[Federal Register Volume 65, Number 136 (Friday, July 14, 2000)]
[Rules and Regulations]
[Page 43690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17811]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 821, 895, and 900

[Docket No. 00N-1361]


Code of Federal Regulations; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to correct some errors that have become incorporated into 
the regulations. This action is being taken to improve the accuracy of 
the regulations.

DATES: This rule is effective July 14, 2000.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy, 
Planning, and Legislation (HF-927), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: FDA has discovered that errors have been 
incorporated into the agency's codified regulations for 21 CFR parts 
821, 895, and 900. This document corrects those errors. Publication of 
this document constitutes final action under the Administrative 
Procedure Act (5 U.S.C. 553). FDA has determined that notice and public 
comment are unnecessary because this amendment is nonsubstantive.

List of Subjects

21 CFR Part 821

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

21 CFR Part 900

    Electronic products.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
821, 895, and 900 are amended as follows:

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

    1. The authority citation for 21 CFR part 821 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 
374.

Sec. 821.50  [Amended]

    2. Section 821.50 Availability is amended in paragraph (a) by 
removing ``Form FD 482'' and by adding in its place ``Form FDA 482''.

PART 895--BANNED DEVICES

    3. The authority citation for 21 CFR part 895 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.

Sec. 895.21  [Amended]

    4. Section 895.21 Procedures for banning a device is amended in the 
fourth sentence of paragraph (d)(8) by removing ``201(y)'' and by 
adding in its place ``201(x)''.

PART 900--MAMMOGRAPHY

    5. The authority citation for 21 CFR part 900 continues to read as 
follows:

    Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

Sec. 900.12  [Amended]

    6. Section 900.12 Quality standards is amended in paragraph 
(e)(5)(iii)(A)(1) by removing ``Cycles/millimeters'' and by adding in 
its place ``Cycles/millimeter'', and in the third sentence of paragraph 
(f)(3) by removing ``results and notifying'' and by adding in its place 
``results and for notifying''.

    Dated: June 27, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-17811 Filed 7-13-00; 8:45 am]
BILLING CODE 4160-01-F