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particularity the facts that justify the order.

(c)(1) A written order issued under paragraph (a)(1) of this section will ordinarily provide that the HCT/P be recalled and/or destroyed within 5 working days from the date of receipt of the order. After receipt of an order issued under paragraph (a)(1) of this section, the establishment in possession of the HCT/P must not distribute or dispose of the HCT/P in any manner except to recall and/or destroy the HCT/P consistent with the provisions of the order, under the supervision of FDA.

(2) In lieu of paragraph (c)(1) of this section, other arrangements for assuring the proper disposition of the HCT/P may be agreed upon by the person receiving the written order and FDA. Such arrangements may include, among others, providing FDA with records or other written information that adequately ensure that the HCT/P has been recovered, processed, stored, and distributed in conformance with this part, and that, except as provided under $$ 1271.60, 1271.65, and 1271.90, the donor of the cells or tissue for the HCT/ P has been determined to be eligible.

(d) A written order issued under paragraph (a)(3) of this section will specify the regulations with which you must achieve compliance and will ordinarily specify the particular operations cov

ered by the order. After receipt of an order that is in effect and issued under paragraph (a)(3) of this section, you must not resume operations without prior written authorization of FDA.

(e) The recipient of an order issued under this section may request a hearing in accordance with part 16 of this chapter. To request a hearing, the recipient of the written order or prior possessor of such HCT/P must make the request within 5 working days of receipt of a written order for retention, recall, destruction, and/or cessation or within 5 working days of the agency's possession of an HCT/P under paragraph (a)(2) of this section), in accordance with part 16 of this chapter. An order of destruction will be held in abeyance pending resolution of the hearing request. Upon request under part 16 of this chapter, FDA will provide an opportunity for an expedited hearing for an order of cessation that is not stayed by the Commissioner of Food and Drugs.

(f) FDA will not issue an order for the destruction of reproductive tissue under paragraph (a)(1) of this section, nor will it carry out such destruction itself under paragraph (a)(2) of this section.

PARTS 1272-1299 (RESERVED)

FINDING AIDS

A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetcal list of agencies publishing in the CFR are included in the CFR Index and 'inding Aids volume to the Code of Federal Regulations which is published sepaately and revised annually.

Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected

Material Approved for Incorporation by Reference

(Revised as of April 1, 2006)

The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.

21 CFR (PARTS 800 TO 1299)
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES

21 CFR

American College of Radiology, Committee on Quality Assurance in Mammography, Mammography Accreditation Program

1891 Preston White Dr., Reston, VA 22091-5431 Mammography Quality Control: Radiologist's Manual, Radiologic 900.12(d)

Technologists's Manual, Medical Physicist's Manual, 1992 edition. Mammography Quality Control Manual, 1994 edition

900.12(a)

American Society for Testing and Materials

100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, Tele

phone (610) 832-9585, FAX (610) 832-9555
ASTM D 412-68 Standard Method of Tension Testing of Vulcanized 801.410

Rubber.
ASTM D 412–97 Standard Test Methods for Vulcanized Rubber and 801.410(d)(2)

Thermoplastic Rubbers and Thermoplastic Elastomers—Tension.
ASTM D 1415-68 Test for International Hardness of Vulcanized Rub- 801.410

ber.
ASTM D 1415-88 Standard Test Method for Rubber Property-Inter- 801.410(d)(2)

national Hardness.
ASTM D 3492–83 Standard Specification for Rubber Contraceptives 801.430(1)(2)

(Condoms). ASTM D 3492–96 Standard Specification for Rubber Contraceptives 801.430(f)(2)

(Male Condoms).

American National Standards Institute

11 West 42nd Street, New York, NY 10036 Telephone: (212) 642–

4900 ANSI C81.10–1976 Specifications for Electric Lamp Bases and Hold- 1040.20(c)

ers-Screw Shall Types.
ANSI S3.22–1987 Specification of Hearing Aid Characteristics (ASA 801.420(c)(4)

70–1987).
Available from: Standards Secretariat, Accoustical Society of Amer-

ica, 120 Wall Street, 32nd Floor, New York, NY 10005-3993
ANSI S3.22–1996, Specification of Hearing Aid Characteristics (ASA 801.420(c)(4)

70–1996).

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