[Federal Register Volume 65, Number 249 (Wednesday, December 27, 2000)]
[Rules and Regulations]
[Page 81739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-55519]


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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, Sec. 310.545 is corrected by adding paragraph (d)(2) 
to read as follows:


Sec. 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, Sec. 312.3(b) is corrected by revising the 
definition for ``Marketing application'' to read as follows:


Sec. 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