in the case of a letter of exemption, that the laboratory is no longer eligible for such letter of exemption.

§ 74.61 Contents of notice.

(a) General. A notice issued pursuant to section 74.60 shall contain a statement of the proposed action and of the grounds upon which the action is proposed to be taken.

(b) Suspension. Where it is proposed to suspend a license or letter of exemption, (1) the period of such proposed suspension or the action which will be required to end the suspension shall be stated in the notice, and (2) the notice shall provide that if the appropriate remedial action is not taken within the period of suspension prescribed, the license or letter will be revoked.

(c) Limitation. Where it is proposed to limit a license or letter of exemption, the procedures or categories of procedures with respect to which the license or letter will no longer be applicable shall be stated in the notice.

Subpart 1-Hearings [Reserved]

fits for Federal employees), or under the Retired Federal Employees Health Benefits Act, or which participates in the carrying out of any such contract, to issue in any State contracts entitling any person as a beneficiary to receive comprehensive medical services (as defined in paragraph (b) of this section) from a group practice unit or organization (as defined in paragraph (c) of this section) with which such carrier has contracted or otherwise arranged for the provision of such services.

(b) As used in this paragraph, the term "comprehensive medical services" means comprehensive preventive, diagnostic, and therapeutic medical services (as defined in regulations of the Secretary), furnished on a prepaid basis; and may include, at the option of a carrier, such other health services including mental health services, and equipment and supplies, furnished on such terms and conditions with respect to copayment and other matters, as may be authorized in regulations of the Secretary.

(c) As used in this paragraph:

(1) The term "group practice unit or organization" means a nonprofit agency, cooperative, or other organization undertaking to provide, through direct employment of, or other arrangements with the members of a medical group, comprehensive medical services (or such services and other health services) to members, subscribers, or other persons under contract of carriers.

(2) The term "medical group" means a partnership or other association or group of persons who are licensed to practice medicine in a State (or of such persons and persons licensed to practice dentistry or optometry) who (1) as their principal professional activity and as a group responsibility, engage in the coordinated practice of their profession primarily in one or more group practice facilities, (ii) pool their income from practice as members of the group and distribute it among themselves according to a prearranged plan, or enter into an employment arrangement with a group practice unit or organization for the provision of their services, (iii) share common overhead expenses (if and to the extent such expenses are paid by members of the group), medical and other records, and substantial portions of the equipment and professional, technical and administrative staff, and (iv) include within the group at least such professional personnel, and make available at least such health services, as may be specified in regulations of the Secretary.

(d) Nothing in this section shall preclude any State or State agency from regulating the amounts charged for contracts issued pursuant to paragraph (a) of this section or the manner of soliciting and issuing such contracts, or from regulating any carrier issuing such contracts in any manner not inconsistent with the provisions of this section.

All terms not defined herein shall have the same meaning given them in the Act. As used in this subpart:

(a) "Act" means Title IV of Public Law 91-515, 84 Stat. 1309.

(b) "Secretary" means the Secretary of Health, Education, and Welfare, and the officer or employee to whom the authority involved has been delegated.

(c) "Eligible carrier" means any carrier which is a party to a contract entered into under 5 U.S.C. Ch. 89 or which participates in the carrying out of any such contract by direct assumption of liability, reinsurance, or otherwise.

(d) "Comprehensive medical services" means that combination of preventive, diagnostic, and therapeutic medical and health services which the Secretary finds, on the basis of information submitted to him by an eligible carrier, is reasonably calculated to assure the protection, maintenance, and support of health and the satisfactory diagnosis and treatment of illness and injury of persons enrolled under the contract proposed to be issued by such carrier, taking into consideration such factors as the nature and size of the population to be served, the geographic area to be served, the availability of resources, and other related elements.

(e) The term "nonprofit" as applied to any agency, cooperative, or other organization under section 401(c) (1) means an agency, cooperative, or other organization no part of the net earnings of which inures, or may lawfully inure, to the benefit of any private shareholder or individual. However, in the case of an organization the purposes of which include the provision of personal health services to its members or subscribers or their dependents under a plan of such organization for the provision of such services to them (which plan may include the provision of other services or insurance benefits to them), the net earnings may be distributed through the provision of such health services (or such other services or insurance benefits) to such members or subscribers or dependents under such plan.

§ 75.3 Application for authorization.

(a) Any eligible carrier may submit an application to the Secretary for an authorization pursuant to § 75.4.

(b) Such application shall be in writing, executed by an officer of the carrier authorized for such purpose, and shall set forth the following:

(1) The name, address, and home office of the carrier.

(2) The status of the carrier as a contractor under 5 U.S.C. Ch. 89, or as a participant in carrying out any such contract.

(3) A full description of the medical services proposed to be furnished on a prepaid basis and a statement designed to show that such services constitute comprehensive medical services as defined herein.

(4) A full description of health services to be furnished at the option of the carrier, such as dental, mental health, hospital, optometric, or nursing home services, or equipment and other supplies, and the terms and conditions upon which such services and supplies are to be furnished.

(5) Identification of the group practice unit or organization, and medical groups considered to meet the requirements of the Act and of this part, and of other organizations and facilities, proposed to be utilized in the provision of services under the contract, together with a description of the services or resources to be provided by each such group, organization or facilities under arrangements made by the carrier.

(6) The method which will be used for monitoring and evaluating the quality and utilization of services provided under the contract.

(7) A copy of the proposed contract to be issued to persons enrolled in the plan which shall not exclude an individual because of race, color, sex, religion, or national origin and which shall set forth a detailed statement of benefits offered, including out-of-area benefits.

(8) Identification of the State in which the carrier proposes to issue contracts, and a citation to the provisions of State law or other legal requirements of the State which in the opinion of legal counsel restricts the issuance of such contracts by the carrier, or which restricts the operation of any group practice unit or organization with which the carrier has contracted or proposes to contract insofar as such requirement operates to prevent such group from arranging with the carrier for payment

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on a prepaid basis for services provided to persons under contract of such carrier or from providing such services through a medical group together with a copy of the opinion of such counsel.

(9) An agreement to furnish such reports as the Secretary may reasonably require as to operations under the authorization.

(10) An agreement that the carrier will require any individual, agency, organization, or other entity with which it contracts or otherwise arranges for the provision of services, pursuant to an authorization under the Act, to provide such services without discrimination on account of race, color, sex, religion, or national origin.

(11) An agreement to report promptly any change in the contract or benefits provided thereunder, and insofar practicable, at least 90 days before such change becomes effective.

as

(12) An agreement to provide such other information as the Secretary may reasonably require.

§ 75.4

Issuance of authorization.

(a) The Secretary may, upon the basis of an application approved by him as meeting the requirements of the Act and of this part, authorize an eligible carrier to issue in one or more States contracts entitling any person as a beneficiary to receive comprehensive medical services furnished on a prepaid basis either from a group practice unit or organization with which such carrier has contracted or otherwise arranged for the provision of such services, if he finds that such authorization is necessary, by reason of the laws of the State with respect to which the application is made, to permit the carrier to issue such contracts.

(b) The issuance of such an authorization shall preclude the application of any law, regulation or other requirement of the State with respect to which the authorization is issued which, except as authorized in section 401(d) of the Act, prohibits, restricts, or limits

(1) The issuance of any contract by the carrier in accordance with such authorization, including, but not limited to restrictions on the provision of medical care or services on a prepaid, capitation basis or on the number of plans operating

in a given geographical area, prohibitions on the issuance of such contracts by an out-of-State corporation or a corporation for profit or requirements that a percentage or given number of professional personnel or medical facilities in any area participate or be allowed to participate in the provision of services as a condition to the operation of the plan in such area, or that the members of the carrier's governing board meet specified qualifications or conditions as to their appointment, or

(2) The operation of any group practice unit or organization with which the carrier has contracts insofar as such requirement operates to prevent such group from arranging with the carrier for payment on a prepaid basis for services provided to persons under contract of such carrier or from providing such services through a medical group.

(c) An authorization issued under this section, unless suspended or terminated as provided herein, shall be valid so long as the carrier maintains its status as an eligible carrier and for such additional period as the Secretary finds necessary to permit the carrier to liquidate any obligations for service it may have incurred and to permit beneficiaries under the plan to make other arrangements for coverage.

(d) An authorization may be suspended or terminated upon reasonable notice to the carrier, with opportunity for hearing if the carrier fails to comply with any assurance, representation, or agreement contained in its application, or fails to meet any requirement of the Act or regulations for the provision of services under contracts issued pursuant to this part.

Pursuant to delegations of authority from the Secretary and Assistant Secretary (Health and Scientific Affairs) the Administrator, Consumer Protection and Environmental Health Service, has the authority to issue and approve regulations and to perform all other functions vested in the Secretary under the Radiation Control for Health and Safety Act of 1968 (Public Law 90-602; 42 U.S.C. 263b et seq.).

§ 78.2 Redelegation of Authority to Commissioner, ECA.

The Administrator, Consumer Protection and Environmental Health Service has redelegated to the Commissioner, Environmental Control Administration, all of the authority under the Act previously delegated to the Administrator and has specified that this authority, except for the authority to issue and approve regulations, may be redelegated with the consent of the Administrator.

ble authority under the Act which has been delegated to the Commissioner by the Administrator, except the authority to:

(a) Exempt, under section 358(a) (5) of the Act, any electronic product intended for use by departments or agencies of the United States from the provisions of section 358 of the Act.

(b) Establish a Technical Electronic Product Radiation Safety Standards Committee under section 358(f) of the Act and appoint members thereto.

(c) Exempt manufacturers from the notification provisions of or direct manufacturers to notify the persons specified in section 359 (b) of the Act.

(d) Exempt any electronic product or class of electronic product as provided under section 360B (b) of the Act.

(e) Remit or mitigate any civil penalty imposed for violation of the Act as provided in section 360C (b) (2) of the Act. Subpart B-Definitions, Interpretations, and Statements of General Policy

AUTHORITY: The provisions of this Subpart B issued under secs. 215, 356, 58 Stat. 690, 82 Stat. 1174; 42 U.S.C. 216, 263d.

SOURCE: The provisions of this Subpart B appear at 35 F.R. 890, Jan. 22, 1970, unless otherwise noted.

§ 78.100 Definitions and interpretations. As used in Part 78:

(a) "Electronic product radiation"

means

(1) Any ionizing or nonionizing electromagnetic or particulate radiation, or

(2) Any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

(b) "Electromagnetic radiation" includes the entire electromagnetic spectrum of radiation of any wavelength. The electromagnetic spectrum illustrated in Figure 1 includes, but is not limited to, gamma rays, X-rays, ultraviolet, visible, infrared, microwave, radiowave, and low frequency radiations.

(c) "Particulate radiation" is defined as charged particles such as protons, electrons, alpha particles, heavy particles, etc., which have sufficient kinetic energy to produce ionization or atomic or electron excitation by collision, electrical attractions or electrical repulsion or uncharged particles such as neutrons, which can initiate a nuclear transforma