[Federal Register Volume 66, Number 7 (Wednesday, January 10, 2001)]
[Rules and Regulations]
[Page 1832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-680]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 98N-0720]


Conforming Regulations Regarding Removal of Section 507 of the 
Federal Food, Drug, and Cosmetic Act; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for applications for FDA approval to market a new drug to 
correct inadvertent errors. This action is necessary to ensure the 
accuracies and consistency of the regulation.

DATES: This rule is effective January 16, 2001.

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 5, 1999 
(64 FR 396), FDA published a direct final rule that removed from the 
agency's regulations references to the now-repealed statutory provision 
of the Federal Food, Drug, and Cosmetic Act (the act) under which the 
agency certified antibiotic drugs (conforming regulation). Section 
314.430(f) (21 CFR 314.430(f)) provides that safety and effectiveness 
data and information in an application may be disclosed to the public 
when certain events happen. Prior to the conforming regulation, 
Sec. 314.430(f)(6) read: ``For applications or abbreviated applications 
submitted under sections 505(j) and 507 of the act, when FDA sends an 
approval letter to the applicant''.
    The conforming regulation inadvertently changed ``section 505(j)'' 
to ``section 505'' and failed to remove the word ``applications'' from 
the introductory clause the first time it appeared. 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 in 21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.


    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
314 is amended as follows:

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

    1. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 374, 
379e.

Sec. 314.430  [Amended]

    2. Section 314.430 Availability for public disclosure of data and 
information in an application or abbreviated application is amended in 
paragraph (f)(6) by removing ``applications or'' and by removing 
``505'' and adding in its place ``505(j)''.

    Dated: January 4, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-680 Filed 1-9-01; 8:45 am]
BILLING CODE 4160-01-F