Drugs for Human Use

---
identifier: "/us/fr/00-55519"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Drugs for Human Use"
title_number: 0
title_name: "Federal Register"
section_number: "00-55519"
section_name: "Drugs for Human Use"
positive_law: false
currency: "2000-12-27"
last_updated: "2000-12-27"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "00-55519"
document_type: "rule"
publication_date: "2000-12-27"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 310"
  - "21 CFR Part 312"
  - "21 CFR Part 314"
fr_citation: "65 FR 81739"
fr_volume: 65
---


#  Definitions and interpretations.

**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

(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

(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]”.