[Federal Register Volume 59, Number 54 (Monday, March 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6510]


[[Page Unknown]]

[Federal Register: March 21, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 58 and 314
 

Food and Drugs; Technical Amendments
AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations for good laboratory practice for nonclinical laboratory 
studies and its regulations on applications for FDA approval to market 
a new drug or an antibiotic drug to correct certain inadvertent errors, 
as well as to reflect a recodification of the Federal Food, Drug, and 
Cosmetic Act (the act). This action is editorial in nature and does not 
change the substance of any of the regulations in question.

EFFECTIVE DATE: March 21, 1994.

FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-360), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.
SUPPLEMENTARY INFORMATION: FDA has discovered that certain 
typographical errors have been incorporated into the agency's 
regulations for good laboratory practice for nonclinical laboratory 
studies and its regulations for FDA approval to market a new drug or an 
antibiotic drug. Accordingly, Secs. 58.210(a) and 314.50 (d)(5)(vi)(a) 
are amended as set forth below. In addition, sections 106 and 107 of 
the Prescription Drug User Fee Act of 1992 (Pub. L. 102-571) recodified 
section 706 of the act (21 U.S.C 376) as section 721 of the act (21 
U.S.C. 379e). Accordingly, the citations of authority for 21 CFR parts 
58 and 314 are revised as set forth below. Notice and public procedure 
are unnecessary under the Administrative Procedure Act (5 U.S.C. 553), 
because FDA is merely correcting nonsubstantive, inadvertent errors and 
a statutory recodification.

List of Subjects

21 CFR Part 58

    Laboratories, Reporting and recordkeeping requirements.

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 parts 
58 and 314 are amended as follows:

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY 
STUDIES

    1. The authority citation for 21 CFR part 58 is revised to read as 
follows:

    Authority: Secs. 402, 406, 408, 409, 501, 502, 503, 505, 506, 
507, 510, 512-516, 518-520, 701, 721, 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 
356, 357, 360, 360b-360f, 360h-360j, 371, 379e, 381); secs. 215, 
351, 354-360F of the Public Health Service Act (42 U.S.C. 216, 262, 
263b-263n).


Sec. 58.210 [Amended]

    2. Section 58.210  Actions upon disqualification is amended in the 
fourth sentence of paragraph (a) by removing the words ``such data 
such'' and adding in their place ``such data will''.

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

    3. The authority citation for 21 CFR part 314 is revised to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701, 
704, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 
331, 351, 352, 353, 355, 356, 357, 371, 374, 379e).


Sec. 314.50 [Amended]

    4. Section 314.50  Content and format of an application is amended 
in paragraph (d)(5)(vi)(a) by removing ``(a)(5)(ii)'' and adding in its 
place ``(d)(5)(ii)''.

    Dated: March 15, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-6510 Filed 3-18-94; 8:45 am]
BILLING CODE 4160-01-F