and native villages in Alaska, or other approved form(s) will be executed by all applicants. To view all forms and agreements, refer to the USDA RUS Water and Environmental Programs Web site. (b) Grant funds will be distributed from the Treasury at the time they are actually needed by the applicant using multiple advances. Instructions regarding disbursement of funds can be found in the

(a) Loans under this subpart are subject to the provisions of §1942.17 (l) of subpart A of this part 1942. (b) The District Director will, with assistance as necessary by the State Director and OGC, concur in agreements between borrowers and third parties such as contracts for professional and technical services. The State Director may

Administrator will exercise this authority upon request of the State Director with the recommendation of the appropriate program Assistant Administrator or upon a request initiated by the appropriate program Assistant Administrator. Requests for exceptions must be made in writing and supported with documentation to explain the adverse effect, propose alternative courses of action, and show how the adverse effect will be eliminated or minimized if the exception is granted.

(a) General. OAO shall apply the standards set forth in this subpart in requiring awardee organizations to account for program income related to projects financed in whole or in part with Federal funds. (b) Addition method. Unless otherwise provided in the authorizing statute, in accordance with the terms and conditions of the award, program income earned

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection

(a) Each licensee, certificate holder, or other person possessing classified information shall establish a reproduction control system to ensure that reproduction of classified material is held to the minimum consistent with operational requirements. Classified reproduction must be accomplished by authorized employees knowledgeable of the procedures for classified reproduction. The use of technology that prevents, discourages, or detects the unauthorized reproduction

(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conductor sponsor, and a person is not required to respond to, a collection

(a) A notice of oral hearing will: (1) State the time, place and issues to be considered; (2) Provide names and addresses of participants; (3) Designate the presiding officer; (4) Specify the time limit for participants and others to indicate whether they wish to present views; and (5) State any

Except as provided in §§150.15, 150.16, 150.17, 150.17a, and 150.19, any person in an Agreement State who manufactures, produces, receives, possesses, uses, or transfers byproduct material, source material, or special nuclear material in quantities not sufficient to form a critical mass is exempt from the requirements for a license contained in Chapters 6, 7, and 8 of

DOE of such negotiations. Such notice shall be made no later than the later of 30 days after the effective date of this regulation or within 14 days after such negotiations meet the conditions of this section, and shall specify all persons involved and the host government affected. Notice must be in writing to the Assistant Administrator for International Energy Affairs. Where this notice pertains to negotiations to modify a supply agreement previously reported to the Department of Energy under

prescribe for the administration of financial assistance under this part. (b) The budget period(s) covered by the financial assistance provided to a State according to §420.11(b) or §420.33 shall be consistent with 10 CFR part 600. (c) Subawards

the notice of proposed penalty. (b) If within 60 calendar days of receiving the assessment order in paragraph (a) of this section the respondent does not pay the civil penalty amount, DOE shall institute an action in the appropriate United States District Court for an order affirming the assessment of the civil penalty. The court shall have authority to review de novo the law and the facts involved and shall have jurisdiction to enter a judgment enforcing, modifying

(d) A routine violator must file a Notice of Intent to Appeal with the Office of Hearings and Appeals within three business days of the date of the Notice of Finding of Routine Violation, serving a copy on the Office of the Assistant General Counsel for Enforcement to retain the ability to buy central air conditioners during the pendency of the appeal. [81 FR 45403, July 14, 2016]

The Director shall permit the conditional importation or bringing into the United States of any firearm for the purpose of examining and testing the firearm in connection with making a determination as to whether the importation or bringing in of such firearm will be authorized under this subpart. An application under this section shall be filed on Form 6 (Firearms), in triplicate, with the Director. The Director may impose conditions upon any importation under this

explosion-proof integrity of the enclosure. (d) Spacing of fastenings. (e) Length of thread engagement on fastenings and threaded parts that assure the explosion-proof integrity of the enclosure. (f) Use of lockwasher or equivalent with all fastenings. (g) Dimensions which affect compliance with the requirements for packing gland parts in

Explosion-proof compartment. An enclosure that withstands internal explosions of methane-air mixtures without damage to itself or discharge of flame and without ignition of surrounding explosive methane-air mixtures. (d) Permissible. Completely assembled and conforming in every respect with the design formally approved by MSHA under this part. (Approvals under this part are given only to equipment for