(a) Identification. An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures

(a) Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound. (b) Classification. Class I (general controls). The device is exempt from the premarket

(a) Identification. Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness. (b) Classification. Class I (general

(a) Identification. A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes. (b) Classification. Class I (general controls). The device is exempt from the

(a) Identification. An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail. (b) Classification. Class I (general controls). The AC-powered device and the battery-powered device are

(a) Identification. A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction

(a) The Commissioner of Food and Drugs shall approve any watering point if (1) the water supply thereat meets the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations as set forth in 40 CFR part 141, and (2) the methods of and facilities for delivery of such water to the conveyance and the sanitary conditions surrounding such delivery prevent the introduction, transmission, or spread of communicable diseases.

(a) The requirement of registration is waived for the following persons in the circumstances described in this section: (1) Any officer or employee of the Administration, any customs officer, any officer or employee of the U.S. Food and Drug Administration, and any Federal or Insular officer who is lawfully engaged in the enforcement of any federal law relating to listed chemicals, controlled substances, drugs, or customs, and is

shortage is imminent, and that the proposed project will eliminate or alleviate the problem. For projects to be funded in accordance with §1778.11 (a), evidence must be furnished that a significant decline in quantity or quality occurred within two years before filing the application with the Agency, or is expected to occur within one year after filing the application. (b

(a) General. The Agency may approve mergers or consolidations (herein referred to as “mergers”) when the resulting organization will be eligible for an Agency guaranteed loan and assumes all the liabilities and acquires all the assets of the merged borrower. Mergers may be approved when: (1) The merger is in the best interest of the Government and the merging borrower;

putting together a facility that is a part of, or physically attached to, real estate. This does not include procurement of major equipment even though the equipment may be custom built to meet the owner's requirements. Owner. An applicant or borrower. Processing office. The office designated by the State program official to accept and process applications for

signed by the State Director and given after completion of the training. Efforts will be made by the appropriate Agency office to complete this training process and certify packagers as quickly as possible. Grantees must attend this training each year in order to qualify for assistance. [58 FR 58643, Nov. 3, 1993, as amended at 61 FR 39851, July 31, 1996]

, address, and telephone number; (2) Status of the account including the amount of the loan, the repayment schedule, and the amount of the delinquency; and (3) Other information needed for counseling purposes which may be provided in accordance with RD Instruction 2018-F.

This subpart delegates authority and prescribes procedures for the liquidation of loans to individuals and to organizations as identified in §1955.3 of this subpart. It pertains to the Multi-Family Housing (MFH) and Community Facility (CF) programs of the Rural Housing Service (RHS), and direct programs of the Rural Business-Cooperative Service (RBS). Guaranteed RBS

This subpart delegates authority and prescribes policies and procedures for debt settlement of Community Facility loans; Association Recreation loans; Rural Renewal loans; direct Business and Industry loans; Rural Development Loan Fund loans; Intermediary Relending Program loans; and the Rural Microentrepreneur Assistance Program (RMAP) loans and repayable portions of RMAP grants; and Shift-in-land-use loans. Settlement of Economic Opportunity Cooperative loans

) Approved budget plan for categorizing allocable project funds to accomplish the stated purpose of the award; and (10) Other information or provisions deemed necessary by OEPNU and the Authorized Departmental Officer to carry out the awarding activities or to accomplish the purpose of a particular award. (b) [Reserved]

Except where otherwise specified in this part, all communications and reports concerning the regulations in this part should be addressed to the Deputy Director of the NRC's Office of International Programs, either by telephone to 301-287-9057; by mail to the 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

Each holder of a part 50 construction permit, or a holder of a combined license under part 52 of this chapter before the date that the Commission had made the finding under 10 CFR 52.103(g), who also holds a license under part 70 of this chapter authorizing ownership, possession and storage only of special nuclear material at the site of the nuclear reactor for use as fuel in operation of the nuclear reactor after issuance of either an operating license under 10 CFR

, 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-mail to [email

response shall be provided to the applicant, the Federal Energy Regulatory Commission, any State Regulatory Agency having responsibility for service standards or rates of any “entity” that may be directly involved in the proposed action, and the appropriate Regional Electric Reliability Council. Pursuant to section 202(c) of the Federal Power Act, DOE may issue an emergency order even though a designated “entity” has failed to file a timely response.

(a) If a person refuses to permit a duly authorized representative of the Department of Energy to have access to any premises or source of information necessary to the administration or the enforcement of the Defense Production Act and other applicable statutes, this part, or official actions, the Department of Energy representative may seek compulsory process. Compulsory process means the institution of appropriate legal action, including ex parte application for an

(a) Any party found to be in violation of the regional standards may remediate by replacing the noncompliant unit at cost to the violator; the end user cannot be charged for any costs of remediation. (1) If a violator is unable to replace all noncompliant installations, then the Department may, in its discretion, consider the remediation complete if the violator satisfactorily demonstrates to the Department that it attempted to

evidence establishing such exportation under this section will relieve the actual exporter and the person selling to the exporter for exportation from transfer tax liability. Where satisfactory evidence of exportation of a firearm is not furnished within the stated period, the transfer tax will be assessed.

All orders, notices, motions, and other formal documents required to be served under the regulations in this part may be served by mailing a signed, original copy thereof to the designated representative of the applicant, licensee, or permittee by certified mail, with request for return receipt card, at the representative's business address, by personal service, or as otherwise agreed to by the parties. If the applicant, licensee, or permittee has not yet designated a representative, all

(b) Units with electrical parts designed to operate only outby the last open crosscut in a gassy coal-mine entry, room, or other opening (including electric-drive units with their controls and push buttons) are not required to comply with the provisions of Part 18 of Subchapter D of this chapter (Bureau of Mines Schedule 2, revised, the current revision of which is Schedule 2F). (c) Units with electrical parts and designed for operation only in

the drawings, specifications, and descriptions that relate to equipment which has received a certificate of approval, and these are to be adhered to exactly in production of the certified equipment. (c) A certificate of approval will be accompanied by an appropriate caution statement specifying the conditions to be observed for operating and maintaining the equipment and to preserve its permissible status.

(b) Hearings on issues of fact. Where a genuine question of material fact is raised, the administrative law judge shall, and in any other case may, set the case for an evidentiary hearing in accordance with Subpart C of this part.

discharge operating controls. The controls shall be located so that spills or overruns will not endanger persons. (b) Where persons are required to move around or over any facility listed in this standard, suitable walkways or passageways shall be provided. (c) Where persons are required to enter any facility listed in this standard for maintenance or inspection purposes, ladders, platforms, or staging shall be provided. No person shall

(a) Operators of mines which have experienced a rock burst shall— (1) Within twenty four hours report to the nearest MSHA office each rock burst which: (i) Causes persons to be withdrawn; (ii) Impairs ventilation; (iii) Impedes passage; or (iv) Disrupts mining activity for more than one