42 C.F.R. PART 7—DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS
Title 42 - Public Health
Authority: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); title V of the Independent Offices Appropriation Act of 1952 (31 U.S.C. 9701); and sec. 352 of the Public Health Service Act, as amended (42 U.S.C. 263).
Source: 52 FR 11073, Apr. 7, 1987, unless otherwise noted.
The provisions of this part are applicable to private entities requesting from the Centers for Disease Control (CDC) reference biological standards and biological preparations for use in their laboratories. Except as otherwise provided in §7.6, a user charge shall be imposed to cover the cost to CDC of producing and distributing reference biological standards and biological preparations. Biological standards means a uniform and stable reference biological substance which allows measurements of relative potency to be made and described in a common currency of international and national units of activity. Biological preparations means a reference biological substance which may be used for a purpose similar to that of a standard, but which has been established without a full collaborative study, or where a collaborative study has shown that it is not appropriate to establish the preparation as an international standard. The charges imposed in §7.2 are based on the amount published in CDC's price list of available products. These charges will reflect direct costs (such as salaries and equipment), indirect costs (such as rent, telephone service, and a proportionate share of management and administrative costs), and the costs of particular ingredients. Charges may vary over time and between different biological standards or biological preparations, depending upon the cost of ingredients and the complexity of production. An up-to-date schedule of charges is available from the Biological Products Branch, Center for Infectious Diseases, Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333. The requester may obtain information on terms of payment and a fee schedule by writing the “Centers for Disease Control,” Financial Management Office, Buckhead Facility, Room 200, Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333. State and local health departments, governmental institutions (e.g., State hospitals and universities), the World Health Organization, and ministries of health of foreign governments may be exempted from paying user charges, when using biological standards or biological preparations for public health purposes.
Title 42: Public Health
PART 7—DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS
Section Contents
§ 7.1 Applicability.
§ 7.2 Establishment of a user charge.
§ 7.3 Definitions.
§ 7.4 Schedule of charges.
§ 7.5 Payment procedures.
§ 7.6 Exemptions.
§ 7.1 Applicability.
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§ 7.2 Establishment of a user charge.
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§ 7.3 Definitions.
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§ 7.4 Schedule of charges.
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§ 7.5 Payment procedures.
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§ 7.6 Exemptions.
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