[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Rules and Regulations]
[Pages 34796-34797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. 91N-0278]


New Drug, Antibiotic, and Biological Drug Product Regulations; 
Accelerated Approval; 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 
biologics regulations to correct certain errors that were incorporated 
into the regulations. This action is being taken to improve the 
accuracy of the regulations.

DATES: This rule is effective June 11, 2003.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: FDA has discovered certain errors that were 
inadvertently included in the agency's codified regulations for part 
601 (21 CFR part 601). In the Federal Register of December 11, 1992 (57 
FR 58942), we published a final rule that, among other things, 
established subpart E of part 601, which encompasses Sec. Sec.  601.40 
through 601.46. Currently, Sec.  601.43(a) refers to Sec.  601.40, 
instead of the correct Sec.  601.41; Sec.  601.43(b) refers to Sec.  
601.40, instead of the correct Sec.  601.42. Accordingly, we are 
amending Sec.  601.43(a) by replacing the incorrect reference to Sec.  
601.40 with a reference to Sec.  601.41, and we are amending Sec.  
601.43(b) by replacing the incorrect reference to Sec.  601.40 with a 
reference to Sec.  601.42. 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 601

    Administrative practice and procedure, Biologics, Confidential 
business information.

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Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public 
Health Service Act, and under authority delegated to the Commissioner 
of Food and Drugs, 21 CFR part 601 is amended as follows:

[[Page 34797]]

PART 601--LICENSING

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1. The authority citation for 21 CFR part 601 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 
355, 356B, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 
216, 241, 262, 263, 264; sec. 122, Pub. L. 105-115, 111 Stat. 2322 
(21 U.S.C. 355 note).


Sec.  601.43  [Amended]

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2. Section 601.43 Withdrawal procedures is amended in the introductory 
text of paragraph (a) by removing ``Sec. Sec.  601.40 and 640.42'' and 
adding in its place ``Sec.  601.41 or Sec.  601.42'', and in paragraph 
(b) by removing ``Sec.  601.40 or Sec.  601.41'' and adding in its 
place ``Sec.  601.41 or Sec.  601.42''.

    Dated: June 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14621 Filed 6-10-03; 8:45 am]
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