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21 CFR 26.66 - Designation and listing procedures.

§ 26.66
Designation and listing procedures.
The following procedures shall apply with regard to the designation of conformity assessment bodies (CAB's) and the inclusion of such bodies in the list of CAB's in subpart B of this part:
(a) The designating authority identified in subpart B of this part shall designate CAB's in accordance with the procedures and criteria set forth in subpart B of this part;
(b) A party proposing to add a CAB to the list of such bodies in subpart B of this part shall forward its proposal of one or more designated CAB's in writing to the other party with a view to a decision by the Joint Committee;
(c) Within 60 days following receipt of the proposal, the other party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the inclusion in subpart B of this part of the proposed CAB or CAB's shall take effect; and
(d) In the event that the other party contests on the basis of documented evidence the technical competence or compliance of a proposed CAB, or indicates in writing that it requires an additional 30 days to more fully verify such evidence, such CAB shall not be included on the list of CAB's in subpart B of this part. In this instance, the Joint Committee may decide that the body concerned be verified. After the completion of such verification, the proposal to list the CAB in subpart B may be resubmitted to the other party.

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 552 - Public information; agency rules, opinions, orders, records, and proceedings

USC : Title 15 - COMMERCE AND TRADE

§ 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity

§ 1454 - Rules and regulations

§ 1455 - Procedure for promulgation of regulations

USC : Title 18 - CRIMES AND CRIMINAL PROCEDURE

§ 1905 - Disclosure of confidential information generally

USC : Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360b - New animal drugs

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

21 USC § 360e–1 - Pediatric uses of devices

§ 360f - Banned devices

§ 360g - Judicial review

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

21 USC § -

§ 360m - Accredited persons

§ 371 - Regulations and hearings

§ 374 - Inspection

§ 381 - Imports and exports

§ 382 - Exports of certain unapproved products

§ 383 - Office of International Relations

§ 393 - Food and Drug Administration

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 216 - Regulations

§ 241 - Research and investigations generally

42 USC § -

§ 262 - Regulation of biological products

§ 264 - Regulations to control communicable diseases

§ 265 - Suspension of entries and imports from designated places to prevent spread of communicable diseases