65 FR 249 pg. 81739 - Drugs for Human Use

Type: RULEVolume: 65Number: 249Page: 81739
FR document: [FR Doc. 00-55519 Filed 12-26-00; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310, 312, and 314

Drugs for Human Use

CFR Correction

In Title 21 of the Code of Federal Regulations, parts 300 to 499, revised as of April 1, 2000, make the following corrections:

1. On page 56, §310.545 is corrected by adding paragraph (d)(2) to read as follows:

§ 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

(d) * * *

(2) February 10, 1992, for products subject to paragraph (a)(20) of this section.

2. On page 61, §312.3(b) is corrected by revising the definition for "Marketing application" to read as follows:

§ 312.3 Definitions and interpretations.

(b) * * *

Marketing application means an application for a new drug submitted under section 505(b) of the act or a biologics license application for a biological product submitted under the Public Health Service Act.

3. In part 314, in both the table of contents on page 97, and in the text on page 165, add "Subpart F[Reserved]".

[FR Doc. 00-55519 Filed 12-26-00; 8:45 am]

BILLING CODE 1505-01-D